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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


Phase 3
N/A
75 Years
Not Enrolling
Male
Prostate Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Rate of local control as determined by biopsy at 18 months

Outcome Time Frame:

18-months

Principal Investigator

Jinka Sathya, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Juravinski Cancer Centre

Authority:

Canada: Health Canada

Study ID:

OCOG-1992-Iridium

NCT ID:

NCT00548600

Start Date:

May 1992

Completion Date:

September 2006

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • Iridium
  • Implant
  • Radiotherapy
  • Carcinoma
  • Prostatic Neoplasms

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