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
• Interventions: Procedure: Iridium Implant; Radiation: Standard external beam irradiation

• 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

Study Timeline

• Study Start: 1992-05
• Study Completion: 2006-09
• Status Verified: 2007-10
• Study First Submitted: 2007-10-22
• Study First Submitted QC: 2007-10-22
• Last Update Submitted: 2007-10-22
• Study First Posted: 2007-10-24
• Last Update Posted: 2007-10-24

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

Arm && Interventions

Group	Intervention	Description
1	Iridium Implant	Iridium implant plus external beam irradiation
2	Standard external beam irradiation	Standard external beam irradiation alone

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
Overall mortality	survival
Mortality due to prostate cancer	survival
Distant metastasis	survival
Local complications of radiation	2-5 years

Trial Locations

Locations (1)

Juravinski Cancer Centre; 🇨🇦 Hamilton, Ontario, Canada