Status: Closed
Activation Date: 2007JUN15
Closing Date: 2011MAY13
Phase: III
Description: A Phase III Study of Active Surveillance Therapy Against Radical Treatment in Patients Diagnosed with Favourable Risk Prostate Cancer (START)
Eligibility: Histologically confirmed adenocarcinoma of the prostate that is negative for metastasis. Patient is a suitable candidate for radical prostatectomy or radiotherapy. No previous treatment for prostate cancer for greater than 6 months. Patient has been classified as favourable risk as defined by the following: clinical stage T1b, T1c, T2a or T2b, surgical Gleason score <= 6, PSA <= 10.0 ng/ml. For more information, please view our Patient Educational Video at the following web link: http://smaug/trials/start/start.html
Objective: To compare disease specific survival in patients with favourable risk prostate cancer treated with radical prostatectomy or radical radiotherapy at the time of initial diagnosis to active surveillance and selective intervention based on pre-specified biochemical, histological or clinical criteria.
Participation: Not limited
Lay Description: This study examines whether or not men with newly diagnosed cancer of the prostate should immediately undergo surgery or radiation therapy as opposed to actively monitoring the disease and treating only if the cancer gets worse. It is believed that many men suffer the side effects of radical treatments, when their cancer in fact has a very small chance of ever causing any problems. Currently, there are excellent, non-invasive tools for accurately monitoring prostate cancer progression, which may potentially be used to determine when and if radical therapy is required. For more information, please view our Patient Educational Video at the following web link: http://www.ctg.queensu.ca/trials/start/start.html
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Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
GENITO-URINARY | PR11 | 180 | 82 | 66 | 115 |
(Core size is 0.6 mm)
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Fluid SamplesDisease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
GENITO-URINARY | PR11 | 180 | 1 | 8 |
Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
GENITO-URINARY | PR11 | 180 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 0 |