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Abstract

Background

Digital therapeutics (DTx) has emerged as a transformative approach in healthcare, offering innovative solutions for disease management and treatment optimization. Prostate cancer (PCa), the second most common malignancy in men, has seen increasing incidence rates, driving the development of new digital technologies for PCa management.

Purpose

This review aims to provide a comprehensive analysis of the current status and effectiveness of DTx in managing PCa.

Methods

Based on the framework of Arksey and O'Malley's scoping review and the PRISMA-ScR guidelines, a systematic search was conducted in major domestic and international databases. The search aimed to retrieve studies on DTx for PCa from database inception to November 2024. The retrieved data were systematically summarized and analyzed using descriptive numerical summaries and thematic content analysis.

Results

A total of 23 studies were included. The study types were primarily randomized controlled trials. The application forms of DTx included internet-based platforms, mobile health, and wearable devices. The primary focus of DTx applications in PCa patients included survivorship support, symptom management and side-effect monitoring, psychological support and emotional management, patient education and self-management, health management and rehabilitation, and treatment adherence management.

Conclusion

DTx demonstrates diverse applications in the management of PCa and has shown potential in improving patients’ quality of life. Future research should integrate DTx with diagnosis and therapeutic approaches, with a particular emphasis on developing DTx tools tailored explicitly for PCa patients. High-quality randomized controlled trials should be prioritized to validate these interventions further.

Keywords

Digital therapeutics prostate cancer disease management scoping review digital health

Prostate cancer (PCa) is the second most common cancer in men and the fifth leading cause of cancer-related mortality worldwide. In 2020, an estimated 1.4 million new cases were diagnosed globally, accounting for 7.3% of all cancer diagnoses and approximately 375,000 deaths.¹ Ongoing advances in diagnostic techniques and treatment modalities have steadily increased survival rates for patients with PCa, promoting the paradigm of “living with cancer” and contributing to the growing recognition of cancer as a chronic disease. Despite improved survival rates, patients with PCa in the “living with cancer” or “disease-free survival” stages often face numerous challenges, including treatment-related side effects, symptom burden, fear of recurrence, interpersonal difficulties, psychological distress, and social isolation. These factors significantly impair quality of life and cause substantial suffering.^2,3 Financial burdens are also considerable, with annual PCa management costs estimated at USD22bn in the United States, making it one of the most expensive cancers to treat.⁴ In Europe, related healthcare expenditures total EUR8.5bn annually.⁵ At the same time, a cross-sectional study in Iran estimated the national economic burden in 2021 at approximately USD217m,⁶ underscoring the growing global financial impact of PCa. Nevertheless, outcomes in PCa management remain suboptimal, with many patients reporting poor quality of life.⁷ This may be due to the traditional emphasis on core therapeutic interventions (surgery, radiotherapy, and chemotherapy), the uneven distribution of medical resources, and the limitations of conventional healthcare models bound by time and location. Collectively, these factors restrict the availability of cost-effective, universally accessible treatment options across temporal and geographical boundaries.

In recent years, the emergence and advancement of mobile health (mHealth) have attracted growing research interest, demonstrating substantial potential in disease management. Several studies have examined the effectiveness of mHealth and smartphone applications in supporting disease management for patients with PCa and improving their quality of life.^8,9 However, despite the widespread use of mHealth interventions and software-based medical devices claiming to enhance disease management and quality of life, few products are developed with active involvement from healthcare professionals, and their efficacy is rarely subjected to rigorous validation. Digital therapeutics (DTx), evidence-based medical interventions driven by high-quality software programs, are applicable for the prevention, management, and treatment of various diseases.¹⁰ They have been widely implemented in chronic disease management in Europe and the Americas.^11,12 Owing to its non-invasive and accessible nature, DTx can overcome many of the limitations inherent to traditional education and management approaches, making it a promising tool for the long-term health management of PCa patients. Therefore, this study aims to review the scope of DTx in disease management among PCa patients, analyze the capability of DTx products to enhance disease management outcomes, and provide recommendations for future research on DTx-related interventions for PCa patients.

Methods

This study followed the scoping review report framework proposed by Arksey and O'Malley¹³ in 2005, comprising the following steps: (1) clarifying research objectives and research questions; (2) searching for relevant studies; (3) selecting studies relevant to the research question; (4) charting the data; and (5) organizing, synthesizing, and reporting the results. The findings of this study are reported according to the PRISMA-ScR guidelines.¹⁴ As this review was conducted to map the existing evidence on the topic rapidly, registration of the protocol in PROSPERO was not required, consistent with the nature of scoping reviews.¹⁵

Defining research questions

The following research questions guide this scoping review: (1) What types of studies have investigated the application of DTx in patients with PCa? (2) What are the application forms of DTx in disease management for PCa patients? (3) What are the specific contents of DTx interventions for PCa patients, including intervention targets, content, and duration? (4) What is the effectiveness of DTx in the application for PCa patients?

Literature search and retrieval

We conducted a comprehensive search for relevant studies. The following databases were systematically searched: China National Knowledge Infrastructure, Wanfang Data, China Biology Medicine, China Science and Technology Journal Database (VIP), PubMed, Embase, Web of Science, Cochrane Library, and CINAHL. The search covered the period from database inception to November 1, 2024. Both subject headings and free-text terms were employed to ensure comprehensive retrieval. The search terms included prostate cancer, prostatic cancer, prostate tumor, prostatic tumor, robot-assisted laparoscopic radical prostatectomy, prostatectomy, prostatic neoplasms; digital therapeutics, phone, software, app, internet, mHealth, eHealth, telehealth, smart devices, sensors, wearables, health information technology, personalized medicine, digital technologies, digital technology, digital therapeutic, telemedicine, digital health, wearable device, health information technology, electronic health records, personalized medicine. The detailed search strategy is provided in the Appendix, with PubMed used as an example. Additionally, to identify additional relevant studies, we reviewed the reference lists of all included studies, examined related review studies to identify their original research, and tracked research protocols to obtain their complete results.

Study selection

Eligibility criteria based on the population, concept, and context principle

Inclusion criteria:
Population (P): Patients diagnosed with PCa, encompassing the entire lifespan from diagnosis to end-of-life care.

Concept (C): Interventions involving DTx were provided to PCa patients. If software is utilized for multiple conditions (e.g. PCa and colorectal cancer), such studies will also be eligible.

Context (C): Studies reporting changes in health-related outcomes among PCa patients in the context of DTx interventions. This study is limited to peer-reviewed original journal articles, papers, and dissertations published in Chinese or English. The included study designs comprise randomized controlled trials (RCTs), quasi-experimental studies, and mixed-methods research.

Exclusion criteria:

Articles without accessible full texts were excluded. Additionally, studies driven by software tools such as phone calls, text messages, emails, and WeChat, which were not explicitly developed for PCa survivors, were also excluded.

Literature screening and data extraction

A comprehensive search of relevant literature was conducted to ensure no potentially eligible studies were missed. The reference lists of relevant systematic and scoping reviews were also screened. The retrieved literature was imported into EndNote 19.0, and duplicate studies were removed. Two researchers independently reviewed the titles and abstracts of the retrieved papers. All retrieved records were imported into EndNote 19.0, and duplicates were removed. Two reviewers independently screened the titles and abstracts, with discrepancies resolved through consultation with a third reviewer. Full-text screening was then performed according to the predefined inclusion and exclusion criteria, and the final set of studies was confirmed through cross-checking.

Data extraction

Data were extracted from the screened studies and organized using Microsoft Excel. A predesigned table was utilized to systematically extract and organize the data, including authorship, country of publication, year, study type, study population, sample size, intervention content, duration of intervention, and intervention outcomes. Data extraction was conducted independently by one reviewer and verified by another reviewer, with any discrepancies resolved through consultation with a third reviewer.

Data analysis

Quantitative results were presented using descriptive numerical measures, while qualitative data were analyzed using a thematic content analysis approach, with information systematically extracted and summarized.^16,17 The intervention content reported in the included studies was coded, and these codes were then grouped into primary thematic categories. Findings were presented in alignment with the primary research question. The coding and thematic extraction process was conducted using Microsoft Excel. All authors collectively participated throughout all stages of the analysis, and any discrepancies were discussed and resolved through consensus.

Results

Included studies overview

The initial search retrieved a total of 17,047 studies, of which 6498 duplicates were removed. Following title and abstract screening, 10,341 studies were excluded for being unrelated to the topic or for being conference abstracts. Full-text review, 174 studies were excluded based on the inclusion and exclusion criteria, resulting in 23 studies being ultimately included in the final analysis (Figure 1).^18–40

Figure 1.
PRISMA flowchart for study selection and assessment.

The study types included RCTs (n = 16),^{18–22,24,26,28,30,32,33,36–40} non-randomized controlled studies (n = 5),^{27,29,31,34,35} and mixed-methods studies (n = 2).^23,25 The geographic distribution of the included United States (n = 6),^{19,27,32,33,37,39} Sweden (n = 3),^24,35,38 United Kingdom (n = 3),^18,23,31 Canada (n = 3),^26,29,34 Australia (n = 2),^20,28 South Korea (n = 2),^30,40 Netherlands (n = 1),²¹ Germany (n = 1),²⁵ Norway (n = 1),³⁶ and Italy (n = 1).²² Most studies included only PCa patients (n = 15), while five studies included patients with other conditions, such as colorectal cancer and breast cancer. Three studies included both PCa patients and their spouses or family caregivers. The baseline characteristics of the included studies are summarized in Table 1.

Table 1.
Included literature characteristics.

Author Year Nation Experimental design Research object Intervention methods Duration of intervention Result

Golsteijn et al.²¹ 2023 Netherlands RCT PCa patients undergoing treatment The intervention group (n = 149) was treated with OncoActive intervention, while the control group (n = 143) had no special intervention 3 months Patients experienced a significant reduction in fatigue

Sundberg et al.³⁵ 2017 Sweden Non-randomized control PCa radiotherapy patients The intervention group (n = 66) was treated with Interaktor intervention, while the control group (n = 64) had no special intervention 8–11 weeks Patients had a significant reduction in fatigue, nausea levels and emotional function, insomnia, and the burden of urinary-related symptoms

Evans et al.²⁸ 2021 Australia RCT Patients with metastatic PCa The intervention group (n = 20) was treated with ExerciseGuide intervention, while the control group (n = 20) had no special intervention 8 weeks Patients had increased levels of moderate to vigorous physical activity

