Enzalutamide Implants for Prostate Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot have ongoing hormonal therapy for prostate cancer or use 5 alpha reductase inhibitors within 3 months of starting the trial.
What data supports the effectiveness of the drug Enzalutamide for prostate cancer?
Research shows that Enzalutamide, when used for prostate cancer, significantly improves survival rates and reduces cancer markers in patients, especially those with castration-resistant prostate cancer. It has been shown to prolong survival compared to older treatments and is well-tolerated in clinical trials.12345
Is enzalutamide generally safe for humans?
How is the drug enzalutamide unique for prostate cancer treatment?
Enzalutamide is unique because it is an androgen receptor inhibitor that blocks several steps in the androgen receptor signaling pathway, which is crucial for prostate cancer progression. Unlike traditional treatments, it is administered orally and has been shown to significantly improve survival rates and delay the need for chemotherapy in men with metastatic castration-resistant prostate cancer.12389
What is the purpose of this trial?
The study is to assess whether the Enolen is safe and delivers anti-androgen medication locally in patients that are planning for radical prostatectomy.
Research Team
Peter Pinto, MD
Principal Investigator
National Cancer Institute (NCI)
Eligibility Criteria
Men over 21 with prostate cancer, a Gleason score of at least 3+4, and PSA levels ≥3 ng/mL. They must be fit for surgery, have no history of prostate infection in the last two years or hormonal therapy within three months. No metallic implants that affect MRI quality or conditions preventing surgery are allowed.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Baseline
Participants undergo multiparametric MRI of the prostate
Treatment
Placement of drug eluting Enolen implants and follow-up MRI
Surgery
Participants undergo standard of care radical prostatectomy
Follow-up
Participants are monitored for safety and effectiveness after surgery, including clinical labs and quality of life questionnaires
Treatment Details
Interventions
- Enzalutamide
Enzalutamide is already approved in United States, European Union, Canada, Japan for the following indications:
- Metastatic castration-resistant prostate cancer (mCRPC)
- Non-metastatic castration-resistant prostate cancer (nmCRPC)
- Metastatic castration-resistant prostate cancer (mCRPC)
- Non-metastatic castration-resistant prostate cancer (nmCRPC)
- Metastatic castration-resistant prostate cancer (mCRPC)
- Non-metastatic castration-resistant prostate cancer (nmCRPC)
- Metastatic castration-resistant prostate cancer (mCRPC)
- Non-metastatic castration-resistant prostate cancer (nmCRPC)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alessa Therapeutics Inc.
Lead Sponsor
National Cancer Institute (NCI)
Collaborator