Intense Exercise for Prostate Cancer

(INTERVAL Trial)

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

866 Participants Needed

Trial Summary

What is the purpose of this trial?

To determine if supervised high intensity aerobic and resistance training increases overall survival compared to self-directed exercise in patients 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 data supports the effectiveness of the treatment Psychosocial support, Supervised Exercise for prostate cancer?

Research shows that exercise can improve quality of life and metabolic health in men with prostate cancer, with aerobic exercise being particularly beneficial for cardiovascular fitness. Supervised exercise programs have shown positive effects on physical health and quality of life in patients undergoing hormone therapy for prostate cancer. ^{1 2 3 4 5}

Is intense exercise safe for prostate cancer patients?

Supervised exercise programs, including both endurance and resistance training, have been shown to be safe for prostate cancer patients, even those receiving androgen-deprivation therapy. Studies report no serious adverse events, and exercise can help improve physical fitness and quality of life. ^{3 6 7 8 9}

How does supervised exercise differ from other treatments for prostate cancer?

Supervised exercise is unique because it focuses on improving physical function and reducing the side effects of prostate cancer treatments like androgen deprivation therapy, especially in patients with bone metastases. Unlike traditional treatments, it aims to enhance muscle strength and overall health through a structured exercise program, which is not typically part of standard cancer care. ^{10 11 12 13 14}

Research Team

Robert Newton

Principal Investigator

Edith Cowan University

Fred Saad

Principal Investigator

Centre hospitalier de l'Université de Montréal (CHUM)

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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]

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]

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]

References

1. Poland 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. [2022]

2. England 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. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Comparing eccentric resistance exercise in prostate cancer survivors on and off hormone therapy: a pilot study. [2015]

4. Germany pubmed.ncbi.nlm.nih.gov

Exercise prescription dose for castrate-resistant prostate cancer patients: a phase I prescription dose escalation trial. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Do Patients with Prostate Cancer Benefit from Exercise Interventions? A Systematic Review and Meta-Analysis. [2022]

6. Belgium pubmed.ncbi.nlm.nih.gov

[Evaluation of a supervised six-month exercise program in patients with prostate cancer receiving androgen-deprivation therapy]. [2019]

7. England 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). [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Resistance Exercise Dosage in Men with Prostate Cancer: Systematic Review, Meta-analysis, and Meta-regression. [2023]

9. United States 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. [2022]

10. England 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. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Exercise Preserves Physical Function in Prostate Cancer Patients with Bone Metastases. [2022]

12. England 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. [2021]

13. New Zealand pubmed.ncbi.nlm.nih.gov

Exercise and prostate cancer. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

A multi-centre investigation of delivering national guidelines on exercise training for men with advanced prostate cancer undergoing androgen deprivation therapy in the UK NHS. [2022]