Ruland et al.³⁶ 2013 Norway RCT Had PCa and was being treated Intervention group (n = 66) used WebChoice for intervention, control group used the open cancer website URL, experimental group (n = 70) 1 year The patient's symptoms and distress were alleviated, and depression was improved

Song et al.³² 2021 United States RCT Men and their partners who have completed initial treatment for localized PCa The intervention group used the PERC intervention website, and the control group used the NCI website 15 weeks Patients reported better urinary symptom scores, fewer visits, and improvements in quality of life and some coping resources (self-efficacy and information society support) for patients and partners

Wittmann et al.³⁷ 2022 United States RCT Patients with localized PCa and their partners The intervention group (n = 62) was treated with TrueNTH, while the control group (n = 80) had no special intervention 6 months Patients had increased sexual activity

Bender et al.³⁴ 2022 Canada One-arm pre- and post-control trial PCa patients receiving treatment or follow-up and their caregiver True North Peer Navigation was used to intervene with PCa patients (n = 29) and their caregivers (n = 5). 3 months Patients’ activation, quality of life improved, and fear of unmet needs decreased

Trinh et al.²⁹ 2018 Canada Prospective one-arm trial Patients with localized or asymptomatic metastatic primary PCa receiving ADT Patients (n = 46) received RiseTx intervention 12 weeks Sedentary behavior decreased, moderate-to-vigorous physical activity, and step count increased

Cockle-Hearne et al.²³ 2018 United Kingdom Pre-post, within-participant comparison, mixed-methods design Men diagnosed with PCa who are not receiving palliative care for metastatic disease Patients (phase I, n = 8; phase II, n = 16) received the intervention for Getting Down to Coping 4 weeks Patients’ baseline pain was improved

Kenfield et al.¹⁹ 2019 United States RCT Men with low-risk PCa The intervention group (n = 38) received a digital lifestyle intervention, and the control group (n = 38) received usual care 12 weeks Patients showed significant improvement in eating behavior, but no increase in vigorous activity or brisk walking

Falz et al.²⁰ 2023 Australia RCT PCa patients diagnosed with stage T1N0M0-T3N3M0 The intervention group (n = 23) received Cancer-Telemonitoring and Self-management application, while the control group (n = 22) received routine nursing 6 months The oxygen uptake of patients during exercise increases, and the workload of the myocardium decreases

Park et al.⁴⁰ 2021 Korea RCT PCa patients on androgen deprivation therapy The intervention group (n = 86) was treated with the Smart After-Care service, while the control group (n = 86) had no special intervention 12 weeks Patients showed improvements in cardiorespiratory endurance, muscle mass, obesity, and health-related quality of life

Wennerberg et al.³⁸ 2024 Sweden RCT Men undergoing radical prostatectomy The intervention group (n = 83) was treated with ePATH, while the control group (n = 82) was treated with routine nursing 12 months ePATH had no impact on patient activation during long-term PCa rehabilitation

Van Blarigan et al.³⁹ 2024 United States RCT Patients with stage T2 or lower prostate adenocarcinoma who have never received treatment The intervention group was tested with an active Surveillance Exercise, while the control group had no special intervention 16 weeks Patients have improved cardiorespiratory fitness, reduced urinary tract obstruction/irritation, and reduced fear of recurrence

Peeke et al.²⁷ 2024 United States Single-arm prospective study Patient had a history of PCa treatment and had experienced hot flashes for at least 30 days The intervention group (n = 44) was treated with a new wearable thermal device 4 weeks Patient's hot flashes improved

Carli et al.²² 2022 Italy RCT PCa patients The intervention group (n = 49) was treated with NEVERMIND, while the control group (n = 51) had no special intervention 12 weeks NEVERMIND can reduce and prevent depressive symptoms in patients

Grapp et al.²⁵ 2022 Germany Pre-post, within-participant comparison, mixed-methods research design PCa chemotherapy patients Patients (n = 5) were treated with OPaCT 8 stages (no specific time) OPaCT has the potential to reduce the unmet psychological care needs of patients undergoing chemotherapy

Lambert et al.²⁶ 2022 Canada RCT Men with PCa who have received treatment or plan to receive treatment The intervention group (n = 26) received TEMPO and the control group (n = 23) received routine nursing 3 months Patients’ anxiety was improved, and their quality of life was improved

Little et al.¹⁸ 2023 United Kingdom RCT PCa patients who completed primary treatment (≤10 years ago) and had a QLQ-C30 score <85 Intervention group 1 (n = 906) received Renewed care, intervention group 2 (n = 903) received Renewed and support, and control group (n = 903) received conventional care 12 months Patients’ global health and quality of life improved

Lee et al.³⁰ 2019 Korea RCT PCa patients who have undergone surgery or androgen deprivation therapy The intervention group (n = 48) used a smartphone app and a pedometer to promote physical activity, and the control group (n = 48) used a pedometer to record physical activity 12 ± 1 weeks There was no significant difference in promoting physical activity between the two groups

Tagai et al.³³ 2021 United States RCT Patients with localized PCa diagnosed with stage T1-T3C The intervention group (n = 217) was treated with the PROGRESS intervention, while the control group (n = 214) was treated with enhanced routine intervention 6 months Patients’ ability to cope with the transfer of health concerns improved, but it does not adequately address the remaining coping and psychosocial domains

O'Connor et al.³¹ 2021 United Kingdom Single-arm study PCa patients receiving supportive care Intervention with LifeGuide software (n = 109) 3 months Patient's sex life improved

Hauffman et al.²⁴ 2020 Sweden RCT PCa patients The intervention group (n = 24) was treated with iCAN-DO, while the control group (n = 28) was treated with routine nursing 10 weeks Patients’ depressive symptoms improved

PCa: prostate cancer; RCT: randomized controlled trial; PERC: patient education resources for couples; NCI: National Cancer Institute; OPaCT: guided biopsychosocial online intervention for cancer patients undergoing chemotherapy; ADT: androgen deprivation therapy.

