Enzalutamide Implants for Prostate Cancer
This study is testing a new way to deliver enzalutamide (Enolen implants) directly into the prostate for men with prostate adenocarcinoma (a type of prostate cancer). The goal is to see if these implants are safe and if they can deliver the medication locally. You might be able to join if you are at least 21 years old, have confirmed prostate cancer, and are planning to have a radical prostatectomy (surgery to remove the prostate). The study will look at any side effects from the implants and how the medication moves through your body for up to 12 months. The current status of this study is unclear, and it plans to enroll up to 56 participants.
- Study design
- This is an open-label study, meaning you and your doctors will know which treatment you are receiving. It plans to enroll up to 56 participants.
- What's involved
- You will have an MRI, then receive the Enolen implants, followed by a prostatectomy 6-12 weeks or 4-12 months later. You will be followed for 2-6 weeks after surgery, and then for an additional 6-12 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 12 months to assess side effects and medication levels, and for 2-6 weeks post-prostatectomy, then an additional 6-12 weeks post-surgery.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Enzalutamide Implants (Enolen) in Patients With Prostate Cancer
At a glance
Conditions
Where it's being run
10 sites across 8 statesStudy leadership
- Peter Pinto, MD · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- To assess the adverse events associated with the Enolen implantup to 12 months
Using Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v.5.0).
- Measurement of Pharmacokinetics Profileup to 12 months
Enzalutamide plasma (ng/ml), tissue levels (ng/gm) and optional seminal fluid levels (ng/ml)