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
The study is to assess whether the Enolen is safe and delivers anti-androgen medication locally in patients that are planning for radical prostatectomy.
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.
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.
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:
Enolen (tm) implants containing enzalutamide
Drug: enzalutamide
Localized single delivery of the Enolen implant (polymer + enzalutamide) with planned radical prostatectomy
Also known as: Radical prostatectomy
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
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
MRI changes
Prostate and tumor volume changes (mm3)
Time frame: up to 12 months post Enolen implantation
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
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
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.
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Alessa Therapeutics Inc.