A Pilot Study for a phase III Clinical Trial in Patients with Favourable Risk Prostate Cancer Comparing Active Surveillance Therapy Against Radical Treatment
Disease site: Urological Prostate cancer
Treatment modality: Radiotherapy
ProSTART is a pilot study for an international phase III randomised parallel group trial in patients with favourable risk prostate cancer, comparing active surveillance therapy against radical treatment (surgery or radiotherapy). The study was developed by the National Cancer Institute of Canada, and the pilot Phase is being carried out in the UK, Canada and the USA.
The primary objective of the pilot study is to determine recruitment rate and assess feasibility of a randomised Phase III clinical trial. It is expected that 20–40 patients will be recruited to the pilot study over a 2 year period. The main trial will aim to recruit 2,130 patients, and the primary endpoint will be disease specific survival.
Chief Investigator: Dr Chris Parker, The Royal Marsden NHS Foundation Trust
ICR-CTSU Scientific Lead: Dr Emma Hall
Trial management contact: Rebecca Lewis - Senior Trial Manager, [email protected]
ISRCTN: As this is a Canadian Study it is registered on the NCT trials database no. 00499174
Sponsor: The Institute of Cancer Research (UK representative sponsor)
Funding: Cancer Research UK (CRUK/07/03)
Further information on the ProSTART trial may be found on the following site:
Patient friendly information on the ProSTART trial at CancerHelp UK