ProsTIC Registry of Men Treated With PSMA Theranostics

Peter MacCallum Cancer Centre, Australia

Status: Enrolling

Conditions: Metastatic Castration-resistant Prostate Cancer; Prostate Cancer

Treatments: Other: 177Lu-PSMA

Study type: Observational

Funder types: Other

Identifiers

NCT04769817

PMC 20/164

Details and patient eligibility

About

This is a descriptive, observational, prospective, open-ended, registry utilising electronic data capture to collect information on the outcomes of men treated with prostate specific-membrane antigen (PSMA) theranostics.

Full description

The aim of the registry is to collect data of men with pre-treated metastatic castration-resistant prostate cancer (mCRPC) receiving Lutetium 177 (177Lu)-PSMA outside of a clinical trial to assess "real world" anti-tumour utility. The primary objective is to assess prostate specific antigen (PSA) response rate to 177Lu-PSMA in men with mCRPC.

Patients with mCRPC who have have progression or intolerance on a novel anti-androgen targeted agent (abiraterone and/or enzalutamide and/or apalutamide) will be eligible for the study.

The investigators intend to evaluate the safety of 177Lu-PSMA, in addition to determining patient PSA progression-free survival (PFS), objective radiographic response rates and overall survival (OS). Health-related quality of life (QoL) and pain will also be observed. Additional objectives are to identify biomarkers and assess the relationship between PSMA and F-fluorodeoxyglucose (FDG) Positron Emