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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00548600

Enrollment

112

Registered

2007-10-24

Start date

1992-05-31

Completion date

2006-09-30

Last updated

2007-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Prostate Cancer, Iridium, Implant, Radiotherapy

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.

Interventions

PROCEDUREIridium 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.

RADIATIONStandard 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

No minimum to 75 Years

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

Design outcomes

Primary

Measure	Time frame
Rate of local control as determined by biopsy at 18 months	18-months

Secondary

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026