Overview

Radiation Therapy and Hormone Therapy in Treating Patients With Prostate Cancer

Status:
Completed
Trial end date:
2016-12-01
Target enrollment:
0
Participant gender:
Male
Summary
RATIONALE: Radiation therapy uses high energy x-rays to damage tumor cells. Hormone therapy combined with radiation therapy may be a more effective treatment for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of four different combinations of radiation and hormone therapy in treating patients with prostate cancer.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Radiation Therapy Oncology Group
Collaborator:
National Cancer Institute (NCI)
Treatments:
Flutamide
Goserelin
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate Any stage
with an estimated risk of node involvement at least 15% (and therefore at significant risk
for local and/or systemic failure) based on pretreatment PSA and Gleason score (GS), e.g.:
GS of 7 and PSA greater than 7.5 ng/mL GS of 6 and PSA greater than 22.5 ng/mL GS of 5 and
PSA greater than 37.5 ng/mL PSA greater than 4 and less than 100 ng/mL Highest pretreatment
value determined by a monoclonal assay that has a normal range of 0-4 ng/mL PSA measured by
polyclonal assay (e.g., Yang) that has a normal range of 0-2.5 ng/mL may need to be divided
by a conversion factor of approximately 1.5 GS determination required prior to entry No
distant metastases No biopsy proven lymph node involvement Ineligible for protocol
RTOG-9408 (clinical stages T2c-T4 with GS of 6 or higher are eligible for this study)

PATIENT CHARACTERISTICS: Age: Any age Performance status: Karnofsky 70-100% Hematopoietic:
Not specified Hepatic: Liver function tests no greater than 1.2 times normal Renal: Not
specified Other: No major medical or psychiatric illness that would prevent completion of
treatment or interfere with follow-up No second malignancy within 5 years except
superficial nonmelanomatous skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy Endocrine therapy: At least 90 days since testosterone At least 60 days since
finasteride Radiotherapy: No prior radiotherapy Surgery: No more than 60 days since
surgical staging No radical surgery or cryosurgery