Radiation Therapy in Treating Patients With Stage I or Stage II Prostate Cancer
|ClinicalTrials.gov Identifier: NCT00002703|
Recruitment Status : Completed
First Posted : September 1, 2004
Last Update Posted : November 6, 2013
RATIONALE: Radiation therapy uses high energy x-rays to damage tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of conventional radiation therapy with high-dose radiation therapy in treating men with stage I or stage II prostate cancer.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Radiation: high-LET heavy ion therapy Radiation: low-LET photon therapy||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||390 participants|
|Official Title:||A PHASE III TRIAL EMPLOYING CONFORMAL PHOTONS WITH PROTON BOOST IN EARLY STAGE PROSTATE CANCER: CONVENTIONAL DOSE COMPARED TO HIGH DOSE IRRADIATION|
|Study Start Date :||January 1996|
|Actual Study Completion Date :||September 2005|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002703
|United States, California|
|Loma Linda University Medical Center|
|Loma Linda, California, United States, 92354|
|United States, Massachusetts|
|Massachusetts General Hospital Cancer Center|
|Boston, Massachusetts, United States, 02114|
|Study Chair:||Anthony L. Zietman, MD||Massachusetts General Hospital|