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NCT04541030 · ClinicalTrials.gov registry record
Integrated Genomic Prostate Score With MRI Targeted Prostate Biopsies
A clinical trial of Prostate Cancer, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- 241
- Enrollment target
- 2
- Study locations
NCT04541030: Active study of Prostate Cancer, sponsored by National Cancer Institute (NCI).
NCT04541030 is a study of Prostate Cancer that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 241 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (60% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04541030, a study of Prostate Cancer, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- 241 participants
- Enrollment target
- 2
- Study locations
Study Summary
Background: Prostate cancer is one of the most common cancers in men. For some men, their cancer is monitored. Others have surgery to remove the prostate. Focal therapy is another treatment option. It treats the areas of cancer selectively, which leaves the rest of the prostate intact. This can help lessen side effects. Men who get focal therapy must be chosen carefully. The Oncotype DX Genomic Prostate Score (GPS) assay tests biopsy samples for certain cancer-related genes. It then then gives a score from 1 to 100 to predict the likelihood of poor outcomes. The GPS is used to choose men for focal therapy. Researchers want to test the GPS further. Objective: To assess how GPS may be useful when used with MRI to improve how men are chosen for focal therapy of prostate cancer. Eligibility: Men age 18 and older who had NCCN low or intermediate risk prostate cancer and had MRI and radical prostatectomy at the Urologic Oncology Branch, National Cancer Institute and collaborating centers. Design: This is a multisite study. It will review data and samples that were collected in the past. Samples and images from up to 277 participants will be used. Tumor tissue will be tested with the GPS. Data such as age at diagnosis, race, biopsy results, and pathology results will be merged with the GPS results. Data will be entered into an in-house electronic system. It will be password protected. All data will be kept in secure sites that comply with NIH security standards.
Primary Outcome
To determine if there is a positive relationship between continuous GPS score and occult high-risk disease on whole mount prostatectomy specimens where an MRI was performed less than 6 months before diagnostic biopsy, and the biopsy was less than 6 months before RP and the lesion was not identified on mpMRI
Conditions Studied
Study Locations (2)
Alabama
- University of Alabama at Birmingham - Birmingham
Maryland
- National Cancer Institute (NCI) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 241 participants |
| Start Date | 2020-09-02 |
| Est. Completion | 2027-07-01 |
What the registry record for NCT04541030 still lists
NCT04541030 is an observational study that tracks outcomes without assigning an intervention. The registered 241 participants enrollment target is mid-sized for trials with a published cap, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (60% lower).
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 0 interventions.
NCT04541030 reports a single indexed study location in Alabama, Maryland.
Frequently Asked Questions
What is clinical trial NCT04541030 about?
NCT04541030 is a clinical study titled "Integrated Genomic Prostate Score With MRI Targeted Prostate Biopsies". Background: Prostate cancer is one of the most common cancers in men. For some men, their cancer is monitored. Others have surgery to remove the prostate. Focal therapy is another treatment option. It treats the areas of cancer selectively, which leaves the rest of the prostate intact. This can hel...
What is the current status of trial NCT04541030?
This trial is currently active not recruiting. The enrollment target is 241 participants. The study started on 2020-09-02. Estimated completion is 2027-07-01.
What conditions does trial NCT04541030 study?
This clinical trial studies the following conditions: Prostate Cancer.
Who is sponsoring clinical trial NCT04541030?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04541030 being conducted?
This trial has 2 study locations across Alabama, 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 NCT04541030's enrollment target sits among peer trials
241 192nd of 735 higher than 544 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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