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NCT03860987 · ClinicalTrials.gov registry record · Phase 2
Neoadjuvant Androgen Deprivation Therapy Combined With Enzalutamide and Abiraterone Using Multiparametric MRI and 18FDCFPyL PET/CT in Newly Diagnosed Prostate Cancer
A Phase 2 study of Castrate Sensitive Prostate Cancer, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT03860987: Active Phase 2 study of Castrate Sensitive Prostate Cancer, sponsored by National Cancer Institute (NCI).
NCT03860987 is a Phase 2 study of Castrate Sensitive Prostate Cancer that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 12 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03860987, a Phase 2 study of Castrate Sensitive Prostate Cancer, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Prostate cancer is a common cancer among men. There are several ways to treat it, including hormone blocking drugs, radiation therapy, and surgery. Researchers want to combine abiraterone and enzalutamide to see if there is a better way to treat prostate cancer. They also want to study a new radiotracer called 18F-DCFPyL, with the help of a scan called positron emission tomography/computed tomography (PET/CT) to see if there is a better way to detect prostate cancer. Objective: To develop improved techniques to localize and detect prostate cancer; and to develop new ways to treat prostate cancer Eligibility: Men ages 18 and older with prostate cancer that has not spread to other parts of the body Design: * Participants will have a medical evaluation to determine eligibility for the study. * Participants will take three different medications daily by mouth and receive two injections during the course of the study. * Participants will have a medical evaluation monthly (for 6 months) while taking the medications. * Participants will have prostate MRI and PET/CT scans before treatment, 2 months after starting treatment and again before surgery. The radiotracer will be given by injection about 2 hours before the whole-body scan. The PET/CT scan itself is about an hour. * Participants may be asked to do a biopsy before treatment and 2 months after starting treatment. * Participants will have a full medical evaluation before surgery to remove their prostate. * Participants will have a follow-up visit 3 months after surgery and then as needed. * Participants will be contacted once a year for their PSA and testosterone levels for 5 years...
Primary Outcome
The primary endpoint will be the disease status after completion of treatment relative to PSMA-PET imaging findings at 2 months
Conditions Studied
Interventions
- DRUG Prednisone
- DRUG Enzalutamide
- DRUG Abiraterone
- DRUG goserelin
- DRUG 18F-DCFPyL
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2019-04-30 |
| Est. Completion | 2028-08-01 |
| Phase | Phase 2 |
What the registry record for NCT03860987 still lists
NCT03860987 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Castrate Sensitive Prostate Cancer appearing as the primary indexed condition, and to 5 interventions - of which Prednisone is the first listed.
NCT03860987 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT03860987 about?
NCT03860987 is a clinical study titled "Neoadjuvant Androgen Deprivation Therapy Combined With Enzalutamide and Abiraterone Using Multiparametric MRI and 18FDCFPyL PET/CT in Newly Diagnosed Prostate Cancer". Background: Prostate cancer is a common cancer among men. There are several ways to treat it, including hormone blocking drugs, radiation therapy, and surgery. Researchers want to combine abiraterone and enzalutamide to see if there is a better way to treat prostate cancer. They also want to study ...
What is the current status of trial NCT03860987?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2019-04-30. Estimated completion is 2028-08-01.
What conditions does trial NCT03860987 study?
This clinical trial studies the following conditions: Castrate Sensitive Prostate Cancer.
What interventions are being tested in trial NCT03860987?
The interventions under investigation include: Prednisone (DRUG), Enzalutamide (DRUG), Abiraterone (DRUG), goserelin (DRUG), 18F-DCFPyL (DRUG).
Who is sponsoring clinical trial NCT03860987?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03860987 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03860987's enrollment target sits among peer trials
12 1948th of 2000 higher than 34 of 2,000 other Phase 2 trials
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