INTERVAL - MCRPC v3.0
Research type
Research Study
Full title
INTense Exercise foR surVivAL among men with Metastatic Castrate-Resistant Prostate Cancer (INTERVAL - MCRPC): A Multicenter, Randomized, Controlled, Phase III Study
IRAS ID
201101
Contact name
Sarah Rudman
Contact email
Sponsor organisation
Guy’s and St Thomas’ NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 8 months, 11 days
Research summary
The research proposal, known as GAP 4 or INTERVAL-MCRPC, has been funded and developed by Movember Foundation, in view to include 19 research sites worldwide. In the UK, six research sites will be involved, which are; Guy's and St. Thomas Hospital (London), Belfast, Bristol, Glasgow, Surrey and Oxford. Guy's and St. Thomas Hospital is acting as the sponsor site for the UK.
INTERVAL- MCRPC is a randomised, controlled, Phase III trial to evaluate impact of high intensity aerobic and resistance training, including behavioural support, on survival and quality of life (QOL) in advanced prostate cancer (PCa) patients. The study may lead to potential practice-changing research for men with PCa, where new guidelines for exercise as therapeutic modality may be created. This is a unique opportunity to demonstrate exercise as 'medicine' on patient survival.
The study will be conducted in hospital clinics where the treating physician can assess the patients before enrolment.
866 men with histologically confirmed metastatic castrate-resistant PCa will be divided into two groups; (i) intervention group will receive high intensity aerobic and resistance training accompanied with psychosocial support and (ii) the control group will receive psychosocial support alone. Each group will undergo exersice assessments, metabolic biomarker assessments and QoL assessments during different time points. The intervention group will be required to do additional 12-months supervised exercise classes (in cycles 0, 1-8, 9-11) and 12-months self-managed exercise programme. All subjects will be involved in the study for 36 months after randomisation, providing they do not withdraw.REC name
London - Dulwich Research Ethics Committee
REC reference
17/LO/0417
Date of REC Opinion
8 Jun 2017
REC opinion
Further Information Favourable Opinion