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Current SPORE Clinical Trials

Inter-SPORE Prostate Biomarkers Study and Tissue Bank (IRB # 06-09-096-02)
Principal Investigator:	Robert Reiter, M.D (Department of Urology) BOX 951738, 66-128A CHS Los Angeles, CA 90095-1738

Study purpose:

The 11 cancer centers involved in the SPORE program are conducting research to improve our understanding of clinical outcomes in prostate cancer. Patients are asked to give permission to UCLA to collect biological samples, which include blood, and (if the patient is having a biopsy or surgery) prostate tissue. The specimens will be used in this research to determine if certain biological measures (biomarkers) made on the specimen can help indicated the most appropriate treatment. Because this is a collaboration among 11 cancer centers, some of the specimens provided will be sent to researchers at the other collaborating cancer centers. The specimens provided may also be stored (banked) to be used in future prostate cancer research studies. The stored tissue and blood will be maintained by the investigators or research team for this study for 3 years.

This study will take place at UCLA. Men who are eligible for this study must have had a biopsy performed at UCLA and no prior therapy for prostate cancer. Potential risks associated with taking part in this study are mild pain and bruising, lightheadedness or infection as a result of the needle stick. An anticipated benefit of this study is that the information collected may benefit men with prostate cancer in the future.

After initially receiving surgery for prostate cancer, subjects will be asked to return for yearly follow-ups in which specimens will be collected. Those men who decide to take part in this study will be asked to participate for 5 years.

Please contact Nazy Zomorodian at (310) 825-5538 or Lauren Whitted at (310) 825-9262 if you are interested in learning more about this study.

SPORE: Specialized Program Of Research Excellence, A Research Program Funded by the National Cancer Institute SPORE Pre-prostatectomy Nutrition Clinical Trial (IRB# 01-07-026-13A) Principal Investigator: William J. Aronson, M.D.

Study purpose:

Men who are scheduled for radical prostatectomy are considered candidates for this study. Six weeks prior to surgery, the subject will undergo screening procedures to determine eligibility. If eligible, the subject will be randomized to one of two four-week nutrition programs – either a balanced Western Diet or a low-fat diet with fish oil capsules. The UCLA GCRC chefs will prepare breakfast, lunch, and dinner, and meals will be delivered to subjects in coolers two days per week. Subjects will require a minimum of four visits to the UCLA GCRC. Please contact Sherry Jeffery (310) 268-3670 or Dr. William Aronson (waronson@ucla.edu), (310) 268-3446 if you are interested in learning more about this study. The Website (link) for this posting will be: http://www.urology.medsch.ucla.edu/prost_spore-home.htm. Sincerely, William J. Aronson, M.D., F.A.C.S. Clinical Professor of Urology

Neoadjuvant, Multiple Dose, Dose Escalation Phase 1 Trial of the Clinical Safety and Molecular Efficacy of rhIGFBP-3 in Subjects with High Risk Prostate Cancer Who Have Elected to Undergo Radical Prostatectomy (IRB # 07-02-091)

Principal Investigator: Allan Pantuck, M.D. (Department of Urology)
BOX 951738, B7-298A CHS
Los Angeles, CA 90095-1738

Study purpose:

The optimal treatment for patients with locally advanced prostate cancer is particularly controversial. Both radiation therapy and radical prostatectomy have been used to treat advanced prostate cancer either alone or in combination. These approaches have significant limitations in their ability to eliminate locally advanced prostate cancer. Therefore, we desperately need new approaches to treating these patients that hold more promise for long-term local control. We propose to study the use of recombinant human insulin-like growth factor binding protein-3 (rhIGFBP-3) prior to radical prostatectomy, to improve the results of surgery for high-risk patients. This therapy is not yet approved by the US Food and Drug Administration (FDA).

The purpose of this study is to evaluate the safety and effectiveness of rhIGFBP-3 prior to radical prostatectomy. Pre-study tumor biopsies used to establish diagnosis and post-study medication surgical specimens will be analyzed for different biomarkers. Biomarkers are substances in the body fluids or tissues whose levels can indicate if the study medication is having an effect in your body. This is a phase I study. The purpose of a phase I study is to find the best way to give an experimental product and how much of it can be given safely In this study, subjects will be assigned to groups that correspond with increasing doses of the study drug. Physicians watch subjects carefully for any harmful side effects.

Please contact Nazy Zomorodian at (310) 794-7704 or the Office of Clinical Trials at (310) 794-8783 if you are interested in learning more about this study.