Phase 2
N=26
Cu-64-PSMA-I&T Positron Emission Tomography (PET) Imaging of Metastatic PSMA Positive Lesions in Men With Prostate Cancer
Metastasis From Malignant Tumor of Prostate (Disorder)
Bottom Line
View on ClinicalTrials.gov: NCT05653856 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Region-Level Correct Localization Rate (CLR) — 86.67; 86.67; 76.67; 80.00 percentage of Regions
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 64Cu-PSMA I&T (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Curium US LLC
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Region-Level Correct Localization Rate (CLR) |
86.67; 86.67; 76.67; 80.00; 80.00; 80.00 | — |
| PRIMARY Patient-Level Correct Detection Rate (CDR) |
84.21; 84.21; 77.19; 79.82; 80.70; 80.70 | — |
| PRIMARY Incidence of Adverse Events |
3; 0 | — |
| SECONDARY Score of Image Quality |
0; 0; 26; 0; 0; 26 | — |
Summary
This is a prospective, open-label Phase 2 study to evaluate copper Cu 64 PSMA I&T injection for PET/CT imaging in patients with recurrent metastatic prostate cancer after radical prostatectomy or radiation therapy.
Eligibility Criteria
Inclusion Criteria
- Patients with histologically proven prostate adenocarcinoma.
- Prior radical prostatectomy or radiation therapy with curative intent.
- Recurrence of disease defined as:
- Prior Radical Prostatectomy: PSA > 0.2 ng/mL, or
- Prior Radiation Therapy: 2 ng/mL rise in PSA over post-treatment nadir
- Patients with at least one extraprostatic site of disease suspected based on prior imaging or diagnosed by biopsy.
- Age greater than or equal to 18 years.
- Able to understand and provide signed written informed consent.
Exclusion Criteria
- Androgen deprivation therapy (ADT) or other therapies targeting the androgen pathway, unless subject has a rising PSA level.
- Body weight greater than 350 lb (158 kg).
- Investigational therapy within the past 30 days.
- Creatinine clearance (ClCr) less than 30 mL/min.
- Participants who are capable of fathering a child and who are unwilling to take precautions to prevent pregnancy.
Data sourced from ClinicalTrials.gov (NCT05653856). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.