The Study of 177Lu-TLX591 Plus SOC Versus SOC Alone in Patients With mCRPC (ProstACT Global)

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.

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.