OncoMatch/Clinical Trials/NCT05521412
EValuation of radIOLigand Treatment in mEn With Metastatic Castration-resistant Prostate Cancer With [161Tb]Tb-PSMA-I&T
Is NCT05521412 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies [ 161 Tb]Tb PSMA I&T for prostate cancer.
Treatment: [ 161 Tb]Tb PSMA I&T — This clinical trial will evaluate the safety and efficacy of \[161Tb\]Tb -PSMA-I\&T in men with metastatic castration-resistant prostate cancer (mCRPC).
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Biomarker criteria
Required: FOLH1 significant PSMA avidity (SUVmax ≥ 20 at a site of disease, and SUVmax > 10 at sites of measurable soft tissue disease ≥ 15mm) (SUVmax ≥ 20 at a site of disease, and SUVmax > 10 at sites of measurable soft tissue disease ≥ 15mm)
Significant prostate specific membrane antigen (PSMA) avidity on PSMA positron emission tomography (PET)/computed tomography (CT), defined as a minimum uptake of maximum standardised uptake value (SUVmax) 20 at a site of disease, and SUVmax > 10 at sites of measurable soft tissue disease ≥ 15mm (unless subject to factors explaining a lower uptake, e.g. respiratory motion, reconstruction artefact).
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: taxane
Patients must have had prior treatment with at least one line of taxane chemotherapy, unless medically unsuitable.
Must have received: second-generation androgen receptor-targeted agent (enzalutamide, abiraterone, apalutamide, darolutamide)
Patients must have had prior treatment with at least one second-generation androgen receptor (AR)-targeted agent (e.g., enzalutamide, abiraterone, apalutamide or darolutamide).
Must have received: LHRH agonist or antagonist
Prior surgical orchiectomy or chemical castration maintained on luteinizing hormone-releasing hormone (LHRH) analogue (agonist or antagonist).
Cannot have received: radioisotope (PSMA radioligands, radium-223, strontium-89, samarium-153)
Prior treatment with another radioisotope (i.e. PSMA radioligands, radium-223, strontium-89, samarium-153).
Lab requirements
Blood counts
Haemoglobin ≥ 100g/L independent of transfusions (no red blood cell transfusion in last 4 weeks); ANC ≥ 1.5 x 10^9/L; Platelets ≥ 150 x 10^9/L
Kidney function
Creatinine clearance estimated ≥ 40 mL/min using Cockcroft Gault equation
Liver function
Total bilirubin ≤ 1.5x ULN except for patients with known Gilbert's syndrome (unconjugated bilirubin); AST and ALT ≤ 3x ULN if no liver metastasis or ≤ 5x ULN with liver metastases
Patients must have adequate bone marrow, hepatic and renal function, defined as: Haemoglobin ≥ 100g/L independent of transfusions (no red blood cell transfusion in last 4 weeks); Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L; Platelets ≥ 150 x 10^9/L; Total bilirubin ≤ 1.5x upper limit of normal (ULN) except for patients with known Gilbert's syndrome, where this applies for the unconjugated bilirubin component; Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3x ULN if there is no evidence of liver metastasis or ≤ 5x ULN in the presence of liver metastases; Adequate renal function: patients must have a creatinine clearance estimated of ≥ 40mL/min using the Cockcroft Gault equation
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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