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A PHASE III TRIAL EMPLOYING CONFORMAL PHOTONS WITH PROTON BOOST IN EARLY STAGE PROSTATE CANCER: CONVENTIONAL DOSE COMPARED TO HIGH DOSE IRRADIATION


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

Thank you

Trial Information

A PHASE III TRIAL EMPLOYING CONFORMAL PHOTONS WITH PROTON BOOST IN EARLY STAGE PROSTATE CANCER: CONVENTIONAL DOSE COMPARED TO HIGH DOSE IRRADIATION


OBJECTIVES: I. Determine whether high-dose radiotherapy using conformal photons with a
proton boost produces a 20% increase in the proportion of Stage I/II prostate cancer free
from local failure and biochemical relapse at 5 years when compared to results of
conventional-dose radiotherapy. II. Determine whether high-dose radiotherapy produces a 33%
reduction in the cumulative incidence of a rising PSA (second hormone failure) following
hormone therapy given at the time of first PSA/clinical failure when compared with
conventional-dose radiotherapy. IV. Assess the relative rectal, bladder, and sexual
morbidity of conformal photon doses of 70.2 and 79.2 Gy in these patients. V. Collect, in a
prospective manner, paraffin biopsy blocks for subsequent analysis of emerging molecular
pathologic predictors of outcome in three patients.

OUTLINE: Randomized study. Arm I: Radiotherapy. Boost to the prostate using high-LET protons
followed by irradiation of the prostate, periprostatic tissues, and seminal vesicles using
conformal photons with energies greater than 6 MV. Conventional dose. Arm II: Radiotherapy.
As in Arm I. High dose.

PROJECTED ACCRUAL: There will be 390 patients accrued into this study over 3 years. An
additional 3.5 years will be required for follow-up.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate Primary
tumor confined to prostate TNM clinical Stages T1b-c or T2a-b No T1a No T1b-c tumor with
Gleason grade 1-2/5 No Gleason grade 1-2/5 and PSA less than 4 ng/mL Nodes negative on
imaging (Nx) or by surgical sampling (N0) PSA no greater than 15 ng/mL Treatment must
begin within 28 days after randomization

PATIENT CHARACTERISTICS: Age: Any age Performance status: Karnofsky 70%-100% Life
expectancy: Greater than 10 years Other: No major medical or psychiatric illness that
precludes protocol entry No prior or concurrent second malignancy within 5 years except
basal cell skin cancer

PRIOR CONCURRENT THERAPY: No prior treatment for prostate cancer

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Anthony L. Zietman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Federal Government

Study ID:

CDR0000064503

NCT ID:

NCT00002703

Start Date:

January 1996

Completion Date:

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage I prostate cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • Prostatic Neoplasms

Name

Location

Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
Loma Linda University Medical CenterLoma Linda, California  92354