OncoMatch/Clinical Trials/NCT05893381
Lu-PSMA and Stereotactic Radiotherapy Versus Radiotherapy Alone for Prostate Cancer (LUST)
Is NCT05893381 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies [177Lu]Lu-PSMA I&T for prostate cancer.
Treatment: [177Lu]Lu-PSMA I&T — Multicenter, open-label, parallel-group, phase II randomized study in patients with oligometastatic prostate cancer with 1-3 asymptomatic metastases of the soft tissue or bone. Eligible patients will be randomized at 1:1 ratio to Stereotactic Radiotherapy followed by Lu-PSMA (arm A) or Stereotactic Radiotherapy (arm B)
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Biomarker criteria
Required: FOLH1 PSMA-PET/CT positive scan matching with lesions documented on baseline CT/MRI or WBD-MRI (SUV max ≥ 3)
PSMA-PET/CT positive scan matching with lesions documented on baseline CT/MRI or WBD-MRI. Diagnostic PET/CT PSMA SUV max is ≥ 3.
Required: KLK3 PSA ≥ 0.2 ng/mL but ≤ 50 ng/mL (≥ 0.2 ng/mL and ≤ 50 ng/mL)
Prostate specific antigen (PSA) ≥ 0.2 ng/mL but ≤ 50 ng/mL
Required: KLK3 PSA doubling time (PSADT) < 15 months (< 15 months)
PSA doubling time (PSADT) < 15 months
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: surgery — primary tumor
Patients must have had their primary tumor treated with surgery and/or radiation
Must have received: radiation therapy — primary tumor
Patients must have had their primary tumor treated with surgery and/or radiation
Cannot have received: androgen deprivation therapy
Exception: No more than 3 years of ADT is allowed, with the most recent ADT treatment having occurred more than 6 months prior to enrollment.
No more than 3 years of ADT is allowed, with the most recent ADT treatment having occurred more than 6 months prior to enrollment.
Cannot have received: chemotherapy or radiotherapy (nitrosoureas, mitomycin C)
Exception: chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. A window of 3 days is permitted.
Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. A window of 3 days is permitted.
Cannot have received: radiation therapy
Previous radiation therapy on the metastatic site
Lab requirements
Blood counts
Leukocytes >2,000/μL; Absolute neutrophil count >1,000/μL; Platelets >75,000/μL
Kidney function
Creatinine within normal institutional limits
Liver function
total bilirubin within normal institutional limits (except Gilbert's syndrome); AST(SGOT)/ALT(SGPT) ≤ 2.5 X institutional upper limit of normal
Patients must have normal organ and marrow function as defined as: Leukocytes >2,000/μL; Absolute neutrophil count >1,000/μL; Platelets >75,000/μL; total bilirubin within normal institutional limits (this will not apply to patients with confirmed Gilbert's syndrome); AST(SGOT)/ALT(SGPT) ≤ 2.5 X institutional upper limit of normal; Creatinine within normal institutional limits.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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