Enzalutamide Implants (Enolen) in Patients With Prostate Cancer

February 24, 2026 updated by: Alessa Therapeutics Inc.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

56

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
    • Louisiana
      • Metairie, Louisiana, United States, 70002
        • Recruiting
        • Mary Bird Cancer Center
        • Principal Investigator:
          • Scott Delacroix, MD
        • Contact:
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • Recruiting
        • National Institutes of Health Clinical Center
        • Principal Investigator:
          • Peter Pinto, MD
        • Contact:
    • Oregon
      • Portland, Oregon, United States, 97239
        • Not yet recruiting
        • VA Portland Health Care System
        • Contact:
        • Principal Investigator:
          • Ryan Kopp, MD
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Recruiting
        • Atlantic Urology Specialists
        • Principal Investigator:
          • Abhishek Srivastava, MD
        • Contact:
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • Virginia Commonwealth University
        • Principal Investigator:
          • Alexander Kenigsberg, MD
        • Contact:
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Recruiting
        • Aurora Urology
        • Contact:
        • Principal Investigator:
          • Zachary Kozel, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age at least 21 years old
  2. Histologically confirmed adenocarcinoma of the prostate
  3. Study participant qualified and planning for radical prostatectomy
  4. At least 1 prostate lesion measurable by MRI greater or equal to 0.5 cm
  5. Cohort A and Cohort B: Gleason score 3+4 or higher Cohort C: Gleason score 3+3 with high risk features or 3+4
  6. Study participant must be willing to undergo post-treatment imaging by MRI
  7. Participants must be able to understand and sign the informed consent form
  8. ECOG performance status 0 or 1
  9. Adequate organ function, including absolute neutrophil count (ANC) ≥1000 cells/μL, hemoglobin ≥9 g/dL, platelets ≥100,000 cells/μL, estimated creatinine clearance ≥50 mL/min, bilirubin <1.5x ULN (< 3x ULN for documented Gilbert's syndrome)
  10. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and Alkaline phosphatase <2.5x ULN
  11. The effects of Enolen on the developing human fetus are unknown. For this reason and because other therapeutic agents used in this trial are known to be teratogenic, men must agree to use a highly effective form of contraception or abstinence at the time of study entry and continuing through three months after radical prostatectomy/implant removal. Highly effective forms of contraception include:

Vasectomy Condom with spermicide

Partner use of one of the following methods:

Postmenopausal >1 year or age >55y Bilateral tubal ligation Intrauterine devices (IUDs) Hormonal implants (Implanon, Nexplanon, etc.) Combination oral contraceptives Progestin-only injections (Depo-Provera) Hormonal patches Vaginal Ring Should a woman become pregnant or suspect she is pregnant while her partner is participating in this study, the treating physician should be informed immediately.

Exclusion Criteria:

  1. Prior radiotherapy or surgery for prostate cancer
  2. Ongoing hormonal therapy for prostate cancer or hormone therapy <3 months prior to the start of treatment
  3. Prior prostate procedures such as transurethral resection of the prostate, transurethral microwave thermotherapy of the prostate, high-intensity focused ultrasound or minimally invasive Benign Prostate Hyperplasia (BPH) procedure
  4. Study participant unwilling or unable to undergo MRI, including participants with contra-indications to MRI, such as cardiac pacemakers, non-compatible intracranial vascular clips, etc.
  5. Metallic hip implant or any other metallic implant or device that distorts the quality of prostatic MR images.
  6. Study participants who, because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent.
  7. Presence of any metastatic disease.
  8. No evidence of extracapsular extension of disease.
  9. Study participants, who in the opinion of the treating clinician, would be at increased risk of refractory urinary retention due to a transperineal procedure such as the Enolen implant.
  10. History of prostate infection within 2 years.
  11. No intercurrent medical condition or circumstances that would preclude prostatectomy.
  12. History of bleeding diathesis or currently on anti-coagulation therapy that cannot be safely discontinued for implant procedure.
  13. Any condition that, in the opinion of the Principal Investigator, which would impair the participant's ability to comply with study procedures and undergo prostatectomy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Enolen (tm)
Enolen (tm) implants containing enzalutamide
Drug: enzalutamide
Localized single delivery of the Enolen implant (polymer + enzalutamide) with planned radical prostatectomy
Other Names:
  • Radical prostatectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the adverse events associated with the Enolen implant
Time Frame: up to 12 months
Using Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v.5.0).
up to 12 months
Measurement of Pharmacokinetics Profile
Time Frame: up to 12 months
Enzalutamide plasma (ng/ml) and tissue levels (ng/gm)
up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Prostate-specific antigen (PSA)
Time Frame: 6 to 12 weeks post radical prostatectomy
Measurements of the amount of PSA in the blood (ng/ml) at baseline through 6-12 weeks post radical prostatectomy
6 to 12 weeks post radical prostatectomy
Changes in Testosterone
Time Frame: 6 to 12 weeks post Enolen implantation
Measurements of testosterone levels in the blood (ng/dl) from baseline to radical prostatectomy
6 to 12 weeks post Enolen implantation
MRI changes
Time Frame: up to 12 months post Enolen implantation
Prostate and tumor volume changes (mm3)
up to 12 months post Enolen implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alessa Therapeutics Inc.

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Peter Pinto, MD, National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 21, 2024

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

August 30, 2028

Study Registration Dates

First Submitted

December 14, 2023

First Submitted That Met QC Criteria

February 5, 2024

First Posted (Actual)

February 14, 2024

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 24, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EP-001
  • ZIABC011081 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Alessa Therapeutics will allow NCI to share data, including genomic data, on this project.

IPD Sharing Time Frame

Data is shared after the completion of the study.

IPD Sharing Access Criteria

Data will be provided by the sponsor/Alessa Therapeutics to the NIH for sharing per the NIH Data Managment and Sharing Policy

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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