Enzalutamide Implants (Enolen) in Patients With Prostate Cancer
A Phase 1 Study to Establish the Feasibility of Enolen (tm) for the Local Delivery of Enzalutamide in Patients With Prostate Cancer
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 21 Years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 24 months
- Procedures mentioned: MRI scans, Biopsies, Questionnaires
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "At baseline, patients will undergo multiparametric MRI of the prostate."
- "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."
- "Clinical labs and correlative sample collection and patient quality of life questionnaires will be administered at follow-up visits."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether Enolen implants are safe and can deliver medicine that blocks male hormones directly to the prostate. It is for people with prostate cancer who plan to have surgery to remove the prostate.
The study is to assess whether the Enolen is safe and delivers anti-androgen medication locally in patients that are planning for radical prostatectomy.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be at least 21 and have prostate adenocarcinoma, a type of cancer confirmed by a tissue test.
- Be able to have surgery to remove the prostate and plan to have it.
- Have at least one cancer spot measuring 0.5 cm or more on an MRI scan. Agree to another MRI after treatment.
- Meet the cancer grade rules: groups A and B need a Gleason score of 3+4 or higher. Group C needs 3+3 with high-risk features, or 3+4. This score describes how abnormal the cancer cells look.
- Be able to understand and sign the study consent form.
- Be fully active or able to do light work despite limits on hard physical activity.
- Have blood cell counts and kidney and liver test results that meet the study's limits.
- Agree to use a highly effective birth control method or avoid sex from study entry until 3 months after prostate surgery or implant removal.
Who can't join
- Past radiation or surgery for prostate cancer, or certain past prostate treatments, including treatments for an enlarged prostate.
- Hormone treatment for prostate cancer now or within 3 months before study treatment starts.
- Cannot or will not have an MRI, or have a metal implant or device that makes the prostate images unclear.
- Cannot give valid consent or follow study steps, or have a condition that prevents prostate surgery.
- Cancer that has spread to other parts of the body. The listing also says 'no evidence' of cancer growing beyond the prostate's outer layer is an exclusion; ask the study team to clarify this rule.
- A doctor believes the implant procedure puts you at higher risk of lasting trouble emptying your bladder.
- A prostate infection within the past 2 years.
- A history of bleeding problems, or use of blood thinners that cannot be safely stopped for the implant procedure.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. Age at least 21 years old 2. Histologically confirmed adenocarcinoma of the prostate 3. Study participant qualified and planning for radical prostatectomy 4. At least 1 prostate lesion measurable by MRI greater or equal to 0.5 cm 5. Cohort A and Cohort B: Gleason score 3+4 or higher Cohort C: Gleason score 3+3 with high risk features or 3+4 6. Study participant must be willing to undergo post-treatment imaging by MRI 7. Participants must be able to understand and sign the informed consent form 8. ECOG performance status 0 or 1 9. Adequate organ function, including absolute neutrophil count (ANC) ≥1000 cells/μL, hemoglobin ≥9 g/dL, platelets ≥100,000 cells/μL, estimated creatinine clearance ≥50 mL/min, bilirubin \<1.5x ULN (\< 3x ULN for documented Gilbert's syndrome) 10. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and Alkaline phosphatase \<2.5x ULN 11. 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 time of study entry and continuing through three months after radical prostatectomy/implant removal. Highly effective forms of contraception include: Vasectomy Condom with spermicide Partner use of one of the following methods: Postmenopausal \>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. Exclusion Criteria: 1. Prior radiotherapy or surgery for prostate cancer 2. Ongoing hormonal therapy for prostate cancer or hormone therapy \<3 months prior to the start of treatment 3. 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 4. 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. 5. Metallic hip implant or any other metallic implant or device that distorts the quality of prostatic MR images. 6. Study participants who, because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent. 7. Presence of any metastatic disease. 8. No evidence of extracapsular extension of disease. 9. 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. 10. History of prostate infection within 2 years. 11. No intercurrent medical condition or circumstances that would preclude prostatectomy. 12. History of bleeding diathesis or currently on anti-coagulation therapy that cannot be safely discontinued for implant procedure. 13. 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.
Study sites (10)
CA
- Urology Associates of Central California · Fresno, CA 93720Kristin Santeufemia · Study contact · 559-321-2924 · ksanteufemia@urologyassociates.netWillian Schiff, MD · Principal investigatorMore trials in Fresno
- University of California San Francisco Helen Diller Family Comprehensive Cancer Center · San Francisco, CA 94158Imelda Tenggara · Study contact · 415-353-7348 · imelda.tenggara@ucsf.eduHao Nguyen, MD · Principal investigatorMore trials in San Francisco
IL
- Northwestern University · Chicago, IL 60611Sophia Kallas · Study contact · 312-694-0633 · sophia.kallas@northwestern.eduAshley Ross, MD · Principal investigatorMore trials in Chicago
LA
- Mary Bird Cancer Center · Metairie, LA 70002Mandy Shipp · Study contact · mshipp@marybird.comScott Delacroix, MD · Principal investigatorMore trials in Metairie
MD
- Johns Hopkins University School of Medicine · Baltimore, MD 21287Rana Harb · Study contact · 410-502-2276 · rharb1@jhmi.eduGeorge Metri · Study contact · 410-502-2276 · gmetri1@jh.eduArvin George, MD · Principal investigatorMore trials in Baltimore
- National Institutes of Health Clinical Center · Bethesda, MD 20892Katie Evans, RN · Study contact · 240-401-2157 · katie.evans@nih.govPeter Pinto, MD · Principal investigatorMore trials in Bethesda
OR
- VA Portland Health Care System · Portland, OR 97239Laura Onstad · Study contact · 503-721-1060 · laura.onstad@va.govRyan Kopp, MD · Principal investigatorMore trials in Portland
SC
- Atlantic Urology Specialists · Myrtle Beach, SC 29572Taylor Stephenson · Study contact · 843-449-1010 · taylor.stephenson@startresearch.comAbhishek Srivastava, MD · Principal investigatorMore trials in Myrtle Beach
VA
- Virginia Commonwealth University · Richmond, VA 23298Genelle Gaudinez · Study contact · 804-628-6430 · gaudinezg@vcu.eduAlexander Kenigsberg, MD · Principal investigatorMore trials in Richmond
WI
- Aurora Urology · Milwaukee, WI 53215Greg Anderson · Study contact · 262-442-9368 · gregory.anderson@aah.orgZachary Kozel, MD · Principal investigatorMore trials in Milwaukee