Exercise Program for Prostate Cancer

(ASX Trial)

Recruiting at 1 trial location

Overseen By June Chan

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of California, San Francisco

Must not be taking: Finasteride, Dutasteride

Disqualifiers: Uncontrolled illness, Heart failure, Cancer, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

104 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase 2, open-label, dual-center, two-arm randomized controlled trial (RCT) investigates the effects of 16 weeks of structured aerobic training, relative to usual care (print material with physical activity guidance). Prostate genomic signatures represent the functional activity of all genes in the genome and are converted into genomic risk scores which correspond to the probability of a progression event (chance of having more aggressive disease). A structured exercise program may alter the genomic risk score and improve prediction of aggressive disease.

Research Team

June Chan, Sc.D.

Principal Investigator

University of California, San Francisco

Eligibility Criteria

Men with localized prostate cancer who've chosen active surveillance and have a Gleason score ≤6 or limited Gleason 3+4, a PSA ≤15 ng/ml (or PSAD <0.15), low to moderate fitness levels, and can pass an exercise test are eligible. Exclusions include recent serious cardiovascular events, uncontrolled illnesses, prior prostate cancer treatments, certain medication use within specified time frames before the study start, and mental impairments.

Inclusion Criteria

I am a man with prostate issues, my PSA is between 10-15, and I have low-risk prostate cancer.

English-speaking

I chose to monitor my low-risk prostate cancer instead of immediate treatment.

Exclusion Criteria

I have an active heart infection.

I haven't taken finasteride in the last 3 weeks or dutasteride in the last 6 months.

I don't have any recent health issues that could worsen with exercise.

Treatment Details

Interventions

• Exercise

Trial Overview This trial examines if a structured aerobic training program over 16 weeks can change genomic risk scores in men with prostate cancer under active surveillance compared to usual care advice. The goal is to see if exercise affects the likelihood of disease progression.

Participant Groups

Group I: Arm A: Exercise Experimental Treatment 2 Interventions

Arm A will engage in up to 4 aerobic sessions per week at 55% to 75% of the individually determined exercise capacity (VO2peak; determined from the cardiopulmonary exercise test (CPET) performed at baseline) for 16 weeks. This exercise prescription will be achieved through \~ 4 sessions / week. Men are provided with a heart rate monitor to help ensure they exercise in their target zone. At baseline \& week 16, all patients will complete: (1) lifestyle and quality-of-life questionnaires, (2) measurement of weight (3) collection of research fasting blood sample, (4) collection of urine sample, and (5) cardiorespiratory fitness testing. Archival biopsy tissue samples from before and after the intervention will also be requested.

Group II: Arm C: Exploratory Active Control 2 Interventions

Arm C is a non-randomized control group of men without cancer, which will receive all baseline and 16 week follow-up assessments (except tissue procurement) will engage in up to 4 aerobic sessions per week at 55% to 75% of the individually determined exercise capacity (VO2peak; determined from the cardiopulmonary exercise test performed at baseline) for 16 weeks. This exercise prescription will be achieved through \~ 4 sessions / week. Men are provided with a heart rate monitor to help ensure they exercise in their target zone. At baseline \& week 16, all patients will complete: (1) lifestyle and quality-of-life questionnaires, (2) measurement of weight (3) collection of research fasting blood sample, (4) collection of urine sample, and (5) cardiorespiratory fitness testing.

Group III: Observational Non-Randomized Group Active Control 1 Intervention

There is also a non-randomized observational component to the study where biospecimens and survey data will be collected and one CPET will be administered. Individuals who will be enrolled to this group include those who do not meet all eligibility criteria for the RCT, or those who do not wish to be in a RCT, but are interested to participate in some lifestyle research.

Group IV: Arm B: Usual Care Active Control 1 Intervention

Arm B will receive print material with physical activity guidance which includes general physical activity information (e.g., "Moving through Cancer - A Guide to Exercise for Cancer Survivors") at baseline, but no specific exercise program or goals. At the conclusion of the 16 weeks, subjects in this group will be provided with a heart rate monitor, an individualized aerobic exercise program based on their cardiorespiratory fitness test results, and opportunity to consult with study exercise physiologist (one-time).

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+