External Beam Radiation Therapy (EBRT) With or Without Hormonal Therapy in Prostate Cancer
Status:
Terminated
Trial end date:
2011-04-01
Target enrollment:
Participant gender:
Summary
Primary Objective:
- To assess the possible improvement in prostate specific antigen (PSA) outcome of short
course androgen suppression therapy in conjunction with dose-escalation intensity
modulated radiation therapy (IMRT), 3D conformal radiation therapy (3D-CRT), or proton
therapy over IMRT, 3D-CRT, or proton therapy alone in prostate cancer patients
traditionally considered at intermediate risk for PSA failure following conventional
local therapy. PSA failure will be the primary endpoint.
Secondary Objectives:
- To assess local control, freedom from distant metastasis, and overall survival.
- To study the impact of radiation therapy and/or hormone therapy on health-related
quality of life measures using the Expanded Prostate Cancer Index Composite-Short Form
12-American Urological Association Symptom Index (EPIC-SF12-AUASI:
http://roadrunner.cancer.med.umich.edu/epic/).
- To assess prognostic value of pretreatment serum testosterone as well as the decrease in
hemoglobin from neoadjuvant hormone therapy.
- To assess prognostic value of pretreatment biomarkers on subsequent post-treatment
clinical outcomes.