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A Phase 2 Randomized Trial of Neoadjuvant Enoblituzumab versus Standard of Care in Men with High-Risk Localized Prostate Cancer: The Help Elucidate & Attack Longitudinally (HEAT) Prostate Cancer Randomized Study
Recruiting
This study aims to improve prostate cancer treatment by testing a drug, enoblituzumab, which targets a protein called B7-H3. Previous research suggests it might boost the immune system to fight cancer. The objective is to see if it delays cancer return compared to standard treatment and identify who responds best.
Male
18 years and over
Inclusion Criteria:
• confirmed adenocarcinoma of the prostate
• an initial prostate biopsy within 3 months of enrollment is available for review, showing at least 3 positive cores, including one with ≥50% involvement and Gleason ≥8
• radical prostatectomy has been scheduled
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
Exclusion Criteria:
• known lymph node involvement on CT or distant metastases on CT or bone scan; non-adenocarcinoma prostate cancers
• previous or concurrent use of radiation, hormonal, biologic, chemotherapy, immunotherapy, experimental agents, 5α-reductase inhibitors, or systemic corticosteroids
• autoimmune diseases requiring systemic immunosuppression; malignancy within the last 3 years; uncontrolled major infections or illnesses
Cancer
Clinics and Surgery Center (CSC), Prostate Cancer
Christopher Warlick - cwarlick@umn.edu
Christopher Warlick, MD
PHASE2
STUDY00022418
See this study on ClinicalTrials.gov