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NCT01411345 · ClinicalTrials.gov registry record · NA
MRI-Mapped Dose-Escalated Salvage Radiotherapy Post-Prostatectomy: The MAPS Trial
A NA study of Prostate Cancer and Prostate Adenocarcinoma, sponsored by University of Miami.
- Active
- Registry status
- NA
- Development phase
- 37
- Enrollment target
- 1
- Study location
NCT01411345: Active NA study of Prostate Cancer and Prostate Adenocarcinoma, sponsored by University of Miami.
NCT01411345 is a NA study of Prostate Cancer and Prostate Adenocarcinoma that is active but no longer recruiting, run by University of Miami. The registered enrollment target is 37 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
NCT01411345, a NA study of Prostate Cancer and Prostate Adenocarcinoma, is active but no longer recruiting, sponsored by University of Miami.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 37 participants
- Enrollment target
- 1
- Study location
Study Summary
1. The investigators hypothesize that increasing radiation dose to the functional MRI-defined lesion in the prostate bed will result in an improved initial complete response (reduction in prostate-specific antigen (PSA) to \< 0.1 ng/mL), which is related to long-term outcome biochemically. 2. Biomarker expression levels differ in the DCE-MRI enhancing and non-enhancing tumor regions (when applicable). 3. 10-15% of men undergoing RT have free circulating DNA (fcDNA) or tumor cells (CTC) that are related to an adverse treatment outcome. 4. Prostate cancer-related anxiety will be reduced in the MRI targeted SRT arm, because the patients will be aware that the dominant tumor will be targeted with higher radiation dose (compared to those pts who were treated on standard arm prior to its closure).
Primary Outcome
Prostate-Specific Antigen (PSA) response rate is defined as the percentage of study patients with PSA less than 0.1 ng/mL at 21 months after completion of study treatment.
Conditions Studied
Interventions
- RADIATION Standard Salvage Radiation Treatment (SSRT)
- RADIATION Mapped Tumor Salvage RT (MTSRT)
Study Locations (1)
Florida
- University of Miami - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2012-07-12 |
| Est. Completion | 2028-02-13 |
| Phase | NA |
What the registry record for NCT01411345 still lists
NCT01411345 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 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 2 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which Standard Salvage Radiation Treatment (SSRT) is the first listed.
NCT01411345 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT01411345 about?
NCT01411345 is a clinical study titled "MRI-Mapped Dose-Escalated Salvage Radiotherapy Post-Prostatectomy: The MAPS Trial". 1. The investigators hypothesize that increasing radiation dose to the functional MRI-defined lesion in the prostate bed will result in an improved initial complete response (reduction in prostate-specific antigen (PSA) to \< 0.1 ng/mL), which is related to long-term outcome biochemically. 2. Biomar...
What is the current status of trial NCT01411345?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 37 participants. The study started on 2012-07-12. Estimated completion is 2028-02-13.
What conditions does trial NCT01411345 study?
This clinical trial studies the following conditions: Prostate Cancer, Prostate Adenocarcinoma.
What interventions are being tested in trial NCT01411345?
The interventions under investigation include: Standard Salvage Radiation Treatment (SSRT) (RADIATION), Mapped Tumor Salvage RT (MTSRT) (RADIATION).
Who is sponsoring clinical trial NCT01411345?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01411345 being conducted?
This trial has 1 study location across Florida. 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 NCT01411345's enrollment target sits among peer trials
37 541st of 735 higher than 193 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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