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NCT06389786 · ClinicalTrials.gov registry record · NA
Accuracy of 18F-rhPSMA-7.3 PET/ MRI for Prediction of Lymph Node Metastasis in Localized High-Risk Prostate Cancer
A NA study of Stage III Prostate Cancer AJCC v8 and Stage IVA Prostate Cancer AJCC v8, sponsored by Mayo Clinic.
- Recruiting
- Registry status
- NA
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT06389786: Recruiting NA study of Stage III Prostate Cancer AJCC v8 and Stage IVA Prostate Cancer AJCC v8, sponsored by Mayo Clinic.
NCT06389786 is a NA study of Stage III Prostate Cancer AJCC v8 and Stage IVA Prostate Cancer AJCC v8 that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 50 participants, below the 247-participant average among 28 other Stage III Prostate Cancer AJCC v8 trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06389786, a NA study of Stage III Prostate Cancer AJCC v8 and Stage IVA Prostate Cancer AJCC v8, is actively recruiting participants, sponsored by Mayo Clinic.
- RECRUITING
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
This clinical trial evaluates the use of an imaging scan (18F-rhPSMA-7.3 positron emission tomography \[PET\]/magnetic resonance imaging \[MRI\]) for identifying patients who are at risk of having their disease spread to the lymph nodes in those undergoing radical prostatectomy for prostate cancer that has not spread to other parts of the body (localized). Prostate specific membrane antigen (PSMA) PET/computed tomography (CT) has emerged as an option to stage newly diagnosed high risk prostate cancer patients. PSMA PET/CT has demonstrated improved diagnostic accuracy for identifying metastasis. PET is procedure in which a small amount of radioactive glucose (sugar) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the glucose is used. Because cancer cells often use more glucose than normal cells, the pictures can be used to find cancer cells in the body. MRI is procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body. These pictures can show the difference between normal and diseased tissue. This study may help researchers learn whether 18F-rhPSMA-7.3 PET/ MRI may improve predicting which patients are at risk of lymph node metastases and who are suitable candidates for pelvic lymph node dissection in patients with localized high-risk prostate cancer undergoing radical prostatectomy.
Primary Outcome
Defined as the presence of lymph node positivity determined on final pathologic analysis compared to findings on preoperative 18F-rhPSMA-7.3 PSMA PET/MRI. Continuous variables will be summarized as mean (standard deviation) or median (range) while categorical variables will be reported as frequency (percentage).
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Bone Scan
- OTHER Electronic Health Record Review
- PROCEDURE Bilateral Pelvic Lymph Node Dissection
Study Locations (1)
Florida
- Mayo Clinic in Florida - Jacksonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2024-06-11 |
| Est. Completion | 2026-05 |
| Phase | NA |
What NCT06389786 shows while recruiting
NCT06389786 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 247-participant average among 28 other Stage III Prostate Cancer AJCC v8 trials with a reported enrollment target (80% lower).
The record links to 6 conditions, with Stage III Prostate Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06389786 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT06389786 about?
NCT06389786 is a clinical study titled "Accuracy of 18F-rhPSMA-7.3 PET/ MRI for Prediction of Lymph Node Metastasis in Localized High-Risk Prostate Cancer". This clinical trial evaluates the use of an imaging scan (18F-rhPSMA-7.3 positron emission tomography \[PET\]/magnetic resonance imaging \[MRI\]) for identifying patients who are at risk of having their disease spread to the lymph nodes in those undergoing radical prostatectomy for prostate cancer t...
What is the current status of trial NCT06389786?
This trial is currently recruiting. It is a NA study. The enrollment target is 50 participants. The study started on 2024-06-11. Estimated completion is 2026-05.
What conditions does trial NCT06389786 study?
This clinical trial studies the following conditions: Stage III Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage I Prostate Cancer AJCC v8, Localized Prostate Carcinoma.
What interventions are being tested in trial NCT06389786?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Bone Scan (PROCEDURE), Electronic Health Record Review (OTHER), Bilateral Pelvic Lymph Node Dissection (PROCEDURE).
Who is sponsoring clinical trial NCT06389786?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06389786 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
Similar trials for Stage III Prostate Cancer AJCC v8
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 NCT06389786's enrollment target sits among peer trials
50 20th of 28 higher than 9 of 28 other Stage III Prostate Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage III Prostate Cancer AJCC v8 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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