Radical Radiotherapy by External Beam Radiation Versus Radical Radiotherapy With Temporary Iridium Implant Plus External Beam Radiation in Carcinoma of the Prostate

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Clinical Trial Comparing Radical Radiotherapy by External Beam Radiation Versus Radical Radiotherapy Using a Combination of a Temporaory Iridium Implant Plus External Beam Radiation in Surgically Staged B2 and C Carcinoma of the Prostate

Conditions
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Prostate Cancer

Intervention / Treatment
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* Procedure: Iridium Implant
* Radiation: Standard external beam irradiation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Iridium implant plus external beam irradiation | Procedure: Iridium Implant<br>* Temporary iridium implant of the prostate will be done and a dose of 3000 cGy will be delivered in the next 48-72 hours. Two weeks later 20 fractions of external beam radiation at a dose of 4000 cGy will be administered over a period of 4 weeks.<br>|
| Active Comparator: 2<br>Standard external beam irradiation alone | Radiation: Standard external beam irradiation<br>* Standard external beam irradiation at a dose of 6400 cGy in 32 fractions over 6 and a half weeks will be administered.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of local control as determined by biopsy at 18 months |  | 18-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distant metastasis |  | survival | 
| Overall mortality |  | survival | 
| Mortality due to prostate cancer |  | survival | 
| Local complications of radiation |  | 2-5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate Cancer, Iridium, Implant, Radiotherapy