Clinical trial NCT06257693: Enzalutamide Implants (Enolen) in Patients With Prostate Cancer
Official title: A Phase 1 Study to Establish the Feasibility of Enolen (tm) for the Local Delivery of Enzalutamide in Patients With Prostate Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Prostate Adenocarcinoma
Lead sponsor: Alessa Therapeutics Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-02-14
Enrollment: 20
Sex: MALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: open label
Primary purpose: TREATMENT

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.

Detailed description: This study is a single-center, open-label feasibility study. Up to 20 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. Six to twelve weeks later, the patient will undergo a repeat MRI followed by standard of care radical 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.

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. PSA greater or equal to 3 ng/mL within 3 months of screening
6. Gleason score 3+4 or higher
7. Study participant must be willing to undergo post-treatment imaging by MRI
8. Participants must be able to understand and sign the informed consent form
9. ECOG performance status 0 or 1
10. Adequate organ function, including absolute neutrophil count (ANC) ≥1500 cells/μL, hemoglobin ≥90 g/dL, platelets ≥100,000 cells/μL, estimated creatinine clearance ≥50 mL/min, bilirubin \<1.5x ULN (\< 3x ULN for documented Gilbert's syndrome)
11. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and Alkaline phosphatase \<2.5x ULN
12. 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 tie 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. Use of 5 alpha reductase inhibitors (e.g., Finasteride or Dutasteride) within 3 months of screening.
8. Presence of any metastatic disease.
9. No evidence of extracapsular extension of disease.
10. 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.
11. History of prostate infection within 2 years.
12. No intercurrent medical condition or circumstances that would preclude prostatectomy.
13. History of bleeding diathesis or currently on anti-coagulation therapy that cannot be safely discontinued for implant procedure.
14. 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.

Primary outcomes:
measure: To assess the adverse events associated with the Enolen implant
timeFrame: 3 months
measure: Measurement of Pharmacokinetics Profile
timeFrame: 6 months
Secondary outcomes:
measure: MRI changes
timeFrame: 6 to 12 weeks post Enolen implantation
measure: Changes in Prostate-specific antigen (PSA)
timeFrame: 6 to 12 weeks post radical prostatectomy
measure: Changes in Testosterone
timeFrame: 6 to 12 weeks post Enolen implantation
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: National Cancer Institute (NCI)
name: Peter Pinto, MD
role: PRINCIPAL_INVESTIGATOR
References: