OncoMatch/Clinical Trials/NCT05893381
Lu-PSMA and Stereotactic Radiotherapy Versus Radiotherapy Alone for Prostate Cancer (LUST)
Is NCT05893381 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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)
Demographics
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.
Frequently asked questions
Is NCT05893381 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior androgen deprivation therapy, chemotherapy or radiotherapy, radiation therapy disqualifies patients from enrollment.
Does this trial require FOLH1?
Yes, FOLH1 PSMA-PET/CT positive scan matching with lesions documented on baseline CT/MRI or WBD-MRI is a required biomarker for enrollment.
Does this trial require KLK3?
Yes, KLK3 PSA ≥ 0.2 ng/mL but ≤ 50 ng/mL is a required biomarker for enrollment.
Does this trial require KLK3?
Yes, KLK3 PSA doubling time (PSADT) < 15 months 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