A Phase 1 Study to Establish the Feasibility of Enolen (tm) for the Local Delivery of Enzalutamide in Patients With Prostate Cancer
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 multi-center, open-label feasibility study. Up to 56 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 followed by a standard of care prostatectomy 6-12 weeks or 4-12 months post-implant procedure. Twenty participants in Cohort A receive up to 16 implants and have a prostatectomy planned between weeks 6 and 12 post-implant procedure. Twenty-four participants in Cohort B are randomized to 8 or 16 implants and have a prostatectomy planned between weeks 6 and 12 post-implant procedure. Twelve participants in Cohort C receive 16 implants and have a prostatectomy planned between months 4 and 12 post-implant procedure. If the participant is unwilling to undergo the prostatectomy by 12 months, they must agree to close monitoring with imaging by MRI every three months and biopsies, as indicated, for up to 24 months post-implant procedure. Study participants are followed for 2-6 weeks post-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.
Arms & interventions
- Drugenzalutamide
Localized single delivery of the Enolen implant (polymer + enzalutamide) with planned radical prostatectomy
Outcome measures
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).
Time frame: up to 12 months
Measurement of Pharmacokinetics Profile
Enzalutamide plasma (ng/ml) and tissue levels (ng/gm)
Time frame: up to 12 months
Secondary
MRI changes
Time frame: up to 12 months post Enolen implantation
Changes in Prostate-specific antigen (PSA)
Time frame: 6 to 12 weeks post radical prostatectomy
Changes in Testosterone
Time frame: 6 to 12 weeks post Enolen implantation
Eligibility criteria
Study locations (7)
Northwestern University
Chicago, Illinois, 60611
Mary Bird Cancer Center
Metairie, Louisiana, 70002
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
VA Portland Health Care System
Portland, Oregon, 97239
Atlantic Urology Specialists
Myrtle Beach, South Carolina, 29572
Virginia Commonwealth University
Richmond, Virginia, 23298
Aurora Urology
Milwaukee, Wisconsin, 53215