ProSTART
Disease site: Urological
Treatment Modality: Radiotherapy
Status: In active follow-up
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 2130 patients, and the primary endpoint will be disease specific survival.
Chief Investigator: | Dr Chris Parker |
Sponsor: | Institute of Cancer Research (UK representative sponsor) |
Source of funding: | Cancer Research UK |
ISRCTN: | As this is a Canadian Study it is registered on the NCT trials database no. 00499174 |
ProSTART Trial Website for Downloading Patient Case Report Forms
This page contains links to the current versions of ProSTART CRF’s to be completed for each patient taking part in the trial.
Each CRF is password protected. If you are an open centre, you will have been provided with a password at site initiation. For password enquiries, please contact the Trial Coordinator at: prostart-icrctsu@icr.ac.uk
CRFs can be downloaded and saved. Notification of amended versions will be emailed to the primary centre contact by the Trial Coordinator, and the new versions with be put on this webpage.
ProSTART Patient Case Report Forms
Eligibility Checklist | Download UK eligibility checklist 1.0 20080218 (pdf) (80 KB) |
Form 1:Initial Evaluation | Download pr11-Form1-2009APR09 (pdf) (123 KB) |
Form 4: Radical Intervention Report | |
Form 5AS: Active Surveillance Report | |
Form 5: Follow-Up After Radical Intervention Report | |
Form 5S: Follow-Up After Distant Metastasis Report | |
Form 5M: Minimal Follow-Up Report – US | |
Form 6: Final Report | |
Form 9: Progressive Disease Report | |
SAE Form | |
Patient Specific Radiotherapy Questionnaire for High Dose Rate Brachytherapy | Download pr11-HDR-E-FillableForm-2006OCT31 (word doc) (123 KB) |
Patient Specific Radiotherapy Questionnaire for Seed Brachytherapy | Download pr11-Bracytherapy-E-FillableForm-2006OCT31 (word doc) (202 KB) |
Patient Specific Radiotherapy Questionnaire for Intensity Modulated Radiotherapy | Download pr11-IMRT-E-FillableForm-2006OCT31 (word doc) (228 KB) |
Patient Specific Radiotherapy Questionnaire for 3D Conformal Radiotherapy | Download pr11-3D-CRT-E-FillableForm-2006OCT31 (word doc) (171 KB) |