RecruitingPhase 1

Enzalutamide Implants (Enolen) in Patients With Prostate Cancer

United States45 participantsStarted 2024-06-21

Plain-language 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.

Who can participate

Age range

21 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age at least 21 years old
. Histologically confirmed adenocarcinoma of the prostate
. Study participant qualified and planning for radical prostatectomy
. At least 1 prostate lesion measurable by MRI greater or equal to 0.5 cm
. Cohort A and Cohort B: Gleason score 3+4 or higher Cohort C: Gleason score 3+3 with high risk features or 3+4
. Study participant must be willing to undergo post-treatment imaging by MRI
. Participants must be able to understand and sign the informed consent form
. ECOG performance status 0 or 1

Exclusion criteria

. Prior radiotherapy or surgery for prostate cancer
. Ongoing hormonal therapy for prostate cancer or hormone therapy \<3 months prior to the start of treatment
. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To assess the adverse events associated with the Enolen implant

Timeframe: up to 12 months

Measurement of Pharmacokinetics Profile

Timeframe: up to 12 months

Trial details

NCT IDNCT06257693

SponsorAlessa Therapeutics Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-12-30

Contact for this trial

Bonnie Wettersten, MS

847-644-9818 bonnie.wettersten@alessatherapeutics.com

View on ClinicalTrials.gov More Prostate Adenocarcinoma trials