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A Randomized Trial of a Shorter Radiation Fractionation Schedule for the Treatment of Localized Prostate Cancer

Phase 3
Not Enrolling
Prostate Cancer

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Trial Information

A Randomized Trial of a Shorter Radiation Fractionation Schedule for the Treatment of Localized Prostate Cancer

To compare the efficacy of a shorter radiation fractionation schedule to the prostate (5250
cGy/20 fractions over 28 days) with a conventional schedule (6600 cGy/33 fractions over 45
days) in men receiving radiotherapy for Stage T1a moderately or poorly differentiated, or
T1b, T1c, or T2 prostate cancer. The primary outcome is local control in the prostate and
secondary outcomes include toxicity, disease free survival, survival, quality of life and

Inclusion Criteria:

- histologic diagnosis of adenocarcinoma of the prostate with no evidence of metastatic
disease to the nodes, bone or lung

- stage T1a moderately or poorly differentiated, T1b, T1c or T2 by the current UICC-TNM

Exclusion Criteria:

- PSA > 40 mcg/L

- previous therapy for carcinoma of the prostate other than biopsy or TURP, including
patients previously on hormone therapy for treatment of their prostate cancer

- prior or active malignancy other than non-melanoma skin cancer; or colon or thyroid
cancer treated a minimum of five years prior to study entry and presumed cured

- simulated volume exceeds 1000 cm3

- previous pelvic radiotherapy

- inflammatory bowel disease

- serious non-malignant disease which would preclude radiotherapy or surgical biopsy

- geographic inaccessibility for follow-up

- psychiatric or addictive disorder which would preclude obtaining informed consent or
adherence to protocol

- unable to commence radiation therapy within 26 weeks of the date of last prostatic

- failure to give informed consent to participate in the study

Type of Study:


Study Design:

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

Outcome Measure:

time to PSA failure

Outcome Time Frame:

10 years

Safety Issue:


Principal Investigator

Himu Lukka, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Juravinski Cancer Centre


Canada: Health Canada

Study ID:




Start Date:

March 1995

Completion Date:

December 2009

Related Keywords:

  • Prostate Cancer
  • prostate cancer
  • prostate specific antigen
  • PSA
  • radiation fractionation
  • Prostatic Neoplasms