Enzalutamide Implants (Enolen) in Patients With Prostate Cancer

Prostate Adenocarcinoma Clinical Trial

Official title:

A Phase 1 Study to Establish the Feasibility of Enolen (tm) for the Local Delivery of Enzalutamide in Patients With Prostate Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06257693
• Other study ID #: EP-001
• Secondary ID: ZIABC011081
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: February 2024
• Est. completion date: August 2025

Study information

• Verified date: February 2024
• Source: Alessa Therapeutics Inc.
• Contact: Bonnie Wettersten, MS
• Phone: 8476449818
• Email: bonnie.wettersten[@]alessatherapeutics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: August 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Prostate Adenocarcinoma

Intervention

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

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Alessa Therapeutics Inc.	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	3 months
Primary	Measurement of Pharmacokinetics Profile	Enzalutamide plasma (ng/ml) and tissue levels (ng/gm)	6 months
Secondary	MRI changes	Prostate and tumor volume changes (mm3)	6 to 12 weeks post Enolen implantation
Secondary	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	6 to 12 weeks post radical prostatectomy
Secondary	Changes in Testosterone	Measurements of testosterone levels in the blood (ng/dl) from baseline to radical prostatectomy	6 to 12 weeks post Enolen implantation