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

Ontario Clinical Oncology Group (OCOG)

Status and phase

Completed

Phase 3

Conditions

Prostate Cancer

Treatments

Procedure: Iridium Implant

Radiation: Standard external beam irradiation

Study type

Interventional

Funder types

Other

Identifiers

NCT00548600

OCOG-1992-Iridium

Details and patient eligibility

About

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.

Enrollment

112 patients

Sex

Male

Ages

Under 75 years old

Volunteers

No Healthy Volunteers

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