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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

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

Download pr11-Form4-2009APR09 (pdf) (43 KB)

Form 5AS: Active Surveillance Report 

Download pr11-Form5AS-2009APR09 (pdf) (59 KB)

Form 5: Follow-Up After Radical Intervention Report

Download pr11-Form5-2009APR09 (pdf) (55 KB)

Form 5S: Follow-Up After Distant Metastasis Report

Download pr11-Form5S-2009APR09 (pdf) (46 KB)

Form 5M: Minimal Follow-Up Report – US

Download pr11_Form5M_2009APR09(pdf) (26 KB)

Form 6: Final Report 

Download pr11-Form6-2009APR09 (pdf) (48 KB)

Form 9: Progressive Disease Report

Download pr11-Form9-2009APR09 (pdf) (21 KB)

SAE Form

Download pr11-SAE-form-2007aug31 (pdf) (34 KB)

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)

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Trials by disease site:

  • Breast Cancer Clinical Trials
  • Other Cancer Clinical Trials
  • Urological Cancer Clinical Trials
  • Head & Neck Cancer Clinical Trials
  • Melanoma Clinical Trials

Trials by treatment modality:

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Urological Clinical Trials

Open to recruitment

  • 111 Trial
  • BOXIT
  • LopeRA
  • PIVOTAL

In set-up

  • POUT

In active follow-up

  • BC2001
  • CHHiP
  • Intercontinental
  • Penile TPF
  • ProSTART
  • SPARE


Last updated: 01 December 2011

The Royal Marsden - NHS foundation trust Cancer Research UK
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