OncoMatch/Clinical Trials/NCT06084338
Randomized Phase II Trial of Targeted Radiation With no Castration for Mcrpc
Is NCT06084338 recruiting? Yes, currently enrolling (May 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
Cancer type
Prostate Cancer
Biomarker criteria
Required: FOLH1 PSMA avidity greater than that of liver on 18F-DCFPyL PET (at least one lesion with PSMA avidity greater than that of liver)
PSMA avid metastatic disease as determined by 18F-DCFPyL: at least one lesion with PSMA avidity greater than that of liver
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: androgen receptor signaling inhibitor (abiraterone acetate plus prednisone/prednisolone, enzalutamide, apalutamide, darolutamide) — any (mCSPC, M0CRPC, and/or mCRPC)
Prior use of a novel AR signaling inhibitor for 4 weeks, including abiraterone acetate plus prednisone/prednisolone, enzalutamide, apalutamide, and/or darolutamide
Cannot have received: anti-neoplastic therapies for prostate cancer
Exception: must be completed > 2 weeks prior to Day 1 (initiation of first dose of PSMA RLT); investigational agents > 4 weeks prior
Anti-neoplastic therapies for prostate cancer must be completed > 2 weeks prior to Day 1 (initiation of first dose of PSMA RLT); Investigational agents must have been completed > 4 weeks of Day 1
Cannot have received: radiotherapy
Exception: must be completed > 2 weeks prior to start of study treatment; must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis
Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis
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 →
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