Radical Radiotherapy by External Beam Radiation Versus Radical Radiotherapy With Temporary Iridium Implant Plus External Beam Radiation in Carcinoma of the Prostate
Phase 3
Completed
- Conditions
- Prostate Cancer
- Registration Number
- NCT00548600
- Lead Sponsor
- Ontario Clinical Oncology Group (OCOG)
- Brief Summary
The specific objective of this study is to compare the relative efficacy of the combination of a temporary iridium implant plus external beam irradiation versus standard external beam irradiation alone in patients with Stage B2 and C prostatic carcinoma. Benefit will be assessed in terms of local recurrence, survival, and toxicity.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 112
Inclusion Criteria
- All patients must have histologically proven adenocarcinoma of the prostate
- The primary tumour should be staged clinically B2 or C as classified by A.J.C. Staging System
Exclusion Criteria
- Patients requiring transurethral prostatectomy (TURP) prior to diagnosis
- Presence of metastases identified by bone scan, chest x-ray or CT scan of the abdomen and pelvis, or staging lymphadenectomy
- Karnofsky performance status less than 80
- Inadequate laboratory results: i.e. Hb < 12 gm/litre, WBC < 3.5 x 10 per litre, platelets < 100 x 10/litre, urea > 13 mmol/litre, creatinine > 220 mmol/litre
- Unfit for surgery for other medical reasons
- Age above 75 years
- Failure to provide written informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Rate of local control as determined by biopsy at 18 months 18-months
- Secondary Outcome Measures
Name Time Method Distant metastasis survival Overall mortality survival Mortality due to prostate cancer survival Local complications of radiation 2-5 years
Trial Locations
- Locations (1)
Juravinski Cancer Centre
🇨🇦Hamilton, Ontario, Canada
Juravinski Cancer Centre🇨🇦Hamilton, Ontario, Canada