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 (Jun 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: FOLH1 PSMA-positive by imaging (TLR ≥2 on 68Ga-PSMA-11 PET/CT or PET/MRI) (TLR ≥2)
disease that is PSMA-positive, as demonstrated by a 68Ga-PSMA-11 PET/CT or PET/MRI scan and confirmed as eligible by the Sponsor's appointed BICR. PSMA positivity is defined as : At least 1 lesion with PSMA TLR≥2.
Excluded: FOLH1 PSMA-negative lesion (visceral, lytic bone, or lymph node) with TLR <1
PSMA exclusion criteria: i) visceral metastatic lesions that are ≥1 cm that have a PSMA TLR< 1 ii) Lytic bone metastatic lesions with a soft tissue component of at least 1 cm with a TLF <1. iii) At least one metastatic lymph node lesion with short axis ≥2.5 cm with a TLF<1.
Disease stage
Required: Stage IV
Metastatic disease required
Have metastatic disease (defined as ≥1 metastatic lesion present on baseline CT, MRI or bone scintigraphy)
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 first-line mCRPC
Must have received a minimum of 12 weeks of prior therapy on their first ARPI (abiraterone, apalutamide, darolutamide or enzalutamide), received in either mCSPC (de novo or recurrent) nmCRPC or first-line mCRPC treatment setting with documented evidence of disease progression while receiving this ARPI.
Cannot have received: PSMA targeted therapy (J591, HuJ591)
Has received prior treatment with monoclonal antibody (mAb) J591 or HuJ591 or any other PSMA targeted therapy.
Cannot have received: chemotherapy
Exception: Prior docetaxel use in the mCSPC setting with CHAATERED or STAMPEDE regimens is permitted if the last dose of therapy was ≥6 months prior to screening and ≥4 cycles of docetaxel were administered.
Have received chemotherapy in the mCRPC or non-metastatic prostate cancer (nmCRPC) settings (note: prior docetaxel use in the mCSPC setting with CHAATERED 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: PARP inhibitor (olaparib)
Has received treatment with any PARP inhibitors (i.e., Olaparib)
Cannot have received: platinum-based chemotherapy
Has received treatment with any...platinum based anti-neoplastic drugs.
Cannot have received: radioisotope (89Strontium, 153Samarium, 186Rhenium, 188Rhenium, 223Radium)
Has received prior treatment with radioisotopes, including but not limited to: 89Strontium, 153Samarium, 186Rhenium, 188Rhenium, 223Radium, or hemi-body irradiation within 6 months prior to enrolment.
Lab requirements
Blood counts
Platelets ≥150×10^9/L; Absolute neutrophil count ≥1.5 x 10^9/L; Hemoglobin >10g/dL (no RBC transfusion in previous 4 weeks)
Kidney function
Creatinine clearance ≥45 mL/min determined using the Cockcroft-Gault formula
Liver function
Total bilirubin ≤ 1.5× ULN (≤3× ULN if Gilbert's Syndrome); ALT or AST ≤3× ULN
Have adequate organ function at Screening: Bone marrow: Platelets ≥150×10^9/L. Absolute neutrophil count ≥1.5 x 10^9/L. Hemoglobin >10g/dL (with no red blood cell transfusion in the previous 4 weeks). Liver function: Total bilirubin ≤ 1.5× the upper limit of normal (ULN). For participants with known Gilbert's Syndrome ≤3× ULN is permitted. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤3× ULN. Renal function: Creatinine clearance ≥45 mL/min determined using the Cockcroft-Gault formula.
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 PSMA targeted therapy, chemotherapy, PARP inhibitor disqualifies patients from enrollment.
Does this trial require FOLH1?
Yes, FOLH1 PSMA-positive by imaging (TLR ≥2 on 68Ga-PSMA-11 PET/CT or PET/MRI) is a required biomarker for enrollment.
Are patients with FOLH1 alterations eligible?
No. FOLH1 PSMA-negative lesion (visceral, lytic bone, or lymph node) with TLR <1 is an exclusion criterion.
What disease stage is eligible?
Stage IV is required (metastatic disease required).
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