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NCT06235151 · ClinicalTrials.gov registry record · Phase 3
Copper Cu 64 PSMA I&T PET Imaging in Men With Newly Diagnosed Prostate Cancer
A Phase 3 study of Prostate Cancer and Prostate Adenocarcinoma, sponsored by Curium US.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 439
- Enrollment target
- 20
- Study locations
NCT06235151: Recruiting Phase 3 study of Prostate Cancer and Prostate Adenocarcinoma, sponsored by Curium US.
NCT06235151 is a Phase 3 study of Prostate Cancer and Prostate Adenocarcinoma that is actively recruiting participants, run by Curium US. The registered enrollment target is 439 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (28% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06235151, a Phase 3 study of Prostate Cancer and Prostate Adenocarcinoma, is actively recruiting participants, sponsored by Curium US.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 439 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a prospective, open-label Phase 3 study to evaluate copper Cu 64 PSMA I\&T injection for PET/CT imaging in patients with newly diagnosed unfavorable intermediate high-risk, high-risk or very high-risk prostate cancer.
Primary Outcome
Determine the presence of metastatic pelvic lymph nodes relative to histopathology reference standard. At least one positive pelvic lymph node on the PET scan and one positive lymph node as determined by histopathology on the same side of the pelvis (left or right) will be counted a true positive at the patient level.
Conditions Studied
Interventions
- DRUG Copper Cu 64 PSMA I&T
Study Locations (20)
California
- Providence Medical Foundation - Fullerton
- Tower Urology - Los Angeles
- VA Greater Los Angeles Healthcare System - Los Angeles
- Hoag Memorial Hospital Presbyterian - Newport Beach
- University of California, Irvine - Orange
- San Francisco VA Medical Center - San Francisco
- UCSF Helen Diller Family Comprehensive Cancer Center - San Francisco
- Providence Saint John's Health Center - Santa Monica
- Stanford Hospital & Clinics - Stanford
Florida
- University of Miami Hospital and Clinics - Sylvester Comprehensive Cancer Center - Miami
- CIRA Health - Miami
- Sarasota Memorial Health Care System - Sarasota
- Florida Urology Partners - Tampa
Indiana
- Urology of Indiana, LLC - Carmel
- IU Health Neuroscience Center - Indianapolis
Arkansas
- Arkansas Urology - Little Rock
District of Columbia
- Georgetown University Medical Center - Washington D.C.
Illinois
- Edward Hines Jr. VA Hospital - Hines
Iowa
- University of Iowa - Iowa City
Kansas
- The University of Kansas Hospital - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 439 participants |
| Start Date | 2024-04-01 |
| Est. Completion | 2026-03 |
| Phase | Phase 3 |
What NCT06235151 shows while recruiting
NCT06235151 is an interventional study that assigns participants to a tested intervention. The registered 439 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 (28% lower).
The record links to 2 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 1 intervention - of which Copper Cu 64 PSMA I&T is the first listed.
NCT06235151 names 20 study sites across 8 states, led by California, Florida, Indiana.
Frequently Asked Questions
What is clinical trial NCT06235151 about?
NCT06235151 is a clinical study titled "Copper Cu 64 PSMA I&T PET Imaging in Men With Newly Diagnosed Prostate Cancer". This is a prospective, open-label Phase 3 study to evaluate copper Cu 64 PSMA I\&T injection for PET/CT imaging in patients with newly diagnosed unfavorable intermediate high-risk, high-risk or very high-risk prostate cancer.
What is the current status of trial NCT06235151?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 439 participants. The study started on 2024-04-01. Estimated completion is 2026-03.
What conditions does trial NCT06235151 study?
This clinical trial studies the following conditions: Prostate Cancer, Prostate Adenocarcinoma.
What interventions are being tested in trial NCT06235151?
The interventions under investigation include: Copper Cu 64 PSMA I&T (DRUG).
Who is sponsoring clinical trial NCT06235151?
This trial is sponsored by Curium US, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06235151 being conducted?
This trial has 20 study locations across Arkansas, California, District of Columbia, Florida, Illinois. 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 NCT06235151's enrollment target sits among peer trials
439 126th of 735 higher than 610 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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