INTense ExeRcise for surviVAL Among Men With Metastatic Prostate Cancer (INTERVAL - GAP4) (INTERVAL)
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|ClinicalTrials.gov Identifier: NCT02730338|
Recruitment Status : Recruiting
First Posted : April 6, 2016
Last Update Posted : May 16, 2022
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Prostate Cancer||Behavioral: High intensity aerobic and resistance training Behavioral: Psychosocial support||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||866 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||INTense ExeRcise for surviVAL Among Men With Metastatic Prostate Cancer (INTERVAL - GAP4): A Multicentre, Randomised, Controlled, Phase III Study|
|Actual Study Start Date :||January 2016|
|Estimated Primary Completion Date :||October 2025|
|Estimated Study Completion Date :||October 2028|
Active Comparator: Arm A: Supervised exercise group
Supervised high intensity aerobic and resistance exercise tapering to self management with psychosocial support
Behavioral: High intensity aerobic and resistance training
Behavioral: Psychosocial support
Arm B: Self directed exercise group
Self directed exercise and psychosocial support group
Behavioral: Psychosocial support
- Overall Survival [ Time Frame: up to 5 years ]Overall survival will be measured from the time of randomization until death
- Disease Progression [ Time Frame: up to 5 years ]Time to disease progression will be measured from randomization until the first of the following: first CT or bone scan documenting disease progression, initiation of a new therapy for mPC (clinical progression), or first occurrence of a Symptomatic Skeletal Related Event (SSE).
- Symptomatic Skeletal Related Events (SSE) [ Time Frame: up to 5 years ]
Time to first occurrence of SSE will be defined as the time from randomization to documentation of any of the following (whichever occurs first) + 1 day:
- Use of external beam radiation therapy to relieve bone pain
- Occurrence of new symptomatic pathological bone fractures that may be vertebral or non-vertebral. Asymptomatic compression fractures detected by radiology review only will not be considered a SSE.
- Spinal cord compression
- Change in antineoplastic therapy to treat bone pain
- Surgical intervention to treat bone pain
- Opiate Use [ Time Frame: up to 5 years ]Opiate use will be assessed via BPI-SF, the medical record review at entry with a lead-in period (<28 days). The questionnaires will be administered every three cycles until month 24, and in month 36.
- Analgesic Use [ Time Frame: up to 5 years ]Analgesic use will be assessed via BPI-SF, the World Health Organisation (WHO) analgesic scale, and medical record review at entry with a lead-in period (<28 days). The WHO analgesic scale will be completed every three cycles (based on medical review) and questionnaires will be administered every three cycles until month 24, and in month 36.
- Biomarker analysis [ Time Frame: up to 5 years ]Inflammatory and cytokine systemic milieu
- Biomarker analysis [ Time Frame: up to 5 years ]Insulin/Glucose Metabolism
- Biomarker analysis [ Time Frame: up to 5 years ]Androgen biosynthesis
- Quality of Life [ Time Frame: up to 5 years ]Physical and emotional quality of life measured by the questionnaires- Functional Assessment of Cancer Therapy- Prostate (FACT-P), Functional assessment of Chronic Illness Therapy (FACIT-Fatigue), and EuroQOL Five Dimension Questionnaire (EQ5D) will be assessed every 3 cycles.
- Physical Function [ Time Frame: up to 5 years ]Physical function will be assessed using strength assessments (1RM), a cardiopulmonary exercise test (CPET) and a functional performance test (400m walk)
- Pain [ Time Frame: up to 5 years ]Pain will be assessed via questionnaire Brief Pain Inventory- short form (BPI-SF) and medical record review at entry with a lead-in period (<28 days) and repeated measures will occur every three cycles
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02730338
|Contact: Sam McKeownfirstname.lastname@example.org|
|Contact: Jennette Sison||+01 415 885 3692||Jennette.Sison@ucsf.edu|
|Study Chair:||Robert Newton||Edith Cowan University|
|Study Chair:||Fred Saad||Centre hospitalier de l'Université de Montréal (CHUM)|