RECRUITING

Enzalutamide Implants (Enolen) in Patients With Prostate Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The study is to assess whether the Enolen is safe and delivers anti-androgen medication locally in patients that are planning for radical prostatectomy.

Official Title

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

Quick Facts

Study Start:2024-06-21

Study Completion:2025-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06257693

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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:	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.

Inclusion Criteria

Exclusion 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:

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.

Contacts and Locations

Study Contact

Bonnie Wettersten, MS

CONTACT

8476449818

bonnie.wettersten@alessatherapeutics.com

Pamela Munster, MD

CONTACT

4152166099

pamela.munster@alessatherapeutics.com

Principal Investigator

Peter Pinto, MD

PRINCIPAL_INVESTIGATOR

National Cancer Institute (NCI)

Study Locations (Sites)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892

United States

Collaborators and Investigators

Sponsor: Alessa Therapeutics Inc.

Peter Pinto, MD, PRINCIPAL_INVESTIGATOR, National Cancer Institute (NCI)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-21

Study Completion Date2025-08

Study Record Updates

Study Start Date2024-06-21

Study Completion Date2025-08

Terms related to this study

Additional Relevant MeSH Terms

Prostate Adenocarcinoma