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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00548600
• Other study ID #: OCOG-1992-Iridium
• Status: Completed
• Phase: Phase 3
• First received: October 22, 2007
• Last updated: October 22, 2007
• Start date: May 1992
• Est. completion date: September 2006

Study information

• Verified date: October 2007
• Source: Ontario Clinical Oncology Group (OCOG)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Canada	Juravinski Cancer Centre	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ontario Clinical Oncology Group (OCOG)

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Sathya JR, Davis IR, Julian JA, Guo Q, Daya D, Dayes IS, Lukka HR, Levine M. Randomized trial comparing iridium implant plus external-beam radiation therapy with external-beam radiation therapy alone in node-negative locally advanced cancer of the prostate. J Clin Oncol. 2005 Feb 20;23(6):1192-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of local control as determined by biopsy at 18 months		18-months
Secondary	Distant metastasis		survival
Secondary	Overall mortality		survival
Secondary	Mortality due to prostate cancer		survival
Secondary	Local complications of radiation		2-5 years