Brian J. Davis, M.D., Ph.D.

Closed for Enrollment

• A Multi-Center Trial of Androgen Suppression With Abiraterone aCetate, LEuprolide, PARP Inhibition and Stereotactic Body Radiotherapy (ASCLEPIuS): A Phase I/2 Trial in High Risk and Node Positive Prostate Cancer (ASCLEPIuS) Rochester, Minn.

  The purpose of this study is to establish the maximum tolerable dose of niraparib when combined with prostate stereotactic body radiotherapy (SBRT), abiraterone, leuprolide, and prednisone (phase 1 portion of the study) and determine 3-year biochemical PSA recurrence free-survival with this treatment approach (phase 2 portion of the study).

• A Randomized, Parallel Phase II Trial of Hypofractionated Proton Therapy or IMRT for Recurrent, Oligometastatic Prostate Cancer involving Only Pelvic and/or Para-aortic Lymph Nodes Following Primary Localized Treatment Rochester, Minn.

  The purpose of this study is to assess late > grade 3 GI and/or GU toxicity of interest with the hypofractionated regimen with proton beam therapy or IMRT (late defined as 3 to 24 months after protocol RT).

• Phase I Trial of In Situ Gene Therapy for Locally Recurrent Prostate Cancer using Sodium/Iodide Symporter and Radioiodine Rochester, Minn.

  RATIONALE: Radioactive drugs, such as radioactive iodine, may carry radiation directly to tumor cells and not harm normal cells. Placing a gene called Ad5CMV-NIS in prostate cancer cells may help the prostate cells take in more radioactive iodine and thus kill the cancer cells. Drugs, such as liothyronine sodium, may protect the thyroid from the side effects of radioactive iodine.

  PURPOSE: This phase I trial is studying the side effects and best dose of gene therapy given together with radioactive iodine in treating patients with locally recurrent prostate cancer that did not respond to external-beam radiation therapy.