Trial Information
A Pilot Study of Pre-Operative Conformal Radiotherapy in Patients With Radical Prostatectomy
Inclusion Criteria
- Histologically confirmed carcinoma of the prostate
- High risk localized disease defined as clinical T1 or T2 plus [ (i) Gleason ¡Ý7,
PSA>10 ng/ml and <35 ng/ml OR (ii) PSA >15 ng/ml and less <35 ng/ml (any Gleason) ]
- No evidence of pelvic lymph node metastases on CT scan within 4 months of surgery
- No evidence of distant metastases on bone scan within 4 months of surgery
- No contraindication to pelvic radiation therapy
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To document the feasibility of pre-operative conformal radiation therapy in patients undergoing radical prostatectomy for localized prostate cancer who are at high risk for having local extra-prostatic disease at time of surgery.
Principal Investigator
Padraig Warde, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Princess Margaret Hospital, Canada
Authority:
Canada: Ethics Review Committee
Study ID:
UHN REB 01-0483-C
NCT ID:
NCT00252447
Start Date:
May 2000
Completion Date:
March 2009
Related Keywords:
- Prostatic Neoplasm
- Neoplasms
- Prostatic Neoplasms