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


Phase 3
N/A
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

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


In this trial, men with intermediate risk prostate cancer will be randomized to a shorter
course of radiotherapy (6000cGy in 20 fractions over 4 weeks-hypofractionated) or treatment
with a conventional fractionation course (7800cGy in 39 fractions over 8 weeks-standard).
Three-dimensional conformal radiation treatment techniques, including intensity modulated
radiotherapy will be used for both hypofractionated and standard treatments to avoid normal
tissue exposure to radiation and minimize the risk of acute and late treatment related
toxicity. The primary outcome measure is biochemical (PSA) failure defined by the ASTRO
consensus criteria. Secondary outcomes include biochemical-clinical failure (BCF), mortality
from cancer, toxicity and health-related quality of life. It is planned to recruit 1204
patients to the study. If the safety and efficacy of the shorter course are demonstrated,
then its adoption would reduce the social, emotional and economic burden of treatment for
patients and their families.


Inclusion Criteria:



1. Histologic diagnosis of carcinoma of the prostate within 6 months of entry without
evidence of metastatic disease to the lymph nodes, bone or lung;

2. Intermediate risk prostate cancer (that is, T1-2a, Gleason score <6, PSA 10.1-20.0
ng/ml; T2b-c Gleason <6, PSA ≤ 20.0 ng/ml; T1-2, Gleason 7, PSA ≤ 20.0 ng/ml).

Exclusion Criteria:

1. Histologic diagnosis of carcinoma of the prostate more than six months prior to study
entry;

2. Previous therapy for carcinoma of the prostate other than biopsy or transurethral
resection;

3. Patients previously on more than 12 weeks of hormone therapy for treatment of their
prostate cancer;

4. Any other active malignancy (untreated, progressive or recurrent), except for
non-melanoma skin cancer. Any inactive malignancy diagnosed within 5 years of entry,
except for non-melanoma skin cancer;

5. Treatment plan cannot meet dose constraints for the hypofractionation arm of the
trial;

6. Previous pelvic radiotherapy;

7. Inflammatory bowel disease.

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:

Biochemical (PSA) Failure

Outcome Time Frame:

five years

Safety Issue:

No

Principal Investigator

Charles Catton, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Princess Margaret Hospital, Canada

Authority:

Canada: Health Canada

Study ID:

OCOG-2005-PROFIT

NCT ID:

NCT00304759

Start Date:

May 2006

Completion Date:

June 2020

Related Keywords:

  • Prostate Cancer
  • prostate cancer
  • localized prostate cancer
  • intermediate risk
  • prostate specific antigen
  • PSA
  • radiation fractionation
  • shorter schedule
  • quality of life
  • Prostatic Neoplasms

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