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Clinical Trials/NCT00548600
NCT00548600
Completed
Phase 3

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

Ontario Clinical Oncology Group (OCOG)1 site in 1 country112 target enrollmentMay 1992
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ConditionsProstate Cancer

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
Ontario Clinical Oncology Group (OCOG)
Enrollment
112
Locations
1
Primary Endpoint
Rate of local control as determined by biopsy at 18 months
Status
Completed
Last Updated
18 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 1992
End Date
September 2006
Last Updated
18 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Sponsor
Ontario Clinical Oncology Group (OCOG)

Eligibility 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

Outcomes

Primary Outcomes

Rate of local control as determined by biopsy at 18 months

Time Frame: 18-months

Secondary Outcomes

  • Mortality due to prostate cancer(survival)
  • Distant metastasis(survival)
  • Overall mortality(survival)
  • Local complications of radiation(2-5 years)

Study Sites (1)

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