NCT06736054 A Phase I Trial of 61Cu-NODAGA-PSMA for Patients with Prostate Cancer
| NCT ID | NCT06736054 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Hoag Memorial Hospital Presbyterian |
| Condition | Prostate Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 8 participants |
| Start Date | 2024-10-14 |
| Primary Completion | 2025-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 8 participants in total. It began in 2024-10-14 with a primary completion date of 2025-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Molecular Imaging (MI) uses tracers which emit radiation to provide clinically valuable imaging for patient with cancer. Most current MI agents utilize Fluorine 18 or Gallium 68 as the positron emitter for PET imaging. However, these isotopes have short half-lives which limit the geographic distribution range of tracers made with these isotopes. Copper 61 (61Cu) has a 3.3 hour half-life, which would allow for far greater distribution range following radiotracer production. This phase I trial will test the safety and effectiveness of a novel MI radiotracer that uses 61Cu as its positron emitting isotope and targets Prostate Specific Membrane Antigen (PSMA) for imaging prostate cancer. A successful trial will provide the ability to advance this novel 61Cu-NODAGA-PSMA radioisotope into phase II trials, as well as open a new paradigm into the production of MI radioisotopes with 61Cu.
Eligibility 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
Frequently Asked Questions
Who can join the NCT06736054 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06736054 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06736054 currently recruiting?
Yes, NCT06736054 is actively recruiting participants. Visit ClinicalTrials.gov or contact Hoag Memorial Hospital Presbyterian to inquire about joining.
Where is the NCT06736054 trial being conducted?
This trial is being conducted at Irvine, United States.
Who is sponsoring the NCT06736054 clinical trial?
NCT06736054 is sponsored by Hoag Memorial Hospital Presbyterian. The trial plans to enroll 8 participants.