NCT06257693 Enzalutamide Implants (Enolen) in Patients With Prostate Cancer
| NCT ID | NCT06257693 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Alessa Therapeutics Inc. |
| Condition | Prostate Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 56 participants |
| Start Date | 2024-06-21 |
| Primary Completion | 2028-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 56 participants in total. It began in 2024-06-21 with a primary completion date of 2028-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Peter Pinto, MD
PRINCIPAL INVESTIGATOR
National Cancer Institute (NCI)
Frequently Asked Questions
Who can join the NCT06257693 clinical trial?
This trial is open to male participants only, aged 21 Years or older, studying Prostate Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06257693 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06257693 currently recruiting?
Yes, NCT06257693 is actively recruiting participants. Contact the research team at bonnie.wettersten@alessatherapeutics.com for enrollment information.
Where is the NCT06257693 trial being conducted?
This trial is being conducted at Chicago, United States, Metairie, United States, Bethesda, United States, Portland, United States and 3 additional locations.
Who is sponsoring the NCT06257693 clinical trial?
NCT06257693 is sponsored by Alessa Therapeutics Inc.. The principal investigator is Peter Pinto, MD at National Cancer Institute (NCI). The trial plans to enroll 56 participants.