OncoMatch/Clinical Trials/NCT06520345
The Study of 177Lu-TLX591 Plus SOC Versus SOC Alone in Patients With mCRPC (ProstACT Global)
Is NCT06520345 recruiting? Yes, currently enrolling (Sep 2026). This Phase 3 trial studies multiple treatments including 177Lu-TLX591 and Enzalutamide for metastatic castration-resistant prostate cancer.
Treatment: 177Lu-TLX591 · Enzalutamide · Abiraterone · Docetaxel — The purpose of this study is to evaluate the efficacy and safety of 177Lu-TLX591 in patients with metastatic castration-resistant prostate cancer who have progressed following treatment with Androgen Receptor Pathway Inhibitor Treatment
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Endocrine / hormonal
Radioligand therapy
Cancer type
Prostate Cancer
Biomarker criteria
Required: PSMA (FOLH1) psma expression (tlr ≥2 by 68ga-psma-11 pet/ct or pet/mri) (tlr ≥2)
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Must have received: androgen receptor pathway inhibitor (abiraterone, apalutamide, darolutamide, enzalutamide) — mcspc, nmcrpc, or mcrpc
Cannot have received: monoclonal antibody j591 or huj591 or any other psma targeted therapy
Cannot have received: chemotherapy in the mcrpc or nmcrpc settings
Exception: prior docetaxel use in the mcspc setting with chaarted or stampede regimens is permitted if the last dose of therapy was ≥6 months prior to screening and ≥4 cycles of docetaxel were administered
Cannot have received: concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy
Cannot have received: parp inhibitor (olaparib)
Cannot have received: platinum-based anti-neoplastic drugs
Lab requirements
Blood counts
platelets ≥150×10^9/l; anc ≥1.5×10^9/l; hemoglobin >10g/dl (no transfusion in previous 4 weeks)
Kidney function
creatinine clearance ≥45 ml/min (cockcroft-gault)
Liver function
total bilirubin ≤ 1.5× uln (≤3× uln for gilbert's syndrome); alt or ast ≤3× uln
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Chao Family Comprehensive Cancer Centre · Orange, California
- Biogenix Molecular LLC · Miami, Florida
- United Theranostics · Glen Burnie, Maryland
- XCancer Omaha · Omaha, Nebraska
- Columbia University Herbert Irving Comphrensive Cancer Center · New York, New York
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06520345 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior monoclonal antibody j591 or huj591 or any other psma targeted therapy, chemotherapy in the mcrpc or nmcrpc settings, concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy disqualifies patients from enrollment.
Does this trial require FOLH1?
Yes, FOLH1 psma expression (tlr ≥2 by 68ga-psma-11 pet/ct or pet/mri) 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 qualify