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Sponsors and Collaborators: |
Norris Comprehensive Cancer Center U.S. Army Medical Research and Materiel Command |
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Information provided by: | Norris Comprehensive Cancer Center |
ClinicalTrials.gov Identifier: | NCT00669162 |
Following a radical prostatectomy and lymph node sampling, eligible patients will undergo adjuvant radiation therapy, concurrent weekly docetaxel chemotherapy , and hormonal therapy (Casodex daily and Zoladex every 3 months for 2 times or Lupron 22.5 mg im every 3 months for 2 times).
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: Docetaxel Radiation: conformal radiation therapy Drug: Casodex , Zoladex, Lupron |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I/II Trial of Adjuvant 3-D Conformal Radiation Therapy, Hormonal Therapy and Concurrent Docetaxel for High Risk Pathologic T2-T3N0M0 Prostate Cancer |
Estimated Enrollment: | 42 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | September 2011 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
To determine the safety and feasibility of combining weekly docetaxel with adjuvant 3-D conformal radiation therapy and hormonal therapy in men with high risk pathologic T2-3N0M0 prostate cancer after a radical prostatectomy.
To obtain preliminary information regarding the efficacy of combining weekly docetaxel with adjuvant 3-D conformal radiation therapy and hormonal therapy in men with high risk pathologic T2-3N0M0 prostate cancer by determining PSA failure free survival.
To assess the expression of molecular markers, such as Ki-67, bcl-2, bax, bcl-xL, bcl-2/bax ratio, apoptotic index, PAR1, chromogranin A, serotonin, and synaptophysin in the radical prostatectomy specimens and to explore the possible association with PSA failure free survival.
To assess baseline and longitudinal changes in health-related quality of life outcomes during and after therapy (at 3, 6, 12 and 24 months
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Status post radical prostatectomy with sampling of the pelvic lymph nodes with histologically confirmed adenocarcinoma of the prostate, with at least 1 of 3 disease criteria which must be met as indicated below:
Exclusion Criteria:
Contact: Linda Bailey-Theders, RN | 323-865-3071 | Bailey-Theders_L@ccnt.usc.edu |
United States, California | |
USC/Norris Comprehensive Cancer Center | Recruiting |
Los Angeles, California, United States, 90033 | |
Contact: Sherida Padilla 323-865-0454 Padilla_S@ccnt.usc.edu | |
Principal Investigator: Parvesh Kumar, MD |
Responsible Party: | University of Southern California ( Parvesh Kumar. MD ) |
Study ID Numbers: | 4P-06-3 |
Study First Received: | April 24, 2008 |
Last Updated: | September 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00669162 |
Health Authority: | United States: Institutional Review Board |
Docetaxel Prostatic Diseases Genital Neoplasms, Male Leuprolide Goserelin |
Bicalutamide Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Neoplasms Neoplasms by Site Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |