Clinical Trial · NCT05521412

EValuation of radIOLigand Treatment in mEn With Metastatic Castration-resistant Prostate Cancer With [161Tb]Tb-PSMA-I&T

Overview

This clinical trial will evaluate the safety and efficacy of \[161Tb\]Tb -PSMA-I\&T in men with metastatic castration-resistant prostate cancer (mCRPC).

Sponsor

Peter MacCallum Cancer Centre

Phase

Phase 1/2

Contacts

James Butaeu, MD (CONTACT)

james.buteau@petermac.org

(03) 855 96650

ClinicalTrials.gov

NCT05521412

Drug / Compound

PSMA-I&T

Isotope(s):

Target(s):

PSMA

Ligand Class: Small Molecules

Chelator: DOTA

Eligibility

Inclusion

Willing and able to comply with all study requirements, including all treatments and the timing and nature of all required assessments.
Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L
At least 3 weeks since the completion of surgery or radiotherapy prior to registration.
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
Platelets ≥ 150 x 10\^9/L
Patients must have had prior treatment with at least one line of taxane chemotherapy, unless medically unsuitable.
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).
Patients must have adequate bone marrow, hepatic and renal function, defined as:
Patients must have a life expectancy ≥ 6 months.
PSA progression - minimum of 2 rising PSA values from a baseline measurement with an interval of ≥ 1 week between each measurement
Sexually active patients are willing to use medically acceptable forms of barrier contraception.
Soft tissue progression as per Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1) criteria
Prior surgical orchiectomy or chemical castration maintained on luteinizing hormone-releasing hormone (LHRH) analogue (agonist or antagonist).
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
Histologically or cytologically confirmed adenocarcinoma of the prostate, OR unequivocal diagnosis of metastatic prostate cancer (i.e., involving bone or pelvic lymph nodes or para-aortic lymph nodes) with an elevated serum prostate specific antigen (PSA).
Bone progression: ≥ 2 new lesions on bone scan
Patients must have progressive disease defined according to The Prostate Cancer Clinical Trials Working Group 3 (PCWG3) as any one of the following:
Serum testosterone levels ≤ 1.75nmol/L (≤ 50ng/dL).
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
Patients must have had prior treatment with at least one second-generation androgen receptor (AR)-targeted agent (e.g., enzalutamide, abiraterone, apalutamide or darolutamide).
Adequate renal function: patients must have a creatinine clearance estimated of ≥ 40mL/min using the Cockcroft Gault equation (Appendix 3)
Haemoglobin ≥ 100g/L independent of transfusions (no red blood cell transfusion in last 4 weeks)

Exclusion

Patients with symptomatic or impending cord compression unless appropriately treated beforehand and clinically stable for more than 4 weeks.
Site(s) of discordant disease on PET imaging (Fluorodeoxyglucose \[FDG\]-positive and minimal PSMA-uptake).
Symptomatic brain metastases or leptomeningeal metastases.
Other malignancies (in addition to the prostate cancer being treated on this study) within the previous 2-years prior to registration other than basal cell or squamous cell carcinomas of skin or other cancers that are unlikely to recur within 24 months.
Prior treatment with another radioisotope (i.e. PSMA radioligands, radium-223, strontium-89, samarium-153).
Concurrent illness, including severe infection that may jeopardize the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety.