Radiation Therapy With or Without Antiandrogen Therapy in Treating Patients With Stage I or Stage II Prostate Cancer

Completed · Phase 3

Conditions studied: Prostate Cancer

In brief

RATIONALE: Radiation therapy (RT) uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using flutamide, goserelin, and leuprolide may fight prostate cancer by reducing the production of androgens. It is not yet known which regimen of antiandrogen therapy is most effective for prostate cancer. PURPOSE: Randomized phase III trial to study the effectiveness of radiation therapy with or without antiandrogen therapy in treating patients who have stage I or stage II prostate cancer.

Key facts

Study ID

NCT00002597

Run by

Radiation Therapy Oncology Group

People needed

2028

Starts

1994-10-01

Expected to finish

2018-05-14

Last updated by the study team

2018-06-14

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed locally confined adenocarcinoma of the prostate with primary tumors confined to the prostate, clinical stage T1b,1c, 2a or 2b.
• Negative nodes evaluated by imaging methods (classified in the study as NX) or by surgical sampling (classified in the study as N0).
• Karnofsky performance status ≥ 70.
• PSA is mandatory, must be ≤ 20)
• No prior hormonal therapy, radiation or chemotherapy.
• Prior finasteride for prostate hypertrophy allowed if discontinued at least 60 days prior to randomization.
• Prior testosterone administration allowed if at least 90 days elapsed since last administration.
• No evidence of distant metastasis or other synchronous primary. Patients with prior invasive malignancy who were disease free for at least 5 years could be eligible with pre-randomization approval by the study chairman.
• Treatment begins within 21 days after randomization.
• Patients signs a study-specific informed consent form.
• Alanine Aminotransferase (ALT) within 2x upper normal limits.

You may not qualify if…

• Stage T1a or ≥ T2c disease.
• Lymph node involvement (N1 - N3).
• Evidence of distant metastasis. (M1)
• PSA > 20.
• Radical surgery or cryosurgery for carcinoma of the prostate, previous irradiation, antiandrogen therapy or chemotherapy.
• Previous or concurrent cancers other than basal cell or squamous cell skin carcinoma.
• Patients with squamous cell carcinomas required to be NED (no evidence of disease) for a minimum of two years prior to study entry.
• Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up.
• Karnofsky performance status of < 70.

Where it is running

• Huntsville Hospital System — Huntsville, Alabama, United States
• Comprehensive Cancer Institute of Huntsville — Huntsville, Alabama, United States
• MBCCOP - Gulf Coast — Mobile, Alabama, United States
• Alabama Oncology, LLC — Montgomery, Alabama, United States
• Radiation Oncology Associates of West Alabama — Tuscaloosa, Alabama, United States
• Providence Alaska Medical Center — Anchorage, Alaska, United States
• Arizona Cancer Center — Tucson, Arizona, United States
• Mount Diablo Medical Center — Concord, California, United States
• Cancer Center and Beckman Research Institute, City of Hope — Duarte, California, United States
• California Cancer Center — Fresno, California, United States
• Saint Agnes Cancer Center — Fresno, California, United States
• Glendale Memorial Hospital and Health Center — Glendale, California, United States
• Sutter Health Western Division Cancer Research Group — Greenbrae, California, United States
• University of California San Diego Cancer Center — La Jolla, California, United States
• Loma Linda University Medical Center — Loma Linda, California, United States
• Veterans Affairs Medical Center - Long Beach — Long Beach, California, United States
• USC/Norris Comprehensive Cancer Center and Hospital — Los Angeles, California, United States
• Jonsson Comprehensive Cancer Center, UCLA — Los Angeles, California, United States
• CCOP - Bay Area Tumor Institute — Oakland, California, United States
• Cancer Care Center — Pomona, California, United States
• Radiation Oncology Center - Sacramento — Sacramento, California, United States
• Radiation Medical Group, Inc. — San Diego, California, United States
• UCSF Cancer Center and Cancer Research Institute — San Francisco, California, United States
• O'Connor Hospital — San Jose, California, United States
• University of Alabama at Birmingham Comprehensive Cancer Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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