Application forms

DTx interventions applied to PCa survivors were delivered through the internet, mHealth, and wearable devices. Among the 23 included studies, the implementation platforms of DTx intervention were website (n = 11),^{18,23–26,28,31–33,36,37} apps (n = 5),^{21,22,34,35,38} apps combined with wearable devices (n = 4),^20,30,39,40 websites combined with wearable devices (n = 2),^19,29 and wearable devices alone (n = 1).²⁷ Internet platforms were primarily used to provide health education information or recommendations, such as exercise plans or content promoting physical activity. Apps served to monitor and share health-related data, including functionalities for reminders, symptom assessment, and tracking. Wearable devices were utilized to monitor and track physical activity, such as devices like Fitbit, pedometers, or other activity monitors, often equipped with additional technologies to provide feedback or adjust goals. Wearable devices, including Fitbit, pedometers, and other activity monitors, were employed to track physical activity and often incorporated additional technologies to provide feedback or adjust goals. Intervention durations ranged from 1 week to 12 months, with 3-month and 6-month interventions being the most common.

Intervention content

DTx is primarily applied to PCa survivors in the following aspects:
Survivorship support: Nine studies demonstrated that DTx provided comprehensive support for patients,^{19,23,25,28,32–34,36,38} encompassing life support,^25,33,38 personalized support,³⁴ medical assistance,³⁶ social support,^19,32 informational guidance,^28,34 peer support,^23,34 and other forms of support.²⁸ These interventions were multifaceted; for example, nurses used platforms such as webChoice to address cancer-related challenges in daily life, reducing the need for clinical visits and promoting recovery and rehabilitation.³⁶ DTx also offered nursing information on daily exercise, disease prevention, and nutritional counseling, enabling patients to manage their condition better and enhance their quality of life. In addition, these interventions facilitated peer and social support, fostering both disease recovery and a sense of community among survivors.

Symptom management and side-effect monitoring: Five studies demonstrated the effectiveness of DTx in managing symptoms and monitoring adverse effects in PCa patients.^{22,27,32,35,36} These interventions often utilized sensors and internet-based approaches to ameliorate disease-related symptoms and treatment side effects, including urinary-related issues, sexual dysfunction, hormonal symptoms, pain, fatigue, sleep disorders, and stress. For instance, during radiation therapy, patients could use the interactive smartphone application Interaktor for symptom reporting, which triggers alerts for nurses to contact patients and reduce their symptom burden.³⁵ Additionally, hot flashes, a common side effect of androgen deprivation therapy, were alleviated by a wrist-worn thermal device providing dynamic cooling to the inner wrist.²⁷ DTx thus offers new opportunities for symptom management, enhancing the quality of life for PCa survivors.

Psychological support and emotional management: Five studies demonstrated the effectiveness of DTx in providing psychological support and emotional management interventions for PCa patients.^22–26 The interventions were grounded in several theoretical frameworks, including the stress and coping framework, the dual coping framework, self-efficacy theory, psychosocial education, Orem's self-care deficit nursing theory, and social cognitive theory.^24,26 The primary intervention methods included cognitive-behavioral therapy,^22,23 mindfulness training,²² guided bio-psycho-social online interventions,²⁵ and guided imagery exercises.²⁵ DTx primarily utilized a mobile-based cognitive restructuring module to correct patients’ catastrophic thoughts about PCa and its side effects.²⁶ Additionally, by integrating wearable devices to collect physiological indicators with machine learning algorithms, dynamic warnings regarding psychological states were implemented, thereby improving anxiety, depression, and other related psychological conditions among PCa survivors. These digital interventions contributed to a more comprehensive and personalized approach to psychological support and emotional management.

Patient education and self-management: Eleven studies demonstrated that DTx enabled patient education and self-management.^{19–25,32–34,36} These interventions were frequently grounded in theories of behavior change, with social cognitive theory^21,24,34 and cognitive behavioral therapy theory^22–24 being the most commonly utilized frameworks, providing a solid theoretical foundation. Through digital platforms, patients received personalized interventions, real-time feedback, and access to educational content related to PCa treatment, diet, exercise, and lifestyle modifications, which effectively enhanced their self-management capabilities.

Health management and rehabilitation: Twelve studies demonstrated that DTx were effective in supporting health management and rehabilitation.^{18–26,28–31,37,39,40} These interventions incorporated mHealth applications, wearable devices, and artificial intelligence (AI) algorithms, focusing on lifestyle interventions and personalized health guidance. DTx platforms were capable of automatically generating individualized feedback, integrating behavioral interventions with lifestyle prescriptions, and embedding health management and rehabilitation into daily life. This approach promoted patient adherence to exercise, improved overall health, prevented disease progression, and effectively enhanced patient outcomes.

Treatment adherence management: Five studies demonstrated that DTx improved patient treatment adherence,^{28,34–36,39} including adherence to medical visits,^35,36 physical activity,²⁸ timely treatment,³⁴ and active monitoring.³⁹ These interventions integrated mHealth applications, smart reminder systems, and behavior intervention tools to track treatment behaviors and health data. This allowed healthcare teams to monitor adherence in real time and adjust intervention strategies as needed. Through digital platforms, patients could receive reminders for medical visits, personalized exercise prescriptions, and instructions for active self-monitoring via digital platforms, which enhanced their adherence and reduced the risk of disease progression.

Intervention effects

DTx has demonstrated considerable potential in improving clinical outcomes, enhancing treatment efficacy, and elevating the quality of life for patients with PCa. These interventions integrate mHealth applications, wearable devices, and AI algorithms to enable real-time monitoring of physiological indicators, behavioral patterns, and overall health status. Among the 23 studies, most (n = 21) reported positive outcomes,^{18–29,31–37,39,40} while only two reported negative results.^30,38 Notably, the studies indicated improvements in various areas, including mental health (n = 7),^{22–26,35,36} oxygen uptake and cardiopulmonary function (n = 3),^20,39,40 overall quality of life (n = 3),^26,34,40 fatigue (n = 2),^21,35 physical activity levels (n = 2),^25,29 urinary system symptoms (n = 2),^32,35 and sexual function (n = 2).^31,37 Additionally, studies highlighted improvements in dietary behavior,¹⁹ hot flashes,²⁷ and general health status.¹⁸ In conclusion, DTx has been shown to improve mental health, physical activity, health status, urinary symptoms, fatigue, sexual function, and dietary behavior, thereby demonstrating substantial clinical value in the management of PCa.

Discussion

DTx, as an innovative healthcare paradigm, has demonstrated significant potential in the management of PCa in recent years. However, their application remains in the early stages, with a growing number of studies since 2013, predominantly in high-income countries such as the United States,^{19,27,32,33,37,39} Sweden,^24,35,38 the United Kingdom,^18,23,31 and Canada.^26,29,34 This trend may be attributed to technological support and implementation costs, which limit the adoption of digital applications in low- and middle-income countries.^41,42 Despite the substantial efforts in some of these regions to leverage digital healthcare to improve health outcomes, the lack of research remains striking.⁴³ Overall, achieving equitable access to and utilization of DTx presents a considerable challenge. To address the specific healthcare challenges in low- and middle-income countries, numerous digital health programs have already been piloted.⁴⁴ Future research and development should continue to prioritize the advancement of DTx in these regions, ensuring their potential benefits are realized globally.

The internet (n = 13)^{18,19,23–26,28,29,31–33,36,37} was the most commonly used platform for DTx to PCa patients. This prevalence may be attributed to its scalability, broad reach, cost-effectiveness, and ease of access.²⁸ These findings are consistent with prior research demonstrating that web-based interventions effectively enhance patient engagement and deliver inclusive benefits to wider populations.⁴⁵ However, because PCa patients often include a large proportion of older adults, interventions tailored to this demographic require specific design considerations (e.g. text-to-speech options and adjustable font sizes). Therefore, further emphasis should be placed on the design, content, format, and acceptability of digital platform interventions for older populations.

DTx has demonstrated diverse applications in the management of PCa, including survival support, symptom management and adverse effect monitoring, psychological support and emotional regulation, patient education and self-management, health management and rehabilitation, and treatment adherence. Among these, physical activity interventions have been the most frequently studied (n = 12),^{18–21,26,28–30,33,38–40} primarily focusing on promoting walking and home-based exercises to enhance patient engagement and adherence. These interventions have shown potential to reduce the risk of PCa progression, alleviate long-term fatigue, mitigate negative emotional states, and ultimately improve patients’ overall health and quality of life. These findings are consistent with prior research and are further supported by the American Cancer Society's Nutrition and Physical Activity Guidelines for Cancer Survivors, which emphasize sufficient evidence supporting the role of physical activity during cancer treatment in managing quality of life.⁴⁶ Therefore, integrating DTx into physical activity interventions for PCa patients is strongly recommended, as they may contribute to cancer prevention.⁴⁷ However, current physical activity programs vary widely and have primarily been validated in small-sample sizes. Future research should focus on developing standardized, evidence-based, and patient-safe DTx to optimize physical activity interventions for this population.

Overall, DTx has shown promising effectiveness in the management of PCa. A total of 21 studies have shown positive outcomes, including improvement in long-term fatigue,²¹ dietary behavior,¹⁹ physical activity levels,^{18,20,21,28,29} psychological well-being,^22–26 overall health status,¹⁸ and urinary-related symptoms.^32,35 Additionally, patients reported significant improvements in sexual satisfaction compared to baseline levels.^31,37 While the evidence remains preliminary, these findings suggest that DTx can promote both physical and mental health and underscore its considerable potential in disease management. Furthermore, DTx has been widely accepted by PCa patients. For example, Grapp and colleagues reported that 80.4% of participants completed the guided biopsychosocial online intervention for cancer patients undergoing chemotherapy, with both qualitative and quantitative data indicating high levels of participant satisfaction.²⁵ These findings are consistent with prior research demonstrating that patients are receptive to digital health interventions.⁴⁸ Therefore, DTx are not only practical but also feasible in the management of PCa, providing valuable references for future research.

