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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.
Information provided by:
Ontario Clinical Oncology Group (OCOG) Identifier:
First received: October 22, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted
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
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:

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.


Ages Eligible for Study:   up to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00548600

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

Publications: Identifier: NCT00548600     History of Changes
Other Study ID Numbers: OCOG-1992-Iridium
Study First Received: October 22, 2007
Last Updated: October 22, 2007

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

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases processed this record on April 28, 2017