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OncoMatch/Clinical Trials/NCT06574880

STereotActic Body Radiotherapy and 177Lutetium PSMA in Locally Advanced Prostate Cancer

Is NCT06574880 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Lu-PSMA-617 for malignant neoplasm of prostate.

Phase 1/2RecruitingAngela Y. Jia, MD PhDNCT06574880Data as of May 2026

Treatment: Lu-PSMA-617The goal of this clinical trial is to is to investigate if it is possible to lower the chance of cancer reoccurrence and also preserve quality of life by using the drug Pluvicto instead of androgen-deprivation therapy to the usual radiation therapy for advanced local prostate cancer. Participants will receive one dose of Pluvicto, followed by radiation about 6 weeks later. Radiation therapy will be completed in 5 treatments over the period of 2 weeks. A second dose of Pluvicto will be given 6 weeks after radiation is complete. Some participants may also receive a third dose of Pluvicto, and this would be given 6 weeks after the second dose of Pluvicto.

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Extracted eligibility criteria

Cancer type

Tumor Agnostic

Prostate Cancer

Biomarker criteria

Required: FOLH1 PSMA avid disease on PSMA PET/CT, tumor in the prostate has SUVmax ≥ 10 (SUVmax ≥ 10)

PSMA avid disease on PSMA PET/CT, where the tumor in the prostate has SUVmax ≥ 10

Disease stage

Required: Stage III

Excluded: Stage M1A ABOVE AORTIC BIFURCATION

Grade: Grade group ≥ 4 (Grade group)

Node positive disease on PSMA PET/CT or conventional imaging...cT3a or cT3b by conventional imaging (MRI) or PSMA PET/CT; Grade group ≥ 4; PSA ≥ 40 ng/mL

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: chemotherapy

Prior treatment for prostate cancer (incudes chemotherapy, radiation therapy, or anti-androgen therapy)

Cannot have received: radiation therapy

Prior treatment for prostate cancer (incudes chemotherapy, radiation therapy, or anti-androgen therapy)

Cannot have received: antiandrogen

Prior treatment for prostate cancer (incudes chemotherapy, radiation therapy, or anti-androgen therapy)

Cannot have received: head and neck radiation therapy

Prior head and neck radiation therapy

Cannot have received: pelvic radiation therapy

History of prior pelvic radiation therapy

Cannot have received: radionuclide therapy (177Lu-PSMA-617)

Prior treatment with radionuclide therapies, 177Lu-PSMA-617 or other

Lab requirements

Blood counts

Hemoglobin > 10 g/dL; WBC > 3000 / mL; ANC ≥ 1,500 / mcL; Platelets ≥ 100,000 / mcL

Kidney function

Creatinine ≤ 1.5x ULN; eGFR > 50 mL/min (CKD-EPI equation); Participants with eGFR 50-60 mL/min require 99mTc-TPA GFR test and only non-obstructive pathology included

Liver function

Total bilirubin < 2× ULN (≤ 2x ULN, except for participants with known Gilbert's Syndrome ≤ 3x ULN is permitted); AST < 3× ULN; Albumin > 3 g/dL

Adequate organ and marrow function to receive treatment: Hemoglobin > 10 g/dL; WBC > 3000 / mL; ANC ≥ 1,500 / mcL; Platelets ≥ 100,000 / mcL; Creatinine ≤ 1.5x ULN; eGFR > 50 mL/min; Total bilirubin < 2× ULN; Albumin > 3 g/dL; AST < 3× ULN

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • University Hospitals Cleveland Medical Center Seidman Cancer Center, Case Comprehensive Cancer Center · Cleveland, Ohio

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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