NCT06257693

Enzalutamide Implants (Enolen) in Patients With Prostate Cancer

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Alessa Therapeutics Inc. · Industry
• Sex: Male
• Age: 21 Years
• Healthy volunteers: Not accepted

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 multi-center, open-label feasibility study. Up to 56 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 followed by a standard of care prostatectomy 6-12 weeks or 4-12 months post-implant procedure. Twenty participants in Cohort A receive up to 16 implants and have a prostatectomy planned between weeks 6 and 12 post-implant procedure. Twenty-four participants in Cohort B are randomized to 8 or 16 implants and have a prostatectomy planned between weeks 6 and 12 post-implant procedure. Twelve participants in Cohort C receive 16 implants and have a prostatectomy planned between months 4 and 12 post-implant procedure. If the participant is unwilling to undergo the prostatectomy by 12 months, they must agree to close monitoring with imaging by MRI every three months and biopsies, as indicated, for up to 24 months post-implant procedure. Study participants are followed for 2-6 weeks post-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.

Conditions

• Prostate Adenocarcinoma

Interventions

Type	Name	Description
DRUG	enzalutamide	Localized single delivery of the Enolen implant (polymer + enzalutamide) with planned radical prostatectomy

Timeline

• Start date: 2024-06-21
• Primary completion: 2028-06-30
• Completion: 2028-08-30
• First posted: 2024-02-14
• Last updated: 2026-02-27

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study