OncoMatch/Clinical Trials/NCT05079698
A Study of Stereotactic Body Radiotherapy and 177Lu-PSMA-617 for the Treatment of Prostate Cancer
Is NCT05079698 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies 177Lu-PSMA-617 for prostate cancer.
Treatment: 177Lu-PSMA-617 — The researchers are doing this study to find out whether giving 177Lu-PSMA-617 followed by a type of radiation therapy called SBRT (stereotactic body radiation therapy) is a safe treatment for your cancer. The study agent has been shown to target tumor cells, and the researchers think that adding 177Lu-PSMA-617 to SBRT may prevent or delay the cancer from continuing to spread.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Biomarker criteria
Required: FOLH1 imaging positive
Patient must have had a PSMA scan within 2 months of enrollment on study; Patient must have 1-5 oligometastatic tumors or lesions of the bone or soft tissue that are detectable on a PSMA PET scan
Excluded: FOLH1 imaging negative
Patients with PSMA negative metastatic lesions or with a mixture of PSMA avid and PSMA negative disease
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: surgery and/or definitive radiation — primary tumor
The patient's primary tumor must have been previously treated with surgery and/or definitive radiation. Prior salvage treatments (radiation or surgery) to the prostate bed or pelvis is allowed.
Cannot have received: prostate-cancer directed therapy
Exception: since undergoing screening PSMA scan
Patient has not received any form of prostate-cancer directed therapy since undergoing screening PSMA scan
Cannot have received: radiotherapy to > 25% of the skeleton
Patients with prior radiotherapy to > 25% of the skeleton
Cannot have received: 223Radium, 89Strontium or 153Samarium containing compounds (223Radium, 89Strontium, 153Samarium)
prior exposure to prior 223Radium, 89Strontium or 153Samarium containing compounds
Lab requirements
Blood counts
Total white blood count > 3.0 K/mcL; Absolute Neutrophil Count ≥ 1.5 K/mcL; Platelets ≥ 100 K/mcL; Hemoglobin ≥ 9 g/dL
Kidney function
serum creatinine level < 1.5 x ULN or EGFR > 60 mL/min
Liver function
ALT and AST ≤ 2.5 x ULN; Albumin > 2 g/dL; Bilirubin < 3 X ULN
Patient must have a serum creatinine level < 1.5 x ULN or EGFR > 60 mL/min; ALT and AST ≤ 2.5 x ULN; Albumin > 2 g/dL; Bilirubin < 3 X ULN; Total white blood count > 3.0 K/mcL; Absolute Neutrophil Count ≥ 1.5 K/mcL; Platelets ≥ 100 K/mcL; Hemoglobin ≥ 9 g/dL
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) · Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) · Middletown, New Jersey
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) · Montvale, New Jersey
- Memorial Sloan Kettering Commack (Limited Protocol Activities) · Commack, New York
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) · Harrison, New York
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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