Enzalutamide Implants (Enolen) in Patients With Prostate Cancer

NCT06257693 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: EP-001ZIABC011081
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 7

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.

Conditions

Prostate Adenocarcinoma

Outcome Measures

Primary Outcomes (2)

• To assess the adverse events associated with the Enolen implant

  Using Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v.5.0).

  up to 12 months

• Measurement of Pharmacokinetics Profile

  Enzalutamide plasma (ng/ml) and tissue levels (ng/gm)

  up to 12 months

Secondary Outcomes (3)

• MRI changes

  up to 12 months post Enolen implantation

• Changes in Prostate-specific antigen (PSA)

  6 to 12 weeks post radical prostatectomy

• Changes in Testosterone

  6 to 12 weeks post Enolen implantation

Study Arms (1)

Enolen (tm)

EXPERIMENTAL

Enolen (tm) implants containing enzalutamide

Drug: enzalutamide

Interventions

enzalutamide DRUG

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

Also known as: Radical prostatectomy

Enolen (tm)

Eligibility Criteria

• Age: 21 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age at least 21 years old
• Histologically confirmed adenocarcinoma of the prostate
• Study participant qualified and planning for radical prostatectomy
• At least 1 prostate lesion measurable by MRI greater or equal to 0.5 cm
• Cohort A and Cohort B: Gleason score 3+4 or higher Cohort C: Gleason score 3+3 with high risk features or 3+4
• Study participant must be willing to undergo post-treatment imaging by MRI
• Participants must be able to understand and sign the informed consent form
• ECOG performance status 0 or 1
• 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)
• Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and Alkaline phosphatase \<2.5x ULN
• 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.

You may not qualify if:

• Prior radiotherapy or surgery for prostate cancer
• Ongoing hormonal therapy for prostate cancer or hormone therapy \<3 months prior to the start of treatment
• 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
• 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.
• Metallic hip implant or any other metallic implant or device that distorts the quality of prostatic MR images.
• Study participants who, because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent.
• Presence of any metastatic disease.
• No evidence of extracapsular extension of disease.
• 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.
• History of prostate infection within 2 years.
• No intercurrent medical condition or circumstances that would preclude prostatectomy.
• History of bleeding diathesis or currently on anti-coagulation therapy that cannot be safely discontinued for implant procedure.
• 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.

Sponsors & Collaborators

• Alessa Therapeutics Inc.: lead
• National Cancer Institute (NCI): collaborator

Study Sites (7)

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

Mary Bird Cancer Center

Metairie, Louisiana, 70002, United States

RECRUITING

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

VA Portland Health Care System

Portland, Oregon, 97239, United States

NOT YET RECRUITING

Atlantic Urology Specialists

Myrtle Beach, South Carolina, 29572, United States

RECRUITING

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

RECRUITING

Aurora Urology

Milwaukee, Wisconsin, 53215, United States

RECRUITING

MeSH Terms

Interventions

enzalutamide

Study Officials

• Peter Pinto, MD

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bonnie Wettersten, MS

CONTACT

847-644-9818; bonnie.wettersten@alessatherapeutics.com

Pamela Munster, MD

CONTACT

415-216-6099; pamela.munster@alessatherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: open label

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: February 14, 2024
• Study Start: June 21, 2024
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): August 30, 2028
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Data is shared after the completion of the study.
• Access Criteria: Data will be provided by the sponsor/Alessa Therapeutics to the NIH for sharing per the NIH Data Managment and Sharing Policy

Locations

US (7)