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

NCT00548600 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2007-10-24

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Iridium Implant

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.

RADIATION

Standard external beam irradiation

Standard external beam irradiation at a dose of 6400 cGy in 32 fractions over 6 and a half weeks will be administered.

Sponsors & Collaborators

  • Ontario Clinical Oncology Group (OCOG)

    lead OTHER

Principal Investigators

  • Jinka Sathya, MD · Juravinski Cancer Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1992-05-31
Completion
2006-09-30

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00548600 on ClinicalTrials.gov