NCT01603420

External Beam Radiation With or Without Chemotherapy to Treat High Risk Prostate Cancer

Phase 2/3 Study of Dose-escalated External Beam Radiation Therapy With or Without Chemotherapy for High Risk Adenocarcinoma of the Prostate

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Proton Collaborative Group · Network
• Sex: Male
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Luteinizing hormone-releasing hormone (LHRH)	Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin.
DRUG	Docetaxel	Docetaxel 20mg/m2 IV every 7 days x 8 weeks.
OTHER	Conformal Radiation Therapy (RT)	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).

Timeline

• Start date: 2012-07-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2012-05-22
• Last updated: 2016-03-14
• Results posted: 2015-08-31

Locations

3 sites across 1 country: United States