Despite the considerable potential of DTx in managing PCa, its application still faces several challenges and limitations. Although DTx has demonstrated promise in supporting patients through survival support, symptom management, side-effect monitoring, psychological support, patient education, self-management, health management, rehabilitation, and treatment adherence, current research indicates that its use in the screening, diagnosis, and active treatment of PCa remains limited. Given that PCa management is a complex, lifelong process spanning all disease stages, further development of digital tools is needed to address the specific requirements of patients at different stages of their illness. Second, most existing DTx are not specifically designed for PCa patients, and validation is often conducted across diverse populations, resulting in a lack of disease-specific interventions for PCa. Additionally, the long-term efficacy of DTx remains insufficiently validated, as many studies rely on small-sample sizes, focus primarily on short-term outcomes, and provide limited assessment of sustained improvements in patients’ quality of life. Finally, the widespread adoption and application of DTx is constrained by factors such as technological accessibility, patients’ digital literacy, and unequal distribution of healthcare resources. For instance, in regions with limited healthcare infrastructure, patients may lack the necessary technical support, hindering broader implementation.

Future research should prioritize several key directions. First, it is essential to explore the integration of DTx with traditional and innovative diagnostic and therapeutic strategies. For example, Ferro et al.⁴⁹ demonstrated that AI can learn from large datasets to improve predictive algorithms, offering significant potential to enhance the diagnosis, prognosis, and treatment of urological diseases, including bladder cancer. Similarly, in the future, innovative diagnostic technologies for PCa can be combined with DTx to enhance diagnostic efficiency. For example, Cicatiello et al.⁵⁰ highlighted the significant potential of circulating microRNAs and liquid biopsy in the diagnosis, monitoring, and treatment of PCa. In the future, incorporating molecular data from the microRNA profiles of liquid biopsies into DTx platforms could significantly enhance risk prediction and facilitate the development of personalized treatment plans. Additionally, Rapisarda et al.⁵¹ conducted an innovative study comparing suspicious PCa lesions identified via multiparametric magnetic resonance imaging (mpMRI) and biopsy with the histological reports from the surgical histologic report for the side of the lesion. They further compared the consistency between mpMRI-based Prostate Imaging-Reporting and Data System (PIRADS) scores and Gleason scores based on biopsy and surgical histologic reports for the side of the lesion. The study demonstrated a strong agreement between consistency between Gleason scores, PIRADS ≥3, and clinically significant cancers. Therefore, integrating PIRADS scores and Gleason patterns into AI-driven DTx platforms could drive diagnostic innovation, enhance the accuracy of PCa detection, significantly improve real-time risk stratification, and support more precise and timely clinical decision-making. This integration of DTx with clinical diagnostics and treatments has the potential to address existing gaps in DTx for PCa across different disease stages, thereby supporting a more comprehensive management framework. Second, the development of PCa-specific DTx tools could facilitate more precise and personalized patient management. However, further high-quality RCTs are needed to establish the long-term efficacy and safety of these interventions. Collectively, such efforts may broaden the application of DTx and strengthen its role in PCa management.

In conclusion, DTx holds considerable promise for the management of PCa. By combining advanced information technology with clinical expertise, these interventions can enhance patients’ self-management while simultaneously providing healthcare professionals with stronger evidence-based decision-making support. However, achieving this goal will require further foundational research, technical refinement, and the establishment of supportive policies. With continued technological innovation and closer integration into clinical practice, DTx is expected to become an essential component of PCa management, offering patients greater benefits and improving overall outcomes.

Limitations

Although this study provides a systematic review of research on DTx for PCa, several limitations should be noted. First, most available studies are based on small-sample sizes, which may constrain both the representativeness and the statistical power of their findings. Small-sample studies often fail to capture the diverse populations undergoing PCa screening, which may limit the generalizability of their conclusions, especially when assessing the broader applicability of DTx. Second, this study does not include a critical appraisal of the methodological quality of the reviewed literature. Due to the nature of scoping reviews, we were unable to perform detailed assessments of study design rigor, risk of bias, or result reliability, which may affect the overall credibility and robustness of the findings. Additionally, this review was limited to articles published in Chinese and English, thereby excluding studies in other languages (e.g. Spanish, French). Such language restriction may have led to the omission of relevant research, particularly from non-English-speaking countries, which could have reduced the comprehensiveness of the review. Finally, the outcome assessment tools varied considerably across studies, reflecting a lack of standardized measures. This diversity in assessment tools hinders direct comparisons and precise synthesis of research findings, thereby limiting the effective integration of existing evidence. In conclusion, future studies should aim to include larger sample sizes to improve statistical power and enhance the generalizability of results. When conducting scoping reviews, incorporating an assessment of the methodological quality of included studies is essential to improve the credibility and reliability of the findings. Efforts should also be made to address language barriers by including studies published in multiple languages (e.g. Spanish, French, German). Moreover, establishing standardized evaluation criteria or prioritizing widely recognized assessment tools would facilitate more effective comparison and integration of results.

