THE INFORMATION contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies focused on patients with prostate cancer. These studies highlight noninvasive imaging, gene therapy, allogeneic bone marrow transplant, selective androgen receptor modulators, Vitamin D3 supplementation, hypofractionated proton therapy, hormone therapy, and stereotactic body radiotherapy. All of the studies are listed on the National Institutes of Health website at ClinicalTrials.gov.
PHASE I
Study Title: Prostate Specific Membrane Antigen (PSMA)- Based 18F-DCFPyL Positron-Emission Tomography/Computed Tomography (PET/CT) and PET/Magnetic Resonance Imaging (MRI) Pilot Studies in Prostate Cancer
Study Type: Phase I/interventional/single-group assignment
Study Sponsor and Collaborators: University of Wisconsin– Madison, National Cancer Institute
Purpose: To validate and develop a noninvasive imaging biomarker of prostate cancer detection, progression, and recurrence
Principal Investigator: Steve Y. Cho, MD, University of Wisconsin–Madison; contact Cancer Connect, (800) 622-8922, cancerconnect@uwcarbone.wisc.edu
ClinicalTrials.gov Identifier: NCT03232164
***
Study Title: Phase I Trial of in Situ Gene Therapy for Locally Recurrent Prostate Cancer Following Radiation Therapy Failure Using Sodium/Iodide Symporter and Radioiodine
Study Type: Phase I/interventional/single-group assignment
Study Sponsor and Collaborators: Mayo Clinic, National Cancer Institute (NCI)
Purpose: To study 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
Principal Investigator: Brian J. Davis, MD, Mayo Clinic, contact Clinical Trials Referral Office, (855) 776-0015
ClinicalTrials.gov Identifier: NCT00788307
***
Study Title: A Pilot Study of Sex-Mismatched Allogeneic Bone Marrow Transplantation for Men With Metastatic Castration-Resistant Prostate Cancer
Study Type: Phase I/interventional/single-group assignment
Study Sponsor and Collaborators: Sidney Kimmel Comprehensive Cancer Center
Purpose: Men with progressive metastatic castration-resistant prostate cancer post–first-line treatment with either androgen-deprivation therapy alone or androgen-deprivation therapy plus docetaxel who have an identified related female donor (mother, sister, daughter, second-degree relative such as granddaughter or niece) will undergo bone marrow transplantation followed by post-transplant cytoxan and testosterone.
Principal Investigator: Samuel Denmeade, MD, Johns Hopkins University; contact Connie Collins, RN, (410) 955-1017, ccolli23@jhmi.edu
ClinicalTrials.gov Identifier: NCT02995330
PHASE II
Study Title: A Selective Androgen Receptor Modulator for Symptom Management in Prostate Cancer
Study Type: Phase II/interventional/parallel assignment
Study Sponsor and Collaborators: Dana-Farber Cancer Institute, National Institute of Nursing Research
Purpose: To study the use of a targeted therapy called LY SARM, which is an investigational drug from a new class of molecules called selective androgen receptor modulators, as a possible improvement in quality of life for participants who have undergone radical prostatectomy
Principal Investigator: Shalender Bhasin, MD, Brigham and Women’s Hospital; (617) 525-9040, sbhasin@partners.org
ClinicalTrials.gov Identifier: NCT02499497
***
Study Title: Vitamin D3 Supplementation for Low-Risk Prostate Cancer: A Randomized Trial
Study Type: Phase II/interventional/parallel assignment
Study Sponsor and Collaborators: VA Office of Research and Development, Medical University of South Carolina
Purpose: To determine whether vitamin D3 supplementation results in a decrease of positive cancer cores at repeat biopsy in subjects with low-risk prostate cancer
Principal Investigator: Sebastiano Gattoni-Celli, MD, Ralph H. Johnson VA Medical Center; (843) 876-5103, sebastiano.gattoni-celli@va.gov
ClinicalTrials.gov Identifier: NCT01759771 ■
Editor’s Note: The clinical trials presented here do not represent all the trials listed on ClinicalTrials.gov. For the complete list, go to ClinicalTrials.gov.
