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| Sponsor: | Duke University |
|---|---|
| Collaborators: |
Pfizer Sanofi-Aventis |
| Information provided by: | Duke University |
| ClinicalTrials.gov Identifier: | NCT00734851 |
Purpose
This is a single arm phase II study of docetaxel, prednisone, and sunitinib systemic therapy followed by salvage external beam radiation therapy for men who have experienced PSA recurrence following initial radical prostatectomy for prostate cancer. The primary aim is the rate of progression-free survival at 2 years as measured by lack of PSA progression and no evidence of disease. We hypothesize that this aggressive initial systemic therapy will improve the long term remission rates for men who are undergoing salvage radiation therapy for PSA recurrence in the absence of metastatic disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: Docetaxel Drug: Sunitinib Radiation: EBXRT |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study |
| Official Title: | Multimodality Therapy for Recurrent High Risk Prostate Cancer: A Phase II Study |
| Estimated Enrollment: | 38 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
In many common malignancies such as breast cancer, trimodality therapy represents the standard-of-care approach, including initial surgical resection followed by systemic chemotherapy followed by radiotherapy for optimal local control, and targeted hormonal or biologic therapy for a period of time to reduce the ongoing risk of systemic disease recurrence. These approaches have reduced recurrence rates and improved overall survival in the adjuvant setting in breast cancer; however, the treatment of men with PSA recurrence following radical prostatectomy has generally been unsatisfying, given the high rates of persistent or recurrent disease despite salvage radiotherapy.
The primary purpose of the study is to determine the rate of biochemical (PSA) progression free survival (bPFS) in men with PSA recurrent non-metastatic prostate cancer following radical prostatectomy, who receive multimodality therapy consisting of local salvage external beam radiotherapy and systemic docetaxel-based chemotherapy plus the targeted anti-VEGF biologic therapy sunitinib. Biochemical PFS will be defined as the proportion of subjects at 24 months, post-registration, with one of the following: 1) a serum PSA value of 0.2 ng/ml or more above the post-radiotherapy PSA nadir and confirmed 4 weeks later by a second PSA measurement that was higher than the first by any amount, 2) a continued rise in the PSA level following study treatment if no nadir is experienced, defined as 2 rising values greater than the baseline PSA and separated by at least 4 weeks, 3) evidence of clinical progression or initiation of systemic therapy for progressive disease, or 4) death. Secondary objectives include finding the rate of biochemical (PSA) disease free survival over time, Two-, three-, five-, and six- year risk of local recurrence (proportion), two-, three-, five-, and six-year risk of metastases and metastasis-free survival, two-, three-, five-, and six-year risk of metastases and metastasis-free survival, Safety, feasibility, and tolerability as assessed by NCI Common Toxicity Scales (v3.0), quality of life questionnaire (EPIC-short form surveys), achievement of accrual goals. Finally, a comparison of RNA expression profiles from original prostate radical prostatectomy specimen among those with PSA relapse at 2 and 5 years as compared to those without PSA relapse at the primary endpoint.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate laboratory parameters:
Exclusion Criteria:
Contacts and Locations| Contact: Andrew J Armstrong, MD, ScM | 919-668-8108 ext 2 | andrew.armstrong@duke.edu |
| Contact: Patricia Creel, RN | 919-6680635 | patricia.creel@duke.edu |
| United States, Maryland | |
| Johns Hopkins University | Not yet recruiting |
| Baltimore, Maryland, United States, 21218 | |
| United States, North Carolina | |
| Duke University | Recruiting |
| Durham, North Carolina, United States, 27705 | |
| Contact: Patricia Creel, RN 919-668-0635 patricia.creel@duke.edu | |
| Contact: Terry Witting 919-668-8108 terry.witting@duke.edu | |
| Principal Investigator: Andrew J Armstrong, MD, ScM | |
| Principal Investigator: | Andrew J Armstrong, MD, ScM | Duke University |
More Information
| Responsible Party: | Duke University ( Andrew J. Armstrong, MD ScM ) |
| Study ID Numbers: | 10747 |
| Study First Received: | August 13, 2008 |
| Last Updated: | March 15, 2009 |
| ClinicalTrials.gov Identifier: | NCT00734851 History of Changes |
| Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
|
prostate cancer sunitinib docetaxel PSA |
radiation PSA recurrence No metastatic disease |
|
Sunitinib Docetaxel Genital Neoplasms, Male Prostatic Diseases Antineoplastic Agents Growth Substances Physiological Effects of Drugs Urogenital Neoplasms Genital Diseases, Male |
Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Prostatic Neoplasms |