Your session is about to expire
← Back to Search
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
INTERVAL Trial 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.Check my eligibility
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.See study design
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.
INTERVAL Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
INTERVAL Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival
Secondary outcome measures
Analgesic Use
Biomarker analysis
Disease Progression
+5 moreINTERVAL 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?
King's College LondonOTHER
719 Previous Clinical Trials
25,755,554 Total Patients Enrolled
9 Trials studying Prostate Cancer
3,259 Patients Enrolled for Prostate Cancer
Centre hospitalier de l'Université de Montréal (CHUM)OTHER
366 Previous Clinical Trials
128,771 Total Patients Enrolled
5 Trials studying Prostate Cancer
2,109 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
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.My prostate cancer is high-risk based on its Gleason score, bone lesions, or visceral lesions.I am currently on hormone therapy for cancer or have had both testicles surgically removed.I do not have small cell neuroendocrine tumors.My prostate cancer is resistant to medical or surgical treatments.I have taken Docetaxel or similar drugs for prostate cancer without getting worse.My cancer is stable or improving on Abi/Enza/Apa after first-line chemotherapy.My prostate cancer is advanced with high-risk or high-volume spread.My doctor says I can do a heart-lung exercise test and intense workouts.I am fully active or can carry out light work.It's been over 4 weeks since my last major surgery and I have fully recovered.I don't have serious health issues that prevent me from doing intense exercise.I am 18 years old or older.My prostate cancer is worsening on Abi/Enza/Apa treatment, but I have no symptoms and won't start chemotherapy within 6 months.I haven't started any standard treatments for advanced prostate cancer.My condition is metastatic hormone-sensitive prostate cancer.My prostate cancer is resistant to medical or surgical treatments.I have advanced cancer with multiple bone and possibly organ metastases.My latest bone scan shows new lesions due to prostate cancer.My cancer has grown by more than 20% or I have new cancer spots.My prostate cancer has spread and is not responding to hormone therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A: Supervised exercise group
- Group 2: Arm B: Self directed exercise group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many research sites are actively participating in this exploration?
"Patients are being recruited for this medical trial at Centre Hospitalier de l'Université de Montréal (CRCHUM) in Montreal, Nova Scotia, QEII Cancer Centre / Dalhousie University in Halifax, Alberta and University of Alberta in Edmonton. Additionally, 6 other locations have been included as part of the recruitment process."
Answered by AI
How many people are eligible to participate in the experiment?
"Affirmative. Clinicaltrials.gov shows that the trial, which was initially posted on January 1st 2016 and last modified on May 12th 2022, is actively seeking volunteers. 866 individuals are needed to be enrolled from 6 sites."
Answered by AI
Are there any vacancies in the clinical trial yet?
"Affirmative. According to the clinicaltrials.gov listing, this medical experiment is recruiting presently and was initially posted on January 1st 2016 with a most recent update occurring on May 12th 2022. 866 participants are sought from 6 distinct sites."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger