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RecruitingNCT06257693Updated Aug 11, 2026

Enzalutamide Implants (Enolen) in Patients With Prostate Cancer

A Phase 1 interventional study of enzalutamide in Prostate Adenocarcinoma, sponsored by Alessa Therapeutics Inc.. Recruiting at 10 sites in United States. Open to male participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-08-11.

Sponsored by Alessa Therapeutics Inc. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2024; still recruiting 2 years 3 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
45
Allocation
Not applicable
Ages
21 Years and older
Sex
Male
01

Study 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.

Read the detailed description

This study is a multi-center, open-label feasibility study. Approximately 45 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.

Twelve participants in Cohort B receive 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.

02

Conditions studied

  • Prostate Adenocarcinoma
03

In context

Lead sponsor

Alessa Therapeutics Inc. is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
45 participants (estimated)

Study arms

  • Experimental
    Enolen (tm)

    Enolen (tm) implants containing enzalutamide

    Drug: enzalutamide

Interventions

  • Drugenzalutamide

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

    Also known as: Radical prostatectomy

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: up to 12 months

  2. Measurement of Pharmacokinetics Profile

    Enzalutamide plasma (ng/ml), tissue levels (ng/gm) and optional seminal fluid levels (ng/ml)

    Time frame: up to 12 months

Secondary outcomes

  1. MRI changes

    Prostate and tumor volume changes (mm3)

    Time frame: up to 12 months post Enolen implantation

  2. Changes in Prostate-specific antigen (PSA)

    Measurements of the amount of PSA in the blood (ng/ml) at baseline through 6-12 weeks post radical prostatectomy

    Time frame: 6 to 12 weeks post radical prostatectomy

  3. Changes in Testosterone

    Measurements of testosterone levels in the blood (ng/dl) from baseline to radical prostatectomy

    Time frame: 6 to 12 weeks post Enolen implantation

07

Study locations

10 of 10 sites recruiting
  • Urology Associates of Central California
    Fresno, California 93720, United States
    Recruiting
  • University of California San Francisco Helen Diller Family Comprehensive Cancer Center
    San Francisco, California 94158, United States
    Recruiting
  • Northwestern University
    Chicago, Illinois 60611, United States
    Recruiting
  • Mary Bird Cancer Center
    Metairie, Louisiana 70002, United States
    Recruiting
  • Johns Hopkins University School of Medicine
    Baltimore, Maryland 21287, United States
    • Rana Harb · Contact · rharb1@jhmi.edu · 410-502-2276
    • George Metri · Contact · gmetri1@jh.edu · 410-502-2276
    • Arvin George, MD · Principal investigator
    Recruiting
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
    • Katie Evans, RN · Contact · katie.evans@nih.gov · 240-401-2157
    • Peter Pinto, MD · Principal investigator
    Recruiting
  • VA Portland Health Care System
    Portland, Oregon 97239, United States
    • Laura Onstad · Contact · laura.onstad@va.gov · 503-721-1060
    • Ryan Kopp, MD · Principal investigator
    Recruiting
  • Atlantic Urology Specialists
    Myrtle Beach, South Carolina 29572, United States
    Recruiting
  • Virginia Commonwealth University
    Richmond, Virginia 23298, United States
    • Genelle Gaudinez · Contact · gaudinezg@vcu.edu · 804-628-6430
    • Alexander Kenigsberg, MD · Principal investigator
    Recruiting
  • Aurora Urology
    Milwaukee, Wisconsin 53215, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Alessa Therapeutics will allow NCI to share data, including genomic data, on this project.

Supporting information: Study protocol, Icf, Csr

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06257693
Lead sponsor
Alessa Therapeutics Inc.
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Feb 14, 2024
Start date
Jun 21, 2024
Primary completion
Dec 30, 2028 (estimated)
Completion
Dec 30, 2028 (estimated)
Last update
Aug 11, 2026

Study contacts

Bonnie Wettersten, MS
Contact
bonnie.wettersten@alessatherapeutics.com
847-644-9818
Pamela Munster, MD
Contact
pamela.munster@alessatherapeutics.com
415-216-6099
Peter Pinto, MD
principal investigator · National Cancer Institute (NCI)

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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