Low to Moderate Load Power Training for Men With Metastatic Prostate Cancer.

NCT07572760 | Recruiting

• 1 other identifier: UA-2024-01- 23_2
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if a low to moderate load power training program is feasible and effective for improving fitness and quality of life of people with prostate cancer under androgen suppression therapy and bone or lymph node metastasis. The main questions it aims to answer are:

• Does a low to moderate load power training program improve quality of life in people with metastatic prostate cancer under androgen deprivation therapy?
• Does a low to moderate load power training program improve power, strength, endurance, and balance in people with metastatic prostate cancer under androgen deprivation therapy? Researchers will compare the exercise program with routine care to see if power training works to improve common physical side effects of androgen suppression therapy in patients with metastatic prostate cancer. Participants will:
• Participate in a supervised exercise program twice a week for 6 months or maintain routine care.
• Perform fitness tests and questionnaires about quality of life and mental health.
• Those who take part in the exercise program will also perform semi-structured in-depth interviews after the end of the program.

Conditions

Prostatic Neoplasms

Keywords

Prostate cancer; Strength training; Power training; Quality of life; Mental health; Functional capacity; Exercise; Prostatic; Neoplasm; Androgen; Deprivation; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases; Urogenital Diseases; Prostatic Neoplasms; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Metastasis; Metastatic prostate cancer; Androgen deprivation; Testosterone

Outcome Measures

Primary Outcomes (1)

• Health-related quality of life

  Quality of life will be assessed using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire. This instrument includes the Functional Assessment of Cancer Therapy-General (FACT-G) and a prostate cancer-specific subscale, providing a multidimensional assessment of physical, social/family, emotional, and functional well-being, as well as prostate cancer-related symptoms and concerns. The total score will be used for analysis, with higher scores indicating better quality of life. Results will be expressed in points, with a score range of 0 to 156. In addition, quality of life will be complemented by a final semi-structured interview exploring participants' perceptions and experiences after the intervention.

  From enrollment to the end of the exercise program at 6 months.

Secondary Outcomes (11)

• Rate of Force Development

  From enrollment to the end of the exercise program at 6 months.

• Lower-body strength

  From enrollment to the end of the exercise program at 6 months.

• Handgrip strength

  From enrollment to the end of the exercise program at 6 months.

• Functional mobility

  From enrollment to the end of the exercise program at 6 months.

• Gait speed

  From enrollment to the end of the exercise program at 6 months.

Study Arms (2)

Power training group

EXPERIMENTAL

The intervention consists of a supervised power-oriented resistance training program for older men with metastatic prostate cancer undergoing androgen deprivation therapy (ADT). Participants will complete 2 sessions per week over 24 weeks. Training focuses on improving muscle power through exercises performed at moderate intensity (40-50% 1RM), emphasizing a fast concentric phase and controlled eccentric phase. Multi-joint functional exercises targeting major muscle groups are included to enhance strength, balance, and daily functional performance. Training volume is low-to-moderate, and participants do not train to muscular failure, allowing maintenance of movement velocity and reducing fatigue. Adequate rest periods are provided between sets. The program is adapted to the clinical characteristics of the population, minimizing mechanical stress while promoting neuromuscular improvements. It is designed to be safe, feasible, and well-tolerated.

Other: Power training group

Control group

NO INTERVENTION

Participants will continue with their usual care and will receive standardized information and guidance on how to remain physically active at home.

Interventions

Power training group OTHER

The intervention consists of a supervised power-oriented resistance training program for older men with prostate cancer undergoing androgen deprivation therapy (ADT). Participants will complete 2 sessions per week over 24 weeks. Training focuses on improving muscle power through exercises performed at moderate intensity (40-50% 1RM), emphasizing a fast concentric phase and controlled eccentric phase. Multi-joint functional exercises targeting major muscle groups are included to enhance strength, balance, and daily functional performance. Training volume is low-to-moderate, and participants do not train to muscular failure, allowing maintenance of movement velocity and reducing fatigue. Adequate rest periods are provided between sets. The program is adapted to the clinical characteristics of the population, minimizing mechanical stress while promoting neuromuscular improvements. It is designed to be safe, feasible, and well-tolerated, with the aim of improving functional capacity.

Power training group

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histopathologically confirmed diagnosis of prostate adenocarcinoma.
• Metastatic hormone-sensitive prostate cancer (mHSPC), defined as:
• Presence of metastases at initial diagnosis (synchronous mHSPC), or
• Development of metastatic disease following prior treatment with curative intent (surgery and/or radiotherapy) (metachronous mHSPC).
• Evidence of progression to castration-resistant prostate cancer (CRPC).
• Ongoing treatment with a doublet regimen consisting of standard androgen deprivation therapy (ADT) in combination with an androgen receptor signaling inhibitor (ARSI), initiated prior to study enrollment.
• Receipt of bone-protective therapy, including calcium and vitamin D supplementation in combination with bisphosphonates.
• Presence of metastatic involvement limited to bone and/or lymph nodes.
• Functionally independent in activities of daily living.

You may not qualify if:

• Evidence of visceral metastatic disease.
• Current or prior treatment with a triplet regimen that includes chemotherapy.
• History of pathological fracture.

Sponsors & Collaborators

• University of Alicante: lead
• Hospital General Universitario Dr. Balmis de Alicante: collaborator

Study Sites (1)

University of Alicante

San Vicent del Raspeig, Alicante, 03690, Spain

RECRUITING

Related Publications (22)

• Aagaard, P., Simonsen, E. B., Andersen, J. L., Magnusson, P., Dyhre-poulsen, P., & Dyhre-Poulsen, P. (2002). Neural adaptation to resistance training: changes in evoked V-wave and H-reflex responses. J Appl Physiol, 92, 2309-2318. https://doi.org/10.1152/japplphysiol.01185

  BACKGROUND

• Bassyouny, N. M., Gouda, M. M., El Din, M. M. E., Sweed, H. S., El Akkad, R. M., Bassyouny, N., & Eldin, M. E. (2024). Impact of Androgen deprivation therapy on cognitive function of elderly men with Prostate Cancer. Cureus, 16(9). doi: 10.7759/cureus.69303

  BACKGROUND

• Bigaran, A., Zopf, E., Gardner, J., La Gerche, A., Murphy, D. G., Howden, E. J., ... & Cormie, P. (2021). The effect of exercise training on cardiometabolic health in men with prostate cancer receiving androgen deprivation therapy: a systematic review and meta-analysis. Prostate Cancer and Prostatic Diseases, 24(1), 35-48. https://doi.org/10.1038/s41391-020-00273-5

  BACKGROUND

• Cormie, P., Turner, B., Kaczmarek, E., Drake, D., & Chambers, S. K. (2015). A qualitative exploration of the experience of men with prostate cancer involved in supervised exercise programs. Oncol Nurs Forum, 42(1), 24-32. DOI: 10.1188/15.ONF.24-32

  BACKGROUND

• El Hadouchi, M., de Boer, M., & de Vries, N. M. (2025). The impact of power training on muscle power, physical performance, and functional independence in older adults. Clinical Interventions in Aging, 20, 849-857. https://doi.org/10.2147/CIA.S511954

  BACKGROUND

• Gardner, J. R., Livingston, P. M., & Fraser, S. F. (2014). Effects of exercise on treatment-related adverse effects for patients with prostate cancer receiving androgen-deprivation therapy: a systematic review. Journal of Clinical Oncology, 32(4), 335-346. DOI: 10.1200/JCO.2013.49.5523

  BACKGROUND

• Lopez, P., Taaffe, D. R., Newton, R. U., Buffart, L. M., & Galvão, D. A. (2021). What is the minimal dose for resistance exercise effectiveness in prostate cancer patients? Systematic review and meta-analysis on patient-reported outcomes. Prostate Cancer and Prostatic Diseases, 24(2), 465-481. https://doi.org/10.1038/s41391-020-00301-4

  BACKGROUND

• Maffiuletti, N. A., Aagaard, P., Blazevich, A. J., Folland, J., Tillin, N., & Duchateau, J. (2016). Rate of force development: physiological and methodological considerations. European Journal of Applied Physiology, 116(6), 1091-1116. https://doi.org/10.1007/s00421-016-3346-6

  BACKGROUND

• Massoeurs, L., Ilie, G., Lawen, T., MacDonald, C., Bradley, C., Vo, J. D. C.-T., & Rutledge, R. D. H. (2021). Psychosocial and functional predictors of mental disorder among prostate cancer survivors: Informing survivorship care programs with evidence-based knowledge. Current Oncology, 28(5), 3918-3931. https://doi.org/10.3390/curroncol28050334

  BACKGROUND

• Rantaniemi, L., Jussila, I., Siltari, A., Ahtiainen, J. P., Hakulinen, A., Harju, E., ... & Murtola, T. J. (2025). Is Exercise During Androgen Deprivation Therapy Effective and Safe? A Randomized Controlled Trial. Scandinavian Journal of Medicine & Science in Sports, 35(6). https://doi.org/10.1111/sms.70084

  BACKGROUND

• Raval, A. D., Chen, S., Littleton, N., Constantinovici, N., & Goebell, P. J. (2025). Real-world use of androgen-deprivation therapy intensification for metastatic hormone-sensitive prostate cancer: a systematic review. BJU International, 135(3), 408-421. https://doi.org/10.1111/bju.16577

  BACKGROUND

• Rodríguez-Rosell, D., Pareja-Blanco, F., Aagaard, P., & González-Badillo, J. J. (2018). Physiological and methodological aspects of rate of force development assessment in human skeletal muscle. Clinical Physiology and Functional Imaging, 38(5), 743-762. https://doi.org/10.1111/cpf.12495

  BACKGROUND

• Shao, W., Zhang, H., Qi, H., & Zhang, Y. (2022). The effects of exercise on body composition of prostate cancer patients receiving androgen deprivation therapy: An update systematic review and meta-analysis. PLoS One, 17(2), https://doi.org/10.1371/journal.pone.0263918

  BACKGROUND

• Taaffe, D. R., Newton, R. U., Spry, N., Joseph, D., Chambers, S. K., Gardiner, R. A., Wall, B. A., Cormie, P., Bolam, K. A., & Galvão, D. A. (2017). Effects of different exercise modalities on fatigue in prostate cancer patients undergoing androgen deprivation therapy: A year-long randomised controlled trial. European Urology. https://doi.org/10.1016/j.eururo.2017.02.019

  BACKGROUND

• Teleni, L., Chan, R. J., Chan, A., Isenring, E. A., Vela, I., Inder, W. J., & McCarthy, A. L. (2016). Exercise improves quality of life in androgen deprivation therapy-treated prostate cancer: systematic review of randomised controlled trials. Endocrine-related cancer, 23(2), 101-112. https://doi.org/10.1530/ERC-15-0456

  BACKGROUND

• Tian, S., Ding, M., & Sun, H. (2022). The effects of resistance exercise on body composition and physical function in prostate cancer patients undergoing androgen deprivation therapy: an update systematic review and meta-analysis. Aging Male, 25(1), 281-292. https://doi.org/10.1080/13685538.2022.2146670

  BACKGROUND

• Tortosa-Martínez, J., Beltrán-Carrillo, V. J., Romero-Elías, M., Ruiz-Casado, A., Jiménez-Loaisa, A., & González-Cutre, D. (2023). "To be myself again": Perceived benefits of group-based exercise for colorectal cancer patients. European Journal of Oncology Nursing, 66, 102405. https://doi.org/10.1016/j.ejon.2023.102405

  BACKGROUND

• Wilson, R. L., Vulczak, A., Morgans, A. K., Norris, M., Greer, J., Votta, J., ... & Dieli-Conwright, C. M. (2025). Design of debunking the frailty-sarcopenia-ADT axis in metastatic prostate cancer with multicomponent exercise: the FIERCE trial protocol. Frontiers in Sports and Active Living, 7, 1602123. https://doi.org/10.3389/fspor.2025.1602123

  BACKGROUND

• Winters-Stone, K. M., et al. (2014). Skeletal response to resistance and impact training in prostate cancer survivors on androgen deprivation therapy: The POWIR trial. Journal of Bone and Mineral Research, 29(3), 1-9. doi: 10.1249/MSS.0000000000000265

  BACKGROUND

• Winters-Stone KM, Dobek JC, Bennett JA, et al. (2015). Resistance training reduces disability in prostate cancer survivors on androgen deprivation therapy: evidence from a randomized controlled trial. Arch Phys Med Rehabil, 96, 7-14. https://doi.org/10.1016/j.apmr.2014.08.010

  BACKGROUND

• Yunfeng, G., Weiyang, H., Xueyang, H., Yilong, H., & Xin, G. (2017). Exercise overcome adverse effects among prostate cancer patients receiving androgen deprivation therapy: an update meta-analysis. Medicine, 96(27), e7368. DOI: 10.1097/MD.0000000000007368

  BACKGROUND

• Ziaee, S., Chu, G. C. Y., Huang, J. M., Sieh, S., & Chung, L. W. K. (2015). Prostate cancer metastasis: Roles of recruitment and reprogramming, cell signal network and three-dimensional growth characteristics. In Translational Andrology and Urology, 4(4), 438-454. https://doi.org/10.3978/j.issn.2223-4683.2015.04.10

  BACKGROUND

Related Links

• Ethics Committee approval document

MeSH Terms

Conditions

Prostatic Neoplasms; Psychological Well-Being; Motor Activity; Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases; Urogenital Diseases; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Personal Satisfaction; Behavior; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: May 7, 2026
• Study Start: April 10, 2024
• Primary Completion (Estimated): November 10, 2026
• Study Completion (Estimated): December 10, 2026
• Last Updated: May 7, 2026

Record last verified: 2026-04

Locations

ES (1)