Enzalutamide Implants (Enolen) in Patients With Prostate Cancer

Part of paid clinical trials in Fresno, California.

Sponsor
Alessa Therapeutics Inc.
Study ID
NCT06257693
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Prostate Adenocarcinoma

Eligibility Criteria

Sex
MALE
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

First listed
Feb 14, 2024
Start date
Jun 21, 2024
Status verified
Aug 2026
Primary completion
Dec 30, 2028
Completion
Dec 30, 2028

Study Design

Enrollment
45 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Enolen (tm)
    Enolen (tm) implants containing enzalutamide

Primary Outcome Measure

To assess the adverse events associated with the Enolen implant [ Time Frame: up to 12 months ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Urology Associates of Central CaliforniaFresnoCalifornia93720
Kristin Santeufemia
[email protected]
559-321-2924
Willian Schiff, MD (PRINCIPAL_INVESTIGATOR)
University of California San Francisco Helen Diller Family Comprehensive Cancer CenterSan FranciscoCalifornia94158
Imelda Tenggara
[email protected]
415-353-7348
Hao Nguyen, MD (PRINCIPAL_INVESTIGATOR)
Northwestern UniversityChicagoIllinois60611
Sophia Kallas
[email protected]
312-694-0633
Ashley Ross, MD (PRINCIPAL_INVESTIGATOR)
Mary Bird Cancer CenterMetairieLouisiana70002
Scott Delacroix, MD (PRINCIPAL_INVESTIGATOR)
Johns Hopkins University School of MedicineBaltimoreMaryland21287
Rana Harb
[email protected]
410-502-2276
George Metri
[email protected]
410-502-2276
Arvin George, MD (PRINCIPAL_INVESTIGATOR)
National Institutes of Health Clinical CenterBethesdaMaryland20892
Katie Evans, RN
[email protected]
240-401-2157
Peter Pinto, MD (PRINCIPAL_INVESTIGATOR)
VA Portland Health Care SystemPortlandOregon97239
Laura Onstad
[email protected]
503-721-1060
Ryan Kopp, MD (PRINCIPAL_INVESTIGATOR)
Atlantic Urology SpecialistsMyrtle BeachSouth Carolina29572
Taylor Stephenson
[email protected]
843-449-1010
Abhishek Srivastava, MD (PRINCIPAL_INVESTIGATOR)
Virginia Commonwealth UniversityRichmondVirginia23298
Genelle Gaudinez
[email protected]
804-628-6430
Alexander Kenigsberg, MD (PRINCIPAL_INVESTIGATOR)
Aurora UrologyMilwaukeeWisconsin53215
Greg Anderson
[email protected]
262-442-9368
Zachary Kozel, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Fresno, CA

By research site
Urology Associates of Central California· Fresno, CAUniversity of California San Francisco Helen Diller Family Comprehensive Cancer Center· San Francisco, CANorthwestern University· Chicago, ILMary Bird Cancer Center· Metairie, LAJohns Hopkins University School of Medicine· Baltimore, MDNational Institutes of Health Clinical Center· Bethesda, MD

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