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Completed

NCT Number: NCT00548600

Radical Radiotherapy by External Beam Radiation Versus Radical Radiotherapy With Temporary Iridium Implant Plus External Beam Radiation in 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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

Up to 75 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Iridium Implant

Procedure

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.

Standard external beam irradiation

Radiation

Standard external beam irradiation at a dose of 6400 cGy in 32 fractions over 6 and a half weeks will be administered.

Primary outcomes

  1. Rate of local control as determined by biopsy at 18 months

    Time frame: 18-months

Secondary outcomes

  1. Distant metastasis

    Time frame: survival

  2. Overall mortality

    Time frame: survival

  3. Mortality due to prostate cancer

    Time frame: survival

  4. Local complications of radiation

    Time frame: 2-5 years

Sponsors and collaborators

Lead sponsor

Ontario Clinical Oncology Group (OCOG)

Other

Registry information

Official study 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

Important dates

Study start
1992
Study completion
2006
First posted
Oct 24, 2007
Registry last updated
Oct 24, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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