Protocol Title:

A Phase III Trial of the Study of Endocrine Therapy Used as a Cytoreductive and Cytostatic Agent Prior to Radiation Therapy in Good Prognosis Locally Confined Adenocarcinoma of the Prostate

Protocol Status:

Closed

Protocol Number:

R 9408

Type of Cancer:

Prostate

Principal Investigator:

Danny Song, M.D.

Phase Number:

III

Summary:

This study opened October 31, 1998, and closed to accrual on June 27, 2002 with 370 patients entered. Two hundred fifty-four high-risk patients were randomized to Arms 2 and 3, while 116 low-risk patients were registered to the observation arm. Six patients were treated at Johns Hopkins. . All Patients have completed therapy, one patient is deceased. Of the 5 remaining patients, data is collected annually. These visits are standard of care for prostate cancer patients and include physical exam and PSA measurement. There have been no adverse events or unanticipated problems to subjects during the study.