Conclusion

DTx shows great potential for enhancing disease management in PCa patients by integrating advanced technologies. They can support survival, symptom management, and side-effect monitoring; provide psychological support and emotional management; facilitate patient education and self-management; promote health management and rehabilitation; and optimize treatment adherence, thereby improving patient prognosis and quality of life. To maximize the impact of DTx, future research should prioritize its integration with both conventional and emerging diagnostic and therapeutic strategies, thereby contributing to a more comprehensive disease management framework. Particular emphasis should be placed on conducting high-quality RCTs to establish robust evidence on their safety and efficacy. Additionally, developing patient-specific DTx tools tailored to the diverse needs of PCa patients across all stages of treatment is essential. By presenting a comprehensive review of DTx applications in PCa management, this study provides a valuable theoretical foundation for advancing research and clinical practice in the field.

Author	Year	Nation	Experimental design	Research object	Intervention methods	Duration of intervention	Result
Golsteijn et al.²¹	2023	Netherlands	RCT	PCa patients undergoing treatment	The intervention group (n = 149) was treated with OncoActive intervention, while the control group (n = 143) had no special intervention	3 months	Patients experienced a significant reduction in fatigue
Sundberg et al.³⁵	2017	Sweden	Non-randomized control	PCa radiotherapy patients	The intervention group (n = 66) was treated with Interaktor intervention, while the control group (n = 64) had no special intervention	8–11 weeks	Patients had a significant reduction in fatigue, nausea levels and emotional function, insomnia, and the burden of urinary-related symptoms
Evans et al.²⁸	2021	Australia	RCT	Patients with metastatic PCa	The intervention group (n = 20) was treated with ExerciseGuide intervention, while the control group (n = 20) had no special intervention	8 weeks	Patients had increased levels of moderate to vigorous physical activity
Ruland et al.³⁶	2013	Norway	RCT	Had PCa and was being treated	Intervention group (n = 66) used WebChoice for intervention, control group used the open cancer website URL, experimental group (n = 70)	1 year	The patient's symptoms and distress were alleviated, and depression was improved
Song et al.³²	2021	United States	RCT	Men and their partners who have completed initial treatment for localized PCa	The intervention group used the PERC intervention website, and the control group used the NCI website	15 weeks	Patients reported better urinary symptom scores, fewer visits, and improvements in quality of life and some coping resources (self-efficacy and information society support) for patients and partners
Wittmann et al.³⁷	2022	United States	RCT	Patients with localized PCa and their partners	The intervention group (n = 62) was treated with TrueNTH, while the control group (n = 80) had no special intervention	6 months	Patients had increased sexual activity
Bender et al.³⁴	2022	Canada	One-arm pre- and post-control trial	PCa patients receiving treatment or follow-up and their caregiver	True North Peer Navigation was used to intervene with PCa patients (n = 29) and their caregivers (n = 5).	3 months	Patients’ activation, quality of life improved, and fear of unmet needs decreased
Trinh et al.²⁹	2018	Canada	Prospective one-arm trial	Patients with localized or asymptomatic metastatic primary PCa receiving ADT	Patients (n = 46) received RiseTx intervention	12 weeks	Sedentary behavior decreased, moderate-to-vigorous physical activity, and step count increased
Cockle-Hearne et al.²³	2018	United Kingdom	Pre-post, within-participant comparison, mixed-methods design	Men diagnosed with PCa who are not receiving palliative care for metastatic disease	Patients (phase I, n = 8; phase II, n = 16) received the intervention for Getting Down to Coping	4 weeks	Patients’ baseline pain was improved
Kenfield et al.¹⁹	2019	United States	RCT	Men with low-risk PCa	The intervention group (n = 38) received a digital lifestyle intervention, and the control group (n = 38) received usual care	12 weeks	Patients showed significant improvement in eating behavior, but no increase in vigorous activity or brisk walking
Falz et al.²⁰	2023	Australia	RCT	PCa patients diagnosed with stage T1N0M0-T3N3M0	The intervention group (n = 23) received Cancer-Telemonitoring and Self-management application, while the control group (n = 22) received routine nursing	6 months	The oxygen uptake of patients during exercise increases, and the workload of the myocardium decreases
Park et al.⁴⁰	2021	Korea	RCT	PCa patients on androgen deprivation therapy	The intervention group (n = 86) was treated with the Smart After-Care service, while the control group (n = 86) had no special intervention	12 weeks	Patients showed improvements in cardiorespiratory endurance, muscle mass, obesity, and health-related quality of life
Wennerberg et al.³⁸	2024	Sweden	RCT	Men undergoing radical prostatectomy	The intervention group (n = 83) was treated with ePATH, while the control group (n = 82) was treated with routine nursing	12 months	ePATH had no impact on patient activation during long-term PCa rehabilitation
Van Blarigan et al.³⁹	2024	United States	RCT	Patients with stage T2 or lower prostate adenocarcinoma who have never received treatment	The intervention group was tested with an active Surveillance Exercise, while the control group had no special intervention	16 weeks	Patients have improved cardiorespiratory fitness, reduced urinary tract obstruction/irritation, and reduced fear of recurrence
Peeke et al.²⁷	2024	United States	Single-arm prospective study	Patient had a history of PCa treatment and had experienced hot flashes for at least 30 days	The intervention group (n = 44) was treated with a new wearable thermal device	4 weeks	Patient's hot flashes improved
Carli et al.²²	2022	Italy	RCT	PCa patients	The intervention group (n = 49) was treated with NEVERMIND, while the control group (n = 51) had no special intervention	12 weeks	NEVERMIND can reduce and prevent depressive symptoms in patients
Grapp et al.²⁵	2022	Germany	Pre-post, within-participant comparison, mixed-methods research design	PCa chemotherapy patients	Patients (n = 5) were treated with OPaCT	8 stages (no specific time)	OPaCT has the potential to reduce the unmet psychological care needs of patients undergoing chemotherapy
Lambert et al.²⁶	2022	Canada	RCT	Men with PCa who have received treatment or plan to receive treatment	The intervention group (n = 26) received TEMPO and the control group (n = 23) received routine nursing	3 months	Patients’ anxiety was improved, and their quality of life was improved
Little et al.¹⁸	2023	United Kingdom	RCT	PCa patients who completed primary treatment (≤10 years ago) and had a QLQ-C30 score <85	Intervention group 1 (n = 906) received Renewed care, intervention group 2 (n = 903) received Renewed and support, and control group (n = 903) received conventional care	12 months	Patients’ global health and quality of life improved
Lee et al.³⁰	2019	Korea	RCT	PCa patients who have undergone surgery or androgen deprivation therapy	The intervention group (n = 48) used a smartphone app and a pedometer to promote physical activity, and the control group (n = 48) used a pedometer to record physical activity	12 ± 1 weeks	There was no significant difference in promoting physical activity between the two groups
Tagai et al.³³	2021	United States	RCT	Patients with localized PCa diagnosed with stage T1-T3C	The intervention group (n = 217) was treated with the PROGRESS intervention, while the control group (n = 214) was treated with enhanced routine intervention	6 months	Patients’ ability to cope with the transfer of health concerns improved, but it does not adequately address the remaining coping and psychosocial domains
O'Connor et al.³¹	2021	United Kingdom	Single-arm study	PCa patients receiving supportive care	Intervention with LifeGuide software (n = 109)	3 months	Patient's sex life improved
Hauffman et al.²⁴	2020	Sweden	RCT	PCa patients	The intervention group (n = 24) was treated with iCAN-DO, while the control group (n = 28) was treated with routine nursing	10 weeks	Patients’ depressive symptoms improved

