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Supervised high intensity aerobic and resistance exercise tapering to self management with psychosocial support

Self directed exercise and psychosocial support group

High intensity aerobic and resistance training

Psychosocial support

Robert Newton

Fred Saad

To determine if supervised high intensity aerobic and resistance training increases overall survival compared to self-directed exercise in patients with metastatic prostate cancer.

INTense ExeRcise for surviVAL Among Men With Metastatic Prostate Cancer (INTERVAL - GAP4)

INTense ExeRcise for surviVAL Among Men With Metastatic Prostate Cancer (INTERVAL - GAP4): A Multicentre, Randomised, Controlled, Phase III Study

Overall survival will be measured from the time of randomization until death

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).

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 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 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.

Inflammatory and cytokine systemic milieu

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 will be assessed using strength assessments (1RM), a cardiopulmonary exercise test (CPET) and a functional performance test (400m walk)

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
INTense ExeRcise for surviVAL Among Men With Metastatic Prostate Cancer (INTERVAL - GAP4)	NCT02730338	Metastatic Pros...	High intensity ... Psychosocial su...	18 Years -	Movember Foundation
INTense ExeRcise for surviVAL Among Men With Metastatic Prostate Cancer (INTERVAL - GAP4)	NCT02730338	Metastatic Pros...	High intensity ... Psychosocial su...	18 Years -	Movember Foundation
INTense ExeRcise for surviVAL Among Men With Metastatic Prostate Cancer (INTERVAL - GAP4)	NCT02730338	Metastatic Pros...	High intensity ... Psychosocial su...	18 Years -	Movember Foundation

Spots Global Cancer Trial Database for high intensity aerobic and resistance training