Enzalutamide Implants (Enolen) in Patients With Prostate Cancer

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06257693
Study type	Interventional
Source	Alessa Therapeutics Inc.
Contact	Bonnie Wettersten, MS
Phone	8476449818
Email	bonnie.wettersten@alessatherapeutics.com
Status	Not yet recruiting
Phase	Phase 1
Start date	February 2024
Completion date	August 2025

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See also
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