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

This study has been completed.
Sponsor:
Information provided by:
Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier:
NCT00548600
First received: October 22, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
 Procedure: Iridium Implant
Radiation: Standard external beam irradiation
 Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ontario Clinical Oncology Group (OCOG):

Primary Outcome Measures:
  • Rate of local control as determined by biopsy at 18 months [ Time Frame: 18-months ]

Secondary Outcome Measures:
  • Distant metastasis [ Time Frame: survival ]
  • Overall mortality [ Time Frame: survival ]
  • Mortality due to prostate cancer [ Time Frame: survival ]
  • Local complications of radiation [ Time Frame: 2-5 years ]

Enrollment: 112
Study Start Date: May 1992
Study Completion Date: September 2006
Arms Assigned Interventions
Experimental: 1
Iridium implant plus external beam irradiation
 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.
Active Comparator: 2
Standard external beam irradiation alone
 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.

  Eligibility

Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00548600

Locations
Canada, Ontario
Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Sponsors and Collaborators
Ontario Clinical Oncology Group (OCOG)
Investigators
Study Chair: Jinka Sathya, MD Juravinski Cancer Centre
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00548600     History of Changes
Other Study ID Numbers: OCOG-1992-Iridium
Study First Received: October 22, 2007
Last Updated: October 22, 2007
Health Authority: Canada: Health Canada

Keywords provided by Ontario Clinical Oncology Group (OCOG):
Prostate Cancer
Iridium
Implant
Radiotherapy

Additional relevant MeSH terms:
Carcinoma
Prostatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on June 18, 2013