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Prostate AdenocarcinomaPhase 1NCT06257693

Enzalutamide Implants (Enolen) in Patients With Prostate Cancer

A Phase 1 study testing enzalutamide in people with Prostate Adenocarcinoma, run by Alessa Therapeutics Inc. at 10 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 21 years and older, men only
Conditions the study is for
Prostate Adenocarcinoma
What is being tested?
enzalutamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
10 sitesUnited States
Study dates
21 Jun 2024to 30 Dec 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

10 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Bonnie Wettersten, MS contact

847-644-9818

bonnie.wettersten@alessatherapeutics.com

Pamela Munster, MD contact

415-216-6099

pamela.munster@alessatherapeutics.com

10 sites in 1 country

United States10 sites, 10 recruiting

  • Johns Hopkins University School of Medicine

    Baltimore, Maryland, 21287

    Rana Harb, 410-502-2276, rharb1@jhmi.edu

    George Metri, 410-502-2276, gmetri1@jh.edu

    Recruiting

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892

    Katie Evans, RN, 240-401-2157, katie.evans@nih.gov

    Peter Pinto, MD

    Recruiting

  • Northwestern University

    Chicago, Illinois, 60611

    Sophia Kallas, 312-694-0633, sophia.kallas@northwestern.edu

    Ashley Ross, MD

    Recruiting

  • Urology Associates of Central California

    Fresno, California, 93720

    Kristin Santeufemia, 559-321-2924, ksanteufemia@urologyassociates.net

    Willian Schiff, MD

    Recruiting

  • Mary Bird Cancer Center

    Metairie, Louisiana, 70002

    Mandy Shipp, mshipp@marybird.com

    Scott Delacroix, MD

    Recruiting

  • Aurora Urology

    Milwaukee, Wisconsin, 53215

    Greg Anderson, 262-442-9368, gregory.anderson@aah.org

    Zachary Kozel, MD

    Recruiting

  • Atlantic Urology Specialists

    Myrtle Beach, South Carolina, 29572

    Taylor Stephenson, 843-449-1010, taylor.stephenson@startresearch.com

    Abhishek Srivastava, MD

    Recruiting

  • VA Portland Health Care System

    Portland, Oregon, 97239

    Laura Onstad, 503-721-1060, laura.onstad@va.gov

    Ryan Kopp, MD

    Recruiting

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

    Genelle Gaudinez, 804-628-6430, gaudinezg@vcu.edu

    Alexander Kenigsberg, MD

    Recruiting

  • University of California San Francisco Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94158

    Imelda Tenggara, 415-353-7348, imelda.tenggara@ucsf.edu

    Hao Nguyen, MD

    Recruiting

Other trials in United States

About this study

Official title: 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.

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.

Being tested
enzalutamide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • enzalutamideDrug

    Also called Radical prostatectomy

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

Study groups in NCT06257693
Study groupRoleWhat they receive
Enolen (tm)ExperimentalEnolen (tm) implants containing enzalutamide
Receives: Drug: enzalutamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: up to 12 months

  2. Measurement of Pharmacokinetics Profile

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

    Measured: up to 12 months

Secondary outcomes (3)

  1. MRI changes

    Prostate and tumor volume changes (mm3)

    Measured: 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

    Measured: 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

    Measured: 6 to 12 weeks post Enolen implantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2024
  2. Study start21 Jun 2024
  3. Primary completion30 Dec 2028 (estimated)
  4. Study completion30 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
open label
Masking
None (open label)
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06257693
Sponsor's protocol ID
EP-001
Other IDs
ZIABC011081
Status last verified
Aug 2026
First submitted
14 Dec 2023
Last updated
11 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Alessa Therapeutics will allow NCI to share data, including genomic data, on this project.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing enzalutamide in people with Prostate Adenocarcinoma, run by Alessa Therapeutics Inc. at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Bonnie Wettersten, MS (847-644-9818, bonnie.wettersten@alessatherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess the adverse events associated with the Enolen implant (time frame: up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06257693.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.

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