NCT00480857

Salvage Radiation Therapy and Taxotere for PSA Failure After Radical Prostatectomy

Salvage Radiation Therapy and Docetaxel (Taxotere) for Biochemical Failure After Radical Prostatectomy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: University of Michigan Rogel Cancer Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to try to find out whether adding chemotherapy to the standard treatment for your stage of prostate cancer is more effective than the standard treatment by itself. The kind of treatment that most physicians would consider standard for this stage of prostate cancer is radiation therapy alone, possibly in combination with hormonal therapy. In this study, all patients will receive chemotherapy and radiation therapy. It is hoped that chemotherapy will be found to provide additional benefit, but chemotherapy has significant side effects. The use of chemotherapy is experimental in prostate cancer; it needs to be tested to determine if it is beneficial and to find out more about the side effects of the two different treatments. This study is to determine the effects, good and/or bad, of adding chemotherapy to radiation therapy as "salvage" treatment for recurrent prostate cancer after surgery.

Detailed description

There is no treatment proven more effective for clinically localized prostate cancer than radical prostatectomy. Nonetheless, approximately 30,000 men annually in the U.S. develop recurrence of their prostate cancer after prostatectomy. Radiation therapy is commonly utilized as attempted salvage treatment for patients who develop a rising PSA (Prostate Specific Antigen) after prostatectomy and have no evidence of metastatic disease. This study is designed to determine whether concurrent chemotherapy, weekly docetaxel, and daily radiation therapy will result in improved disease control and survival rates over those obtained with radiotherapy alone in the treatment of men with biochemical recurrence after radical prostatectomy.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Docetaxel (Taxotere)	Concurrent weekly docetaxel at 20mg/m2 with radiation therapy. Chemo dose may be held or reduced based on specific lab parameters.

Timeline

• Start date: 2007-03-01
• Primary completion: 2013-08-01
• Completion: 2014-07-01
• First posted: 2007-05-31
• Last updated: 2017-10-06
• Results posted: 2015-01-16

Locations

1 site across 1 country: United States