Conditions: Prostate Cancer
Keywords: prostate cancer radiation proton chemotherapy high risk
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 2
Healthy volunteers: no

Brief summary:
The purpose of this study is to compare the effects on prostate cancer using radiation therapy with or without chemotherapy.

Detailed description:
The recommended treatment for a high risk prostate cancer consists of a combination of radiation therapy and androgen suppression for 2-3 years. Recent studies have shown a survival advantage for chemotherapy for prostate cancer. Chemotherapy has already been successfully integrated in the treatment of other cancer types and is our belief that chemotherapy will prove to be beneficial for patients with high risk prostate cancer. However, a clinical study is necessary to compare the results good or bad of chemotherapy with radiation therapy.

Arms:
arm 1: Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression). arm 2: Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).

Interventions: intervention 1: Luteinizing hormone-releasing hormone (LHRH) intervention 2: Docetaxel intervention 3: Conformal Radiation Therapy (RT)
Intervention descriptions: intervention 1: Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin. intervention 2: Docetaxel 20mg/m2 IV every 7 days x 8 weeks. intervention 3: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy).

Protocol document: