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New treatment option for Prostate Adenocarcinoma
Official title Enzalutamide Implants (Enolen) in Patients With Prostate Cancer
ClinicalTrials.gov ID: NCT06257693
What this study is testing
What is enzalutamide?
enzalutamide is an investigational medicine, being studied as a potential treatment for prostate adenocarcinoma.
Also referred to as Radical prostatectomy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study is to assess whether the Enolen is safe and delivers anti-androgen medication locally in patients that are planning for radical prostatectomy.
- Phase 1: an early, usually small safety study
- Time commitment: about 24 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older, men only
You may be able to join if
- 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
You likely can't join if
- 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...
- Study participant unwilling or unable to undergo MRI, including participants with contra-indications to MRI, such as cardiac pacemakers...
- Metallic hip implant or any other metallic implant or device that distorts the quality of prostatic MR images.
- Study participants who, because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent.
See the full eligibility 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
- 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...
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and Alkaline phosphatase \<2.5x ULN
- 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...
- 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)...
- 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.
- Metallic hip implant or any other metallic implant or device that distorts the quality of prostatic MR images.
- Study participants who, because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent.
- Presence of any metastatic disease.
- No evidence of extracapsular extension of disease.
- 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.
- History of prostate infection within 2 years.
- No intercurrent medical condition or circumstances that would preclude prostatectomy.
- History of bleeding diathesis or currently on anti-coagulation therapy that cannot be safely discontinued for implant procedure.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
- Metairie, Louisiana, United States
- Bethesda, Maryland, United States
- Portland, Oregon, United States
- Myrtle Beach, South Carolina, United States
- Richmond, Virginia, United States
- Milwaukee, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 24 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling male, 21 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States; Metairie, Louisiana, United States; Bethesda, Maryland, United States; Portland, Oregon, United States; Myrtle Beach, South Carolina, United States; Richmond, Virginia, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.