Footnotes

Acknowledgments

The authors thank the patients and staff for their participation in the study.

ORCID iDs

Minna Chen

Xiaoru Wu

Lifen Chen

Ying Wang

Author contributions

Minna Chen: project design and direction and manuscript preparation. Xiaoru Wu: project design, manuscript preparation, and chart preparation. Lifen Chen: manuscript revision. Ying Wang: paper screening.

Declaration of conflicting interests

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study was supported by the Nursing Research Project of the First Affiliated Hospital, Zhejiang University School of Medicine (2022ZYHL004).

Ethical considerations

Not applicable.

Consent for publication

All authors agree to submit the manuscript to the journal.

Data availability

No data was generated in this study, and data availability is not appropriate for this article.

Appendix

Taking PubMed as an example:

#1 ("Prostate"[Mesh]) OR "Prostatic Neoplasms"[Mesh]

#2 ((("Telemedicine"[Mesh]) OR "Digital Health"[Mesh]) OR "Internet"[Mesh]) OR "Mobile Applications"[Mesh]

#3 digital therapeutics[Title/Abstract] OR phone[Title/Abstract] OR software[Title/Abstract] OR app[Title/Abstract] OR internet[Title/Abstract] OR mHealth[Title/Abstract] OR eHealth[Title/Abstract] OR telehealth[Title/Abstract] OR smart devices[Title/Abstract] OR sensors[Title/Abstract] OR wearables[Title/Abstract] OR health information technology[Title/Abstract] OR personalized medicine[Title/Abstract] OR Digital Technologies[Title/Abstract] OR Digital Technology[Title/Abstract] OR digital therapeutic[Title/Abstract] OR Telemedicine[Title/Abstract] OR digital health[Title/Abstract] OR wearable device[Title/Abstract] OR health information technology[Title/Abstract] OR electronic health records[Title/Abstract] OR personalized medicine[Title/Abstract]

#4 prostate cancer[Title] OR prostatic cancer[Title] OR prostate tumor[Title] OR prostatic tumor[Title] OR Robot-assisted laparoscopic radical prostatectomy[Title] OR prostatectomy[Title] OR Prostatic Neoplasms[Title]

#5 #1 OR #4

#6 #2 OR #3

#7 #5 AND #6

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The role of digital therapeutics in the management of prostate cancer: A systematic scoping review

Abstract

Background

Purpose

Methods

Results

Conclusion

Keywords

Methods

Defining research questions

Literature search and retrieval

Study selection

Eligibility criteria based on the population, concept, and context principle

Literature screening and data extraction

Data extraction

Data analysis

Results

Included studies overview

Application forms

Intervention content

Intervention effects

Discussion

Limitations

Conclusion

Footnotes

Acknowledgments

ORCID iDs

Author contributions

Declaration of conflicting interests

Funding

Ethical considerations

Consent for publication

Data availability

Appendix

References