Spots Global Cancer Trial Database for Enzalutamide Implants (Enolen) in Patients With Prostate Cancer

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Trial Identification

Brief Title: Enzalutamide Implants (Enolen) in Patients With Prostate Cancer

Official Title: A Phase 1 Study to Establish the Feasibility of Enolen (tm) for the Local Delivery of Enzalutamide in Patients With Prostate Cancer

Study ID: NCT06257693

Conditions

Prostate Adenocarcinoma

Interventions

enzalutamide

Study Description

Brief Summary: The study is to assess whether the Enolen is safe and delivers anti-androgen medication locally in patients that are planning for radical prostatectomy.

Detailed Description: This study is a single-center, open-label feasibility study. Up to 20 participants planning for radical prostatectomy will be recruited to assess the safety and patient tolerance of Enolen for the localized delivery of enzalutamide into the prostate. At baseline, patients will undergo multiparametric MRI of the prostate. Study participants will have placement of the drug eluting Enolen implants. Six to twelve weeks later, the patient will undergo a repeat MRI followed by standard of care radical prostatectomy. Participants will be followed for an additional 6-12 weeks post surgery. Clinical labs and correlative sample collection and patient quality of life questionnaires will be administered at follow-up visits.