INTERVAL: INTense Exercise foR surVivAL in Men With Metastatic Prostate Cancer
Clinicaltrials.gov identifier:
NCT02730338
Quality of Life:
Prostate Cancer Survivor
Study Contact Information:
For additional information, please contact :
Anthony Treacy by email or
Jennette Sison by phone at: (415)885-3692 or by email
INTense Exercise foR surVivAL Among Men With Metastatic Castrate-Resistant Prostate Cancer (INTERVAL)
About the Study
This study will determine if high intensity aerobic and resistance training (with supervised exercise) plus psychosocial support increases overall survival compared to psychosocial support alone (with self-directed exercise) in patients with metastatic castrate-resistant prostate cancer.
Type of Study
This is a randomized parallel assignment study with two arms.
- This is a randomized study, which means that participants will be placed into one of the two study arms by chance. Neither patients nor the research doctor will choose the group participants are placed in.
- One arm is the supervised exercise group, where supervised high intensity aerobic and resistance exercise will taper to self-management with psychosocial support.
- The second arm will be a self-directed exercise group with psychosocial support.
What the Study Entails
- Study participants must be able to travel to one of the study-designated exercise facilities
- up to three days per week during cycle 0 (4 weeks)
- two days per week for cycles 1-8 (32 weeks), and
- once per week for cycles 9-11 (12 weeks).
- Participants will be asked to complete questionnaires and undergo physical assessments every three cycles.
- Participants must be able to attend exercise testing visits as required by the study.
- Participants will be studied for up to five years.
Study Locations
United States
- Colorado
- Denver, CO: UC Denver
- Contact: Elizabeth Kessler by email
- Oregon
- Portland, OR: Oregon Health & Science University
- Contact: Kerri Winters-Stone by email
- Washington
- Seattle, WA Fred Hutchinson Cancer Centre
- Contact: Stephen Plymate by email
- Canada, Alberta
Canada
- Alberta
- Edmonton, Alberta: University of Alberta
- Contact: Kerry Courneya by email
Other international sites are open in the following countries:
- Australia
- China
- Germany
- Netherlands
- United Kingdom
Men, age 18 years or older, who meet the following criteria:
- Patients with metastatic castration-resistant prostate cancer (mCRPC), a cancer that has spread (metastasized) beyond the prostate gland and for which hormone therapy is no longer effective.
At enrollment, patients must fit into one of the following 5 categories:
- Have not yet started approved therapies for CRPC ie: Abiraterone/Enzalutamide/Apalutamide/Docetaxel), Or
- Have received Abi/Enza/Apa for mCRPC and cancer is responding or stable, Or
- Patients with PSA progression while on Abi/Enza/Apa are eligible as long as they are asymptomatic AND there is no plan to start chemotherapy within 6 months, Or
- Patients treated with Docetaxel as first line therapy for mCRPC who are asymptomatic without ANY evidence of progression, Or
- Patients may have progressed following Docetaxel first line and are now receiving treatment with Abi/Enza/Apa. These patients must be responding or stable (PSA values must be stable or declining after starting Abi/Enza/Apa treatment) and have an expected life expectancy of more than 1 year.
Patients must be able to travel to one of the study-designated exercise facilities up to three days per week for four weeks during cycle 0, two days per week for cycles 1-8 (32 weeks) and once per week for cycles 9-11 (12 weeks). In addition, patients must be able to attend exercise testing visits as defined in the study.
Receive medical clearance to undergo and pass a symptom-limited cardiopulmonary exercise test (CPET) and vigorous aerobic and resistance exercise training.
Receive approval after review of patient’s bone scan.
- Disease progression while on treatment with abiraterone, enzalutamide, or a combination.
- Small cell neuroendocrine tumors or pure small cell carcinoma of the prostate.
- Brain metastases.
- Patients receiving experimental treatment with non-approved drugs at the time of enrollment must undergo a 28-day washout between last dose and screening CPET.
- Serious event associated with heart disease within the last 12 months.
- Patients with a currently active second cancer other than non-melanoma skin cancer.
- Serious or non-healing wound, bone fracture, or moderate-to-severe bone pain.
- Men already participating in vigorous aerobic exercise for more than 60 minutes per week or resistance exercise two or more days per week.