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NCT06312670 · ClinicalTrials.gov registry record · Phase 2
Combining EPI-7386 With Enzalutamide and Androgen Deprivation Therapy for Metastatic Hormone-Sensitive Prostate Cancer
A Phase 2 study of Prostate Cancer and Prostate Adenocarcinoma, sponsored by Pedro Barata, MD, MSc.
- Completed
- Registry status
- Phase 2
- Development phase
- 13
- Enrollment target
- 2
- Study locations
NCT06312670: Completed Phase 2 study of Prostate Cancer and Prostate Adenocarcinoma, sponsored by Pedro Barata, MD, MSc.
NCT06312670 is a Phase 2 study of Prostate Cancer and Prostate Adenocarcinoma that has completed, run by Pedro Barata, MD, MSc. The registered enrollment target is 13 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06312670, a Phase 2 study of Prostate Cancer and Prostate Adenocarcinoma, has completed, sponsored by Pedro Barata, MD, MSc.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 13 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to study the effects of EPI-7386 in combination with Enzalutamide on participants diagnosed with prostate cancer. The main goals of this study are to evaluate the antitumor activity of EPI-7386 in combination with enzalutamide in metastatic hormone-sensitive prostate cancer (mHSPC), and to evaluate the pharmacokinetics (PK) of EPI-7386 when dosed in combination with enzalutamide. Participants will will take the study drug, EPI-7360, twice a day by mouth and enzalutamide once a day by mouth, alongside clinic visits every two weeks.
Primary Outcome
Defined as prostate-specific antigen (PSA) undetectable (\<0.2 ng/mL) at 6 months after treatment. The true BRR for the study population will be estimated based on the number of biochemical responses using a binomial distribution, and its confidence interval (CI) will be estimated using Wilson's method.
Conditions Studied
Interventions
- DRUG Enzalutamide
- DRUG Androgen Deprivation Therapy (ADT)
- DRUG EPI-7386
Study Locations (2)
Ohio
- University Hospitals Cleveland Medical Center Seidman Cancer Center, Case Comprehensive Cancer Center - Cleveland
- Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2024-05-16 |
| Est. Completion | 2025-01-09 |
| Phase | Phase 2 |
What the finished NCT06312670 record still lists
NCT06312670 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (98% lower).
The record links to 3 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 3 interventions - of which Enzalutamide is the first listed.
NCT06312670 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT06312670 about?
NCT06312670 is a clinical study titled "Combining EPI-7386 With Enzalutamide and Androgen Deprivation Therapy for Metastatic Hormone-Sensitive Prostate Cancer". The purpose of this study is to study the effects of EPI-7386 in combination with Enzalutamide on participants diagnosed with prostate cancer. The main goals of this study are to evaluate the antitumor activity of EPI-7386 in combination with enzalutamide in metastatic hormone-sensitive prostate can...
What is the current status of trial NCT06312670?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2024-05-16. Estimated completion is 2025-01-09.
What conditions does trial NCT06312670 study?
This clinical trial studies the following conditions: Prostate Cancer, Prostate Adenocarcinoma, Metastatic Hormone-Sensitive Prostate Cancer (mHSPC).
What interventions are being tested in trial NCT06312670?
The interventions under investigation include: Enzalutamide (DRUG), Androgen Deprivation Therapy (ADT) (DRUG), EPI-7386 (DRUG).
Who is sponsoring clinical trial NCT06312670?
This trial is sponsored by Pedro Barata, MD, MSc, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06312670 being conducted?
This trial has 2 study locations across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06312670's enrollment target sits among peer trials
13 698th of 735 higher than 34 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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