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Behavioral Intervention

Intense Exercise for Prostate Cancer (INTERVAL Trial)

N/A
Waitlist Available
Research Sponsored by Movember Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
- PSMA PET/CT scan progression: Appearance of one or more new lesions on PSMA PET/CT scan attributable to prostate cancer.
- Patients treated with Docetaxel, Cabazitaxel or other approved first line chemotherapy as first line for mCRPC who are asymptomatic without ANY evidence of progression Or
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare the effects of different types of exercise on survival rates for men with metastatic prostate cancer.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects from intense exercise may include muscle soreness, fatigue, joint pain, and risk of injury. Psychosocial support generally has no physical side effects but can sometimes bring up emotional discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My prostate cancer has shown new growths on a PSMA PET/CT scan.
Select...
I have taken Docetaxel or similar drugs for prostate cancer without getting worse.
Select...
My prostate cancer is advanced with high-risk or high-volume spread.
Select...
My prostate cancer is high-risk based on its Gleason score, bone lesions, or visceral lesions.
Select...
I am currently on hormone therapy for cancer or have had both testicles surgically removed.
Select...
I do not have small cell neuroendocrine tumors.
Select...
It's been over 4 weeks since my last major surgery and I have fully recovered.
Select...
I don't have serious health issues that prevent me from doing intense exercise.
Select...
I am 18 years old or older.
Select...
I am fully active or can carry out light work.
Select...
I haven't started any standard treatments for advanced prostate cancer.
Select...
My latest bone scan shows new lesions due to prostate cancer.
Select...
My cancer has grown by more than 20% or I have new cancer spots.
Select...
My prostate cancer has spread and is not responding to hormone therapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall Survival
Secondary study objectives
Analgesic Use
Biomarker analysis
Disease Progression
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm B: Self directed exercise groupExperimental Treatment1 Intervention
Self directed exercise and psychosocial support group
Group II: Arm A: Supervised exercise groupActive Control2 Interventions
Supervised high intensity aerobic and resistance exercise tapering to self management with psychosocial support
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psychosocial support
2004
N/A
~210

Find a Location

Who is running the clinical trial?

Centre hospitalier de l'Université de Montréal (CHUM)OTHER
377 Previous Clinical Trials
130,654 Total Patients Enrolled
5 Trials studying Prostate Cancer
2,109 Patients Enrolled for Prostate Cancer
King's College LondonOTHER
761 Previous Clinical Trials
26,129,443 Total Patients Enrolled
9 Trials studying Prostate Cancer
3,259 Patients Enrolled for Prostate Cancer
Epworth HealthcareOTHER
4 Previous Clinical Trials
11,812 Total Patients Enrolled
1 Trials studying Prostate Cancer
10,000 Patients Enrolled for Prostate Cancer
Movember FoundationLead Sponsor
14 Previous Clinical Trials
40,907 Total Patients Enrolled
5 Trials studying Prostate Cancer
35,515 Patients Enrolled for Prostate Cancer
University of California, San FranciscoOTHER
2,591 Previous Clinical Trials
14,900,775 Total Patients Enrolled
52 Trials studying Prostate Cancer
17,597 Patients Enrolled for Prostate Cancer
Edith Cowan UniversityOTHER
9 Previous Clinical Trials
659 Total Patients Enrolled
Robert NewtonStudy ChairEdith Cowan University
Fred SaadStudy ChairCentre hospitalier de l'Université de Montréal (CHUM)
1 Previous Clinical Trials
200 Total Patients Enrolled
1 Trials studying Prostate Cancer
200 Patients Enrolled for Prostate Cancer

Media Library

Supervised Exercise (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT02730338 — N/A
Prostate Cancer Research Study Groups: Arm A: Supervised exercise group, Arm B: Self directed exercise group
Prostate Cancer Clinical Trial 2023: Supervised Exercise Highlights & Side Effects. Trial Name: NCT02730338 — N/A
Supervised Exercise (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02730338 — N/A
~67 spots leftby Oct 2025
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