NCT07635524Not yet recruitingPhase 2
A Phase 2 Trial of 61Cu-NU101 PET/CT Compared Against Current Standard-of-care 18F-piflufolastat (Pylarify®) PET/CT.
A Two Center Phase 2 Trial of 61Cu-noDAGa-PSMA I&T (61Cu-NU101) for Patients With Prostate Cancer
Source: ClinicalTrials.gov · Last updated 9 Jun 2026
Brief summary (registry, in English)
The purpose of this research is to test whether a new investigational Molecular Imaging (MI) agent called 61Cu-NU101 is equal to or better than a currently used MI agent, Pylarify, for the detection of prostate cancer metastases. 34 participants with biopsy-proven prostate cancer and cancer seen on a Pylarify PET scan will be enrolled in this study. The investigational 61Cu-NU101 PET/CT will be perfromed. If there is a difference between the standard Pylarify exam and the investigational 61Cu-NU101 exam, a biopsy of one lesion that is different between the two exams may be performed.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 34 (estimated)
- First submitted
- 3 Jun 2026
- Start date
- 1 Aug 2026
- Primary completion date
- 1 Aug 2028
- Lead sponsor
- Hoag Memorial Hospital Presbyterian
- Diseases
- Prostate cancer
- NCT number
- NCT07635524
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 34
- From 1 Aug 2026 to the primary completion date, 1 Aug 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Known allergy/hypersensitivity to PSMA-targeted imaging agents
- Other active malignancy, other than the known prostate cancer
Who the study is looking for
- Biopsy proven prostate adenocarcinoma
- Age ≥ 18 years
- ECOG 0 or 2 4 .Oligometastatic disease (1-5 radiotracer avid disease sites) on 18F- piflufolastat PET/CT within 30 days of trial recruitment
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hoag Family Cancer Institute Coordinator of this site? Confirm its status | Newport Beach | United States | Unknown status |
| Washington Univeristy School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.