OncoMatch/Clinical Trials/NCT04868604
64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer (SECuRE)
Is NCT04868604 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies multiple treatments including 64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for prostatic neoplasms, castration-resistant.
Treatment: 64Cu-SAR-bisPSMA · 67Cu-SAR-bisPSMA — The aim of this study is to determine the safety and efficacy of 67Cu-SAR-bisPSMA in participants with PSMA-expressing metastatic castrate resistant prostate cancer.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Prostate Cancer
Biomarker criteria
Required: FOLH1 imaging positive (64Cu-SAR-bisPSMA uptake (SUVmax) of at least 1 known lesion is higher than that of the liver)
Positive 64Cu-SAR-bisPSMA PET/CT scan, where 64Cu-SAR-bisPSMA uptake (SUV max) of at least 1 known lesion is higher than that of the liver
Excluded: FOLH1 imaging negative
Evidence of progressive lesion(s) on MRI and/or CT (according to RECIST V1.1) that is prostate-specific membrane antigen (PSMA) negative on the 1 hour 64Cu-SAR-bisPSMA PET/CT scan as determined at screening
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Must have received: androgen receptor pathway inhibitor (enzalutamide, abiraterone, darolutamide, apalutamide) — castration-resistant
progressive metastatic castration-resistant prostate cancer (mCRPC) despite prior androgen deprivation therapy and: Dose Escalation: at least either enzalutamide and/or abiraterone (or other such androgen receptor pathway inhibitors [ARPIs]). Cohort Expansion Main Group: Participant has progressed once or twice on a prior second generation ARPI (abiraterone, enzalutamide, darolutamide, or apalutamide). Cohort Expansion Concomitant Enzalutamide Group: Participant has progressed only once on prior second generation ARPI (prior abiraterone, darolutamide, or apalutamide is allowed, prior treatment with enzalutamide is not allowed).
Cannot have received: systemic radionuclide (177Lu, Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Actinium-225, Iodine-131, Radium-223)
Previous treatment with a systemic radionuclide, including 177Lu, Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Actinium-225, Iodine-131 within 6 months or in case of Radium-223 within 3 months of treatment initiation (Day 0) without prior approval of the medical monitor
Cannot have received: PSMA targeted radionuclide therapy (177Lu, Actinium-225)
Any previous PSMA targeted radionuclide therapy (including 177Lu and Actinium-225) is also excluded
Cannot have received: systemic anti-cancer therapy
Exception: LHRH, any other androgen deprivation therapy (ADT) or low dose corticosteroids allowed
Previous treatment with any systemic anti-cancer therapy (e.g. immunotherapy or biological therapy [including monoclonal antibodies]) within 4 weeks prior to treatment on study with the exception of LHRH, any other androgen deprivation therapy (ADT) or low dose corticosteroids
Cannot have received: chemotherapy
Exception: adjuvant or neoadjuvant taxane exposure (max 6 cycles) allowed if 12 months have elapsed since completion
Prior treatment with cytotoxic chemotherapy for castration resistant PCa (e.g. taxanes, platinum, estramustine, vincristine, methotrexate, etc) is also excluded. Note: Taxane exposure (maximum 6 cycles) in the adjuvant or neoadjuvant setting is allowed if 12 months have elapsed since completion of this adjuvant or neoadjuvant therapy
Cannot have received: PARP inhibitor
Prior treatment with any poly (adenosine diphosphate-ribose) polymerase inhibitors (PARPi) is also excluded
Cannot have received: investigational agent
Previous treatment with any investigational agents within 4 weeks prior enrollment into the study
Lab requirements
Blood counts
WBC ≥2.5 x 10^9/L OR ANC ≥1.5 x 10^9/L; Platelets ≥100 x 10^9/L; Hemoglobin ≥9 g/dL
Kidney function
Creatinine clearance or estimated glomerular filtration rate ≥50 mL/min
Liver function
Total bilirubin ≤1.5 x ULN (≤3 x ULN for Gilbert's Syndrome); ALT or AST ≤3.0 x ULN OR ≤5.0 x ULN for participants with liver metastases
Participants must have adequate organ function: Bone marrow reserve: WBC count ≥2.5 x 10^9/L OR ANC ≥1.5 x 10^9/L; Platelets ≥100 x 10^9/L; Hemoglobin ≥9 g/dL; Total bilirubin ≤1.5 x ULN (≤3 x ULN for Gilbert's Syndrome); ALT or AST ≤3.0 x ULN OR ≤5.0 x ULN for participants with liver metastases; Creatinine clearance or estimated glomerular filtration rate ≥50 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Stanford Cancer Institute · Stanford, California
- East Jefferson General Hospital · River Ridge, Louisiana
- BAMF Health · Grand Rapids, Michigan
- Mayo Clinic · Rochester, Minnesota
- Washington University School of Medicine at Barnes-Jewish Hospital · St Louis, Missouri
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT04868604 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic radionuclide, PSMA targeted radionuclide therapy, systemic anti-cancer therapy disqualifies patients from enrollment.
Does this trial require FOLH1?
Yes, FOLH1 imaging positive is a required biomarker for enrollment.
Are patients with FOLH1 alterations eligible?
No. FOLH1 imaging negative is an exclusion criterion.
Is this trial open to female patients?
No. This trial enrolls male patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages