Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2025-12-25 @ 11:16 PM
Study NCT ID:
NCT06257693
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2023-12-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Enzalutamide Implants (Enolen) in Patients With Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C540278', 'term': 'enzalutamide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'open label'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-26', 'studyFirstSubmitDate': '2023-12-14', 'studyFirstSubmitQcDate': '2024-02-05', 'lastUpdatePostDateStruct': {'date': '2024-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the adverse events associated with the Enolen implant', 'timeFrame': '3 months', 'description': 'Using Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v.5.0).'}, {'measure': 'Measurement of Pharmacokinetics Profile', 'timeFrame': '6 months', 'description': 'Enzalutamide plasma (ng/ml) and tissue levels (ng/gm)'}], 'secondaryOutcomes': [{'measure': 'MRI changes', 'timeFrame': '6 to 12 weeks post Enolen implantation', 'description': 'Prostate and tumor volume changes (mm3)'}, {'measure': 'Changes in Prostate-specific antigen (PSA)', 'timeFrame': '6 to 12 weeks post radical prostatectomy', 'description': 'Measurements of the amount of PSA in the blood (ng/ml) at baseline through 6-12 weeks post radical prostatectomy'}, {'measure': 'Changes in Testosterone', 'timeFrame': '6 to 12 weeks post Enolen implantation', 'description': 'Measurements of testosterone levels in the blood (ng/dl) from baseline to radical prostatectomy'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Adenocarcinoma']}, 'descriptionModule': {'briefSummary': 'The study is to assess whether the Enolen is safe and delivers anti-androgen medication locally in patients that are planning for radical prostatectomy.', 'detailedDescription': '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.\n\nAt 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.\n\nParticipants 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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age at least 21 years old\n2. Histologically confirmed adenocarcinoma of the prostate\n3. Study participant qualified and planning for radical prostatectomy\n4. At least 1 prostate lesion measurable by MRI greater or equal to 0.5 cm\n5. PSA greater or equal to 3 ng/mL within 3 months of screening\n6. Gleason score 3+4 or higher\n7. Study participant must be willing to undergo post-treatment imaging by MRI\n8. Participants must be able to understand and sign the informed consent form\n9. ECOG performance status 0 or 1\n10. 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)\n11. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and Alkaline phosphatase \\<2.5x ULN\n12. 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:\n\nVasectomy Condom with spermicide\n\nPartner use of one of the following methods:\n\nPostmenopausal \\>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.\n\nExclusion Criteria:\n\n1. Prior radiotherapy or surgery for prostate cancer\n2. Ongoing hormonal therapy for prostate cancer or hormone therapy \\<3 months prior to the start of treatment\n3. 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\n4. 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.\n5. Metallic hip implant or any other metallic implant or device that distorts the quality of prostatic MR images.\n6. Study participants who, because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent.\n7. Use of 5 alpha reductase inhibitors (e.g., Finasteride or Dutasteride) within 3 months of screening.\n8. Presence of any metastatic disease.\n9. No evidence of extracapsular extension of disease.\n10. 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.\n11. History of prostate infection within 2 years.\n12. No intercurrent medical condition or circumstances that would preclude prostatectomy.\n13. History of bleeding diathesis or currently on anti-coagulation therapy that cannot be safely discontinued for implant procedure.\n14. 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."}, 'identificationModule': {'nctId': 'NCT06257693', 'briefTitle': 'Enzalutamide Implants (Enolen) in Patients With Prostate Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alessa Therapeutics Inc.'}, 'officialTitle': 'A Phase 1 Study to Establish the Feasibility of Enolen (tm) for the Local Delivery of Enzalutamide in Patients With Prostate Cancer', 'orgStudyIdInfo': {'id': 'EP-001'}, 'secondaryIdInfos': [{'id': 'ZIABC011081', 'link': 'https://reporter.nih.gov/quickSearch/ZIABC011081', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Enolen (tm)', 'description': 'Enolen (tm) implants containing enzalutamide', 'interventionNames': ['Drug: enzalutamide']}], 'interventions': [{'name': 'enzalutamide', 'type': 'DRUG', 'otherNames': ['Radical prostatectomy'], 'description': 'Localized single delivery of the Enolen implant (polymer + enzalutamide) with planned radical prostatectomy', 'armGroupLabels': ['Enolen (tm)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jill Harper, PhD RN', 'role': 'CONTACT', 'email': 'jill.harper@nih.gov', 'phone': '240-858-7373'}, {'name': 'Peter Pinto, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Institutes of Health Clinical Center', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}], 'centralContacts': [{'name': 'Bonnie Wettersten, MS', 'role': 'CONTACT', 'email': 'bonnie.wettersten@alessatherapeutics.com', 'phone': '8476449818'}, {'name': 'Pamela Munster, MD', 'role': 'CONTACT', 'email': 'pamela.munster@alessatherapeutics.com', 'phone': '4152166099'}], 'overallOfficials': [{'name': 'Peter Pinto, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Institute (NCI)'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'CSR'], 'timeFrame': 'Data is shared after the completion of the study.', 'ipdSharing': 'YES', 'description': 'Alessa Therapeutics will allow NCI to share data, including genomic data, on this project.', 'accessCriteria': 'Data will be provided by the sponsor/Alessa Therapeutics to the NIH for sharing per the NIH Data Managment and Sharing Policy'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alessa Therapeutics Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}