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 (Jun 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
Treatments studied
Other
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)
Demographics
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.
Frequently asked questions
Is NCT05521412 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior radioisotope disqualifies patients from enrollment.
Does this trial require FOLH1?
Yes, FOLH1 significant PSMA avidity (SUVmax ≥ 20 at a site of disease, and SUVmax > 10 at sites of measurable soft tissue disease ≥ 15mm) 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