Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
University of Michigan Cancer Center Sanofi-Aventis |
---|---|
Information provided by: | University of Michigan Cancer Center |
ClinicalTrials.gov Identifier: | NCT00480857 |
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.
Condition | Intervention | Phase |
---|---|---|
Prostate Cancer |
Drug: Docetaxel (Taxotere) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Salvage Radiation Therapy and Docetaxel (Taxotere) for Biochemical Failure After Radical Prostatectomy |
Estimated Enrollment: | 44 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | May 2021 |
Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
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 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
This must be demonstrated by an increase of at least 0.1 ng/mL between two consecutive measurements, both obtained after prostatectomy. The most recent measurement (within 28 days of registration) must be 0.3 ng/mL or greater.
Hematologic Criteria: CBC/differential obtained within 28 days prior to registration on study, with adequate bone marrow function defined as follows:
Hepatic Criteria within 28 days prior to registration:
Exclusion Criteria:
Severe, active co-morbidity, defined as follows, active co-morbidity, defined as follows:
Contact: Kristin Brierley, B.S. | 734-936-9439 | kbrier@umich.edu |
United States, Michigan | |
University of Michigan | Recruiting |
Ann Arbor, Michigan, United States, 48109-5010 |
Principal Investigator: | Howard M. Sandler, M.D. | University of Michigan |
Responsible Party: | University of Michigan Cancer Center ( Howard Sandler, M.D. ) |
Study ID Numbers: | UMCC 2006.066 |
Study First Received: | May 29, 2007 |
Last Updated: | July 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00480857 History of Changes |
Health Authority: | United States: Institutional Review Board |
Prostate Radiation |
Docetaxel Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Docetaxel Neoplasms Neoplasms by Site Prostatic Diseases Genital Neoplasms, Male Antineoplastic Agents |
Therapeutic Uses Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms Pharmacologic Actions |