Intense Exercise for Prostate Cancer

(INTERVAL Trial)

Not currently recruiting at 22 trial locations

Overseen By Sam McKeown

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Movember Foundation

Must be taking: ADT

Disqualifiers: Brain metastases, Heart failure, Neuroendocrine tumors, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: up to 5 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if guided high-intensity exercise can help men with metastatic prostate cancer live longer compared to those exercising independently. Participants will either join a group for supervised workouts, which include aerobic and resistance training, or follow their own exercise routine with some support. The trial suits men whose prostate cancer has spread despite treatment and who can safely engage in intense exercise without major health issues like heart failure or recent strokes. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance exercise guidelines for men with metastatic prostate cancer.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, it does require that all participants continue androgen deprivation therapy (ADT) or have had a prior bilateral orchiectomy. It's best to discuss your specific medications with the trial coordinators.

What prior data suggests that this exercise protocol is safe for patients with metastatic prostate cancer?

Research shows that supervised exercise is generally safe for people with prostate cancer. A review of studies found these exercise programs effective and safe, particularly in reducing fatigue for cancer survivors. Another study found that combining aerobic exercises (such as walking or cycling) with resistance exercises (like weightlifting) can enhance the quality of life for men with prostate cancer.

Moreover, evidence suggests that supervised exercise likely surpasses inactivity in improving disease-related quality of life. While the studies focus on safety and effectiveness, they also indicate that supervised exercise can help manage body changes from treatments like hormone therapy.

Overall, these findings demonstrate that supervised exercise is well-tolerated by men with prostate cancer and can provide additional health benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the supervised exercise approach for prostate cancer because it emphasizes high-intensity aerobic and resistance exercise, which is not typically a focus in standard treatments like surgery, radiation, or hormone therapy. This exercise regimen aims to empower patients through self-management, supplemented by psychosocial support, potentially enhancing overall well-being and quality of life. Additionally, the self-directed exercise group offers flexibility and personal agency, encouraging patients to integrate physical activity into their lives at their own pace while still receiving valuable psychosocial support.

What evidence suggests that supervised exercise could be an effective treatment for metastatic prostate cancer?

Research has shown that supervised exercise, which participants in this trial may receive, can be very beneficial for people with prostate cancer. Studies have found that combining strength and aerobic exercises can significantly improve quality of life, including mental sharpness and sexual health. Specifically, supervised high-intensity interval training (HIIT) has motivated men with prostate cancer and provided clear health benefits. Evidence also suggests that supervised exercise reduces tiredness for patients undergoing cancer treatment. Additionally, exercise has improved erectile function in prostate cancer patients compared to standard care. These findings highlight the effectiveness of supervised exercise in boosting overall health and well-being for prostate cancer patients. ^{3 6 7 8 9}

Who Is on the Research Team?

Robert Newton

Principal Investigator

Edith Cowan University

Fred Saad

Principal Investigator

Centre hospitalier de l'Université de Montréal (CHUM)

Are You a Good Fit for This Trial?

This trial is for men with metastatic prostate cancer who have not started or are stable on certain treatments, without serious health issues like heart failure or recent major surgery. They should be able to exercise intensely, not already doing vigorous workouts regularly, and must understand the language used at the study site.

Inclusion Criteria

- PSA Progression: PSA ≥2 ng/ml that has risen serially on at least two occasions, each at least one week apart (PSA1 < PSA2 < PSA3).

My prostate cancer has shown new growths on a PSMA PET/CT scan.

I am taking Abi/Enza/Apa for prostate cancer and my condition is stable or improving.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in either supervised high intensity aerobic and resistance exercise or self-directed exercise with psychosocial support

up to 5 years

Regular visits every three cycles

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Psychosocial support
• Supervised Exercise

Trial Overview The trial tests if high intensity aerobic and resistance training under supervision can improve survival in metastatic prostate cancer patients compared to those who do self-directed exercises. It also looks into the benefits of psychosocial support alongside physical training.

How Is the Trial Designed?

