The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies focused on prostate cancer. These trials are studying bone marrow transplant, gene therapy, checkpoint inhibitor treatment, radiation therapy techniques, antibody therapies, and improvement of surgical strategies. All of the studies are listed on the National Institutes of Health website at ClinicalTrials.gov.
PHASE I
Study Title: A Pilot Study of Sex-Mismatched Allogeneic Bone Marrow Transplantation for Men With Metastatic Castration-Resistant Prostate Cancer
Study Type: Interventional/single-group assignment
Study Sponsor and Collaborators: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Purpose: To test the effectiveness of first-line treatment with either androgen-deprivation therapy alone or androgen-deprivation therapy plus docetaxel followed by bone marrow transplantation (from an identified related female donor [mother, sister, daughter, or second-degree relative such as granddaughter or niece]) and then treated with posttransplant cyclophosphamide and testosterone in metastatic castration-resistant prostate cancer
Primary Outcome Measures: Prostate-specific antigen response [time frame: 5 years]
Principal Investigator: Samuel Denmeade, MD; contact Connie Collin, RN, (410) 955-1017, ccolli23@jhmi.edu
ClinicalTrials.gov Identifier: NCT02995330
Study Title: Phase I Trial of Oncolytic Adenovirus-Mediated Cytotoxic and Interleukin-12 Gene Therapy for Locally Recurrent Prostate Cancer After Definitive Radiotherapy
Study Type: Interventional/single-group assignment
Study Sponsor and Collaborators: Henry Ford Health System
Purpose: To determine the dose-dependent toxicity and maximum tolerated dose of oncolytic adenovirus-mediated cytotoxic and interleukin-12 gene therapy in men with locally recurrent prostate cancer after definitive radiotherapy
Primary Outcome Measures: Dose-dependent toxicity and maximum tolerated dose of adenovirus [time frame: 30 days from date of adenovirus injection (defined as day 1)]
Principal Investigator: Hans Stricker, MD, (313) 916-7658, hstrick1@hfhs.org; Farzan Siddiqui, MD, PhD, (313) 916-1021, fsiddiq2@hfhs.org
ClinicalTrials.gov Identifier: NCT02555397
PHASE II
Study Title: PD-L1 Inhibition as Checkpoint Immunotherapy for Neuroendocrine Phenotype Prostate Cancer
Study Type: Interventional/single-group assignment
Study Sponsor and Collaborators: Duke University
Purpose: To assess the safety and efficacy of the programmed cell death ligand 1 (PD-L1) inhibitor avelumab in patients with metastatic neuroendocrine-like prostate cancer
Primary Outcome Measures: Efficacy of PD-L1 inhibition with avelumab as determined by immunotherapy Response Evaluation Criteria in Solid Tumors [time frame: baseline to end of treatment (approximately 6 months)]
Principal Investigator: Andrew Armstrong, MD, ScM; contact Julia Rasmussen, MS, RN, BSN, (919) 681-1030, julia.rasmussen@duke.edu
ClinicalTrials.gov Identifier: NCT03179410
Study Title: A Salvage Trial of AR Inhibition With ADT and Apalutamide With Radiation Therapy Followed by Docetaxel in Men With PSA-Recurrent Prostate Cancer After Radical Prostatectomy (STARTAR)
Study Type: Interventional/single-group assignment
Study Sponsor and Collaborators: Duke University
Purpose: To determine the rate of 3-year progression-free survival in men with recurrent prostate specific antigen (PSA)-only disease after prostatectomy who receive combined apalutamide and standard androgen-deprivation therapy with salvage radiation therapy followed by docetaxel, androgen-deprivation therapy, and apalutamide and also to determine which patients have had testosterone recovery to > 100 ng/dL at 36 months
Primary Outcome Measures: Progression-free survival at 36 months [time frame: 36 months]
Principal Investigator: Tian Zhang, MD; contact Julia Rasmussen, MS, RN, BSN, (919) 681-1030, julia.rasmussen@duke.edu
ClinicalTrials.gov Identifier: NCT03311555
PHASE III
Study Title: A Phase III Prospective Randomized Trial of Standard Fractionation vs Hypofractionation With Proton Radiation Therapy for Low-Risk Adenocarcinoma of the Prostate
Study Type: Interventional/randomized/parallel assignment
Study Sponsor and Collaborators: Proton Collaborative Group
Purpose: To compare the effects on patients with prostate cancer by comparing the standard dose of radiation therapy (44 treatments over 8.5–9 weeks) with a higher daily dose of radiation (5 treatments over 1–2 weeks)
Primary Outcome Measures: To assess whether hypofractionation will result in 2-year freedom from failure that is noninferior to that with standard fractionation. Freedom from failure will be measured by recurrence, metastasis, PSA level, or start of salvage therapy [time frame: at 5 years’ posttreatment completion ± 90 days]
Principal Investigator: Carlos Vargas, MD; visit clinicaltrials.gov for a full list of trial sites and contact information
ClinicalTrials.gov Identifier: NCT01230866
Study Title: A Randomized Trial of Modifications to Radical Prostatectomy
Study Type: Interventional/randomized/factorial assignment
Study Sponsor and Collaborators: Memorial Sloan Kettering Cancer Center
Purpose: To determine how different ways of performing prostate cancer surgery affect patient outcomes, such as recurrence of cancer or regaining control of bladder function after surgery
Primary Outcome Measures: Patient-reported hernia [time frame: 1 year]
Principal Investigator: Andrew Vickers, PhD, (646) 735-8142
ClinicalTrials.gov Identifier: NCT01407263 ■
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.
