A phase 1 safety and feasibility study of intratumoral placement of bicalutamide implants combined with radiotherapy for localized prostate cancer.

person Deborah E. Citrin National Cancer Institute, Bethesda, MD info_outline Deborah E. Citrin, Baris Turkbey, Krishnan Patel, Stephanie A Harmon, Peter A Pinto, Brad Wood, Sandeep Gurram, Holly Ning, Debbie-Ann Nathan, Pujan K Desai, Maithili Rairkar, Peter Choyke, Pamela N. Munster, Cassidy Mileti

Authors person Deborah E. Citrin National Cancer Institute, Bethesda, MD info_outline Deborah E. Citrin, Baris Turkbey, Krishnan Patel, Stephanie A Harmon, Peter A Pinto, Brad Wood, Sandeep Gurram, Holly Ning, Debbie-Ann Nathan, Pujan K Desai, Maithili Rairkar, Peter Choyke, Pamela N. Munster, Cassidy Mileti Organizations National Cancer Institute, Bethesda, MD, Molecular Imaging Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD, Radiation Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD, National Cancer Institute, National Institutes of Health, Bethesda, MD, Urologic Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD, Center for Interventional Oncology, National Cancer Institute, National Institutes of Health, Bethesda, MD, Alessa Therapeutics, San Carlos, CA, National Cancer Institute, Molecular Imaging Branch, Bethesda, MD Abstract Disclosures Research Funding National Cancer Institute Background: Systemic androgen deprivation therapy (ADT) is an integral part of therapy for unfavorable intermediate or high-risk prostate cancer treated with radiation therapy (RT). However, systemic anti-androgens are associated with considerable cardiovascular, metabolic, and sexual side effects leading to omission and contraindication in many men. We tested the feasibility of replacing systemic ADT with targeted local delivery of an anti-androgen agent (bicalutamide, Biolen Implant). The Biolen implant consists of a medical grade silicone polymer mixed with 6.3mg bicalutamide into a solid rod-shaped scaffold approximately 0.95 x 15 mm in size. Pre-clinical studies have demonstrated that a silicone/bicalutamide implant is a feasible method for durable localized delivery of an anti-androgen into the prostate. Results for the preclinical studies were presented at the AACR Symposium in April 2023 (Poster # 5261). Methods: Trial Design: This study (CP-002, NCT04943536) is a prospective, single-center, single-arm feasibility study to assess the safety, feasibility and PK profile for Biolen for the localized delivery of bicalutamide into the prostate when delivered with radiotherapy. Up to 20 participants with intermediate to high risk localized prostate cancer who are planned to receive RT and are candidates for systemic ADT will be enrolled. Study participants will have placement of the drug eluting Biolen (bicalutamide) implants. Participants will receive standard of care radiation 9 weeks after implant and will be followed through 2 years post radiation. Patients will undergo plasma collection after Biolen implant at Day 1, 3, Week 1, 2, 4 and seminal fluid collection at 4-7 and 8 weeks for assessment of bicalutamide levels. An MRI will be performed at 6 and 24 months after completion of radiation. Key Eligibility: Patients must have at least 1 MRI detected, biopsy proven localized prostate cancer lesion in whom prostate radiation and ADT is appropriate therapy (such as Intermediate Risk localized prostate cancer). Patients diagnosed as one of the following: a) NCCN intermediate risk prostate cancer, b) NCCN high risk prostate cancer due to Gleason Grade 4 or 5 AND refuses to receive systemic ADT, c) NCCN high risk prostate cancer due to PSA > 20 AND refuses to receive systemic ADT. Trial Status: The study is ongoing at the NCI and 9 patients have been enrolled to date. Clinical trial information: NCT04943536.

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