Group I: Arm B: Self directed exercise group Experimental Treatment 1 Intervention

Self directed exercise and psychosocial support group

Group II: Arm A: Supervised exercise group Active Control 2 Interventions

Supervised high intensity aerobic and resistance exercise tapering to self management with psychosocial support

Who Is Running the Clinical Trial?

Movember Foundation

Lead Sponsor

Trials

15

Recruited

41,800+

Centre hospitalier de l'Université de Montréal (CHUM)

Collaborator

Trials

389

Recruited

143,000+

King's College London

Collaborator

Trials

772

Recruited

26,130,000+

Epworth Healthcare

Collaborator

Trials

5

Recruited

12,700+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

Edith Cowan University

Collaborator

Trials

10

Recruited

1,500+

Published Research Related to This Trial

A supervised exercise program combining endurance and resistance training significantly improved various health markers in 27 prostate cancer patients undergoing androgen-deprivation therapy, including muscular endurance and cardiorespiratory fitness.

Participants also experienced improvements in quality of life, as evidenced by better performance in the six-minute walk test and reduced depression levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of a supervised six-month exercise program in patients with prostate cancer receiving androgen-deprivation therapy]. Caty, G., Salazar Gajardo, S., Butoescu, V., et al.[2019]

Exercise interventions, including aerobic and resistance training, are safe for men undergoing androgen-deprivation therapy for prostate cancer and can improve muscular strength, cardiorespiratory fitness, functional performance, and reduce fatigue.

While exercise shows promise in mitigating some adverse effects of treatment, the effects on bone health, cardiometabolic risk, and quality of life remain unclear, indicating a need for further high-quality research to establish specific exercise guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of exercise on treatment-related adverse effects for patients with prostate cancer receiving androgen-deprivation therapy: a systematic review. Gardner, JR., Livingston, PM., Fraser, SF.[2022]

This study aims to evaluate the safety and efficacy of a 3-month modular multi-modal exercise program for 90 prostate cancer survivors with bone metastases, addressing concerns about muscle atrophy and functional impairments due to prior treatments.

The exercise program is designed to be safe for patients with bone metastases, potentially improving physical function and delaying skeletal complications, which could significantly enhance the quality of life for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of a modular multi-modal exercise program in prostate cancer patients with bone metastases: a randomized controlled trial. Galvão, DA., Taaffe, DR., Cormie, P., et al.[2022]

This phase III randomized controlled trial involves 866 participants with metastatic castrate-resistant prostate cancer (mCRPC) to assess whether supervised high-intensity aerobic and resistance exercise can improve overall survival compared to self-directed exercise.

The study will also explore the relationship between exercise and various health factors, such as immune function and metabolic biomarkers, which may help understand how exercise impacts survival outcomes in mCRPC patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intense Exercise for Survival among Men with Metastatic Castrate-Resistant Prostate Cancer (INTERVAL-GAP4): a multicentre, randomised, controlled phase III study protocol. Newton, RU., Kenfield, SA., Hart, NH., et al.[2022]

A systematic review of 33 randomized controlled trials involving 2567 participants found that exercise has a small positive effect on cancer-specific quality of life (QoL) in men with prostate cancer, but the effect is not strongly influenced by the type of exercise performed.

Aerobic exercise was particularly effective in improving cardiovascular fitness (moderate to large effect) and had significant benefits on lower body strength, mental health, and blood pressure, highlighting its importance in enhancing metabolic health for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do Patients with Prostate Cancer Benefit from Exercise Interventions? A Systematic Review and Meta-Analysis. Andersen, MF., Midtgaard, J., Bjerre, ED.[2022]

A supervised exercise training intervention integrated into standard prostate cancer care was feasible and well-accepted, with 79% of eligible participants (36 out of 45) receiving the intervention despite COVID-19 lockdowns.

Participants engaged in an average of 27 minutes of aerobic exercise per session, achieving 92% of their target heart rate, and completed the program without serious adverse events, indicating the safety and potential benefits of exercise in managing the side effects of androgen deprivation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Embedding supervised exercise training for men on androgen deprivation therapy into standard prostate cancer care: a feasibility and acceptability study (the STAMINA trial). Reale, S., Turner, RR., Sutton, E., et al.[2021]

A six-month supervised exercise program significantly improved physical performance, muscular strength, and quality of life in 27 prostate cancer patients undergoing androgen deprivation therapy.

