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NCT02430480 · ClinicalTrials.gov registry record · Phase 2
Using Multiparametric MRI to Evaluate Intraprostatic Tumor Responses and Androgen Resistance Patterns in Newly Diagnosed Prostate Cancer
A Phase 2 study of Prostate Cancer, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 39
- Enrollment target
- 1
- Study location
NCT02430480: Completed Phase 2 study of Prostate Cancer, sponsored by National Cancer Institute (NCI).
NCT02430480 is a Phase 2 study of Prostate Cancer that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 39 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02430480, a Phase 2 study of Prostate Cancer, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 39 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: * There are several ways to treat prostate cancer. Researchers want to see how well a certain kind of imaging helps detect prostate cancer. They also want to see if a particular drug combination used before surgery will benefit people with prostate cancer that hasn't spread in the body (non-metastatic). The combination will be androgen deprivation therapy and enzalutamide. * The combination of androgen deprivation therapy and enzalutamide has been shown to make patients with advanced (metastatic disease) live longer. The investigators want to see if using it earlier can increase cure rate of surgery and identify genetic or molecular characteristics that are associated with better outcomes. Objectives: \- To develop better ways of detecting prostate cancer before and after pre-operative treatment. Eligibility: \- Men at least 18 years old with non-metastatic prostate cancer. They must be candidates for a radical prostatectomy. Design: * Participants will be screened with medical history, physical exam, and blood tests. They will have scans and X-rays. * Before starting the study drugs, participants will have: * Vital signs taken, medical history, and blood tests. * Electrocardiogram (ECG) heart test, with patches stuck on the skin. * Small piece of tumor removed (biopsy) using image guidance from magnetic resonance imaging (MRI) and ultrasound. * 3T multi-parametric magnetic resonance imaging (mpMRI). Participants will lie on a table that slides into a metal cylinder. A probe will be inserted in the rectum. They will be in the scanner for about 60 minutes, lying still. The scanner makes loud knocking sounds. Participants will get earplugs. * Participants will take the 2 study drugs for 6 months. * Enzalutamide is taken as 4 pills once a day. * Androgen deprivation therapy is given by injection 2 times over 6 months. * During these 6 months, participants will visit the clinic monthly. They will have physical exam, vital signs, and blood drawn. * Aft
Primary Outcome
The prostate lesion is contoured manually by an expert radiologist. Research software (mim-vista) calculates the volume. Greater tumor volumes may indicate higher prostate tumor growth.
Conditions Studied
Interventions
- DRUG Goserelin
- DRUG Enzalutamide
- DEVICE mpMRI
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2015-06-03 |
| Est. Completion | 2024-06-11 |
| Phase | Phase 2 |
What the finished NCT02430480 record still lists
NCT02430480 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 3 interventions - of which Goserelin is the first listed.
NCT02430480 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT02430480 about?
NCT02430480 is a clinical study titled "Using Multiparametric MRI to Evaluate Intraprostatic Tumor Responses and Androgen Resistance Patterns in Newly Diagnosed Prostate Cancer". Background: * There are several ways to treat prostate cancer. Researchers want to see how well a certain kind of imaging helps detect prostate cancer. They also want to see if a particular drug combination used before surgery will benefit people with prostate cancer that hasn't spread in the body ...
What is the current status of trial NCT02430480?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 39 participants. The study started on 2015-06-03. Estimated completion is 2024-06-11.
What conditions does trial NCT02430480 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT02430480?
The interventions under investigation include: Goserelin (DRUG), Enzalutamide (DRUG), mpMRI (DEVICE).
Who is sponsoring clinical trial NCT02430480?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02430480 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
Similar trials for Prostate Cancer
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 NCT02430480's enrollment target sits among peer trials
39 536th of 735 higher than 199 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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