Testing a new imaging agent for prostate cancer
A Phase I Trial of 61Cu-NODAGA-PSMA for Patients with Prostate Cancer
PHASE1 · Hoag Memorial Hospital Presbyterian · NCT06736054
This study is testing a new imaging agent for prostate cancer to see if it can help doctors find cancer more effectively during scans.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 8 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Hoag Memorial Hospital Presbyterian (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Irvine, California) |
| Trial ID | NCT06736054 on ClinicalTrials.gov |
What this trial studies
This phase I trial evaluates the safety and effectiveness of a novel molecular imaging radiotracer, 61Cu-NODAGA-PSMA, specifically designed for prostate cancer detection. Participants will receive an intravenous dose of the radiotracer followed by PET/CT imaging to assess its ability to identify PSMA-positive malignant lesions. The study aims to explore the potential of 61Cu as a more widely distributable imaging agent compared to current isotopes. The trial will enroll 6-10 patients and monitor safety and dosimetry, without the expectation of treatment effects.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with biopsy-proven prostate adenocarcinoma and at least one site of PSMA-positive disease.
Not a fit: Patients with known allergies to PSMA-targeted imaging agents or other active malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of prostate cancer imaging and improve patient management.
How similar studies have performed: While this approach is novel, other studies have explored similar imaging techniques, but the use of 61Cu specifically is less common.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Biopsy proven prostate adenocarcinoma 2. Age ≥ 18 years 3. ECOG 0 or 1 4. At least one site of PSMA-positive disease on a PSMA-targeted PET/CT performed within 30 days of trial recruitment 5. Creatinine of ≤1.4 or Creatinine Clearance or ≥ 60 mL/minute. Exclusion Criteria: 1. Known allergy/hypersensitivity to PSMA-targeted imaging agents 2. Other active malignancy, other than the known prostate cancer
Where this trial is running
Irvine, California
- Hoag Memorial Hospital Presbyterian — Irvine, California, United States (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prostate Adenocarcinoma, PSMA, PET/CT, Phase 1