The exercise program was well tolerated and highlighted the need for screening cardio-metabolic risk factors in these patients, as they initially presented with an unfavorable cardio-metabolic profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a six-month supervised physical exercise program on physical and cardio-metabolic profile and quality of life in patients with prostate cancer on androgen deprivation therapy: a pilot and feasibility study. Zabegalina, NS., Henderickx, MMEL., Lamotte, V., et al.[2022]

A systematic review of 21 trials involving 1748 prostate cancer patients found that resistance exercise significantly improved body composition, functional capacity, and muscle strength, with a notable reduction in fat mass and an increase in lean mass.

The study suggests that lower volume resistance training at moderate to high intensity is just as effective as higher volume training, which may help make exercise more accessible and encourage adherence among patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resistance Exercise Dosage in Men with Prostate Cancer: Systematic Review, Meta-analysis, and Meta-regression. Lopez, P., Taaffe, DR., Newton, RU., et al.[2023]

A study involving 57 prostate cancer patients with bone metastases showed that a multimodal exercise program significantly improved self-reported physical functioning and lower body muscle strength after 3 months, compared to usual care.

The exercise program was safe, with no reported exercise-related adverse events or skeletal fractures, indicating that supervised exercise can be beneficial for patients with bone metastases without increasing the risk of complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Preserves Physical Function in Prostate Cancer Patients with Bone Metastases. Galvão, DA., Taaffe, DR., Spry, N., et al.[2022]

The 'Football Club (FC) Prostate' study is a randomized trial involving 80 men undergoing androgen deprivation therapy (ADT) for advanced prostate cancer, aiming to evaluate the effects of soccer training on various health outcomes over a 12-week period.

The primary focus is on changes in lean body mass, with secondary outcomes including cardiovascular function and patient-reported quality of life, potentially demonstrating that soccer training can be a safe and effective rehabilitation strategy for men receiving ADT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of recreational soccer in men with prostate cancer undergoing androgen deprivation therapy: study protocol for the 'FC Prostate' randomized controlled trial. Uth, J., Schmidt, JF., Christensen, JF., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11674139/

The Effect of Resistance and/or Aerobic Training on Quality of ... The results show that combining strength and aerobic exercise significantly improves quality of life, especially in general health, mental clarity, and sexual ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9524100/

Effects of supervised high-intensity interval training on ... Men with prostate cancer on active surveillance were largely motivated and expected significant benefits from a supervised HIIT program.

3. nature.com nature.com/articles/s41391-021-00450-0

a systematic review and meta-analysis | Prostate Cancer ... Evidence of moderate quality shows that supervised exercise therapy probably is superior to no exercise therapy in improving 'disease-specific quality of life' ...

4. sciencedirect.com sciencedirect.com/org/science/article/pii/S1765283924000169

Effectiveness of supervised combined aerobic and ... Supervised combined aerobic and resistance training was proven to significantly improve fatigue in patients with prostate cancer under androgen deprivation ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2831323

Exercise and Psychosexual Education to Improve Sexual ... In this randomized clinical trial including 112 patients with prostate cancer, exercise improved erectile function compared with usual care.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8607248/

A Clinical trial of High‐intensity Aerobic and resistance ... Exercise may improve clinical and quality of life outcomes for men with prostate cancer. No randomized controlled trials (RCTs) have ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1551714423003117

A comparison of aerobic- and resistance-emphasised ... Most exercise studies in men with prostate cancer have utilised single exercise groups that combine resistance and aerobic exercise [[21], [22], ...

8. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0263918

The effects of exercise on body composition of prostate cancer ... Exercise can help ameliorate the adverse effects of androgen deprivation therapy in body composition, with combination exercises including resistance exercise.

9. mdpi.com mdpi.com/2076-3417/15/15/8399

A Systematic Review and Meta-Analysis on the Effects of ... Conclusions: Supervised therapeutic exercise programs are effective and safe for reducing fatigue in breast and prostate cancer survivors. These interventions ...