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

October 22, 2007
October 22, 2007
May 1992
Not Provided
Rate of local control as determined by biopsy at 18 months [ Time Frame: 18-months ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
  • 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.
  • Experimental: 1
    Iridium implant plus external beam irradiation
    Intervention: Procedure: Iridium Implant
  • Active Comparator: 2
    Standard external beam irradiation alone
    Intervention: Radiation: Standard external beam irradiation
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
112
September 2006
Not Provided

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
Male
up to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00548600
OCOG-1992-Iridium
No
Not Provided
Ontario Clinical Oncology Group (OCOG)
Not Provided
Study Chair: Jinka Sathya, MD Juravinski Cancer Centre
Ontario Clinical Oncology Group (OCOG)
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP