OncoMatch/Clinical Trials/NCT06084338
Randomized Phase II Trial of Targeted Radiation With no Castration for Mcrpc
Is NCT06084338 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Pluvicto and topical testosterone for prostate cancer.
Treatment: Pluvicto · topical testosterone — This trial tests if the combination of comprehensive metastasis directed therapy delivered by a precision form of external beam radiotherapy (stereotactic ablative radiotherapy), combined with PSMA targeted radiopharmaceutical therapy and cessation of castration, and then followed by testosterone replacement, is an effective treatment for metastatic castration resistant prostate cancer. All patients will be treated with stereotactic ablative radiotherapy and PSMA targeted radiopharmaceutical therapy with cessation of castration. Half of patients are randomized to either receive, or not receive, subsequent testosterone replacement.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Radioligand therapy
Other
Cancer type
Prostate Cancer
Biomarker criteria
Required: FOLH1 psma avidity greater than that of liver
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Must have received: androgen receptor signaling inhibitor (abiraterone acetate, enzalutamide, apalutamide, darolutamide)
Prior use of a novel AR signaling inhibitor for 4 weeks, including abiraterone acetate plus prednisone/prednisolone, enzalutamide, apalutamide, and/or darolutamide
Lab requirements
Blood counts
Hemoglobin (hgb) > 8.0 g/dL; Absolute neutrophil count (ANC) > 1500/ µL; Platelets > 75,000/ µL
Kidney function
Creatinine < (2.0 mg/dL) during screening evaluation (>2.0 is allowed if EGFR >30 mL/min/1.73 m2)
Liver function
Total bilirubin 1.5 x ULN OR direct bilirubin ULN for participants with total bilirubin levels >1.5 x ULN; ALT and AST 3.0 x ULN (5 x ULN for participants with liver metastases) (Child-Pugh class A and B allowed; Child-Pugh class C is excluded)
Adequate organ function: Hemoglobin (hgb) > 8.0 g/dL; Absolute neutrophil count (ANC) > 1500/ µL; Platelets > 75,000/ µL; Total bilirubin 1.5 x ULN OR direct bilirubin ULN for participants with total bilirubin levels >1.5 x ULN; ALT and AST 3.0 x ULN (5 x ULN for participants with liver metastases) (Child-Pugh class A and B allowed; Child-Pugh class C is excluded); Creatinine < (2.0 mg/dL) during screening evaluation (>2.0 is allowed if EGFR >30 mL/min/1.73 m2)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- VA Greater Los Angeles Healthcare System, West Los Angeles, CA · West Los Angeles, California
- Edward Hines Jr. VA Hospital, Hines, IL · Hines, Illinois
- Richard L. Roudebush VA Medical Center, Indianapolis, IN · Indianapolis, Indiana
- VA Ann Arbor Healthcare System, Ann Arbor, MI · Ann Arbor, Michigan
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06084338 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received androgen receptor signaling inhibitor.
Does this trial require FOLH1?
Yes, FOLH1 psma avidity greater than that of liver is a required biomarker for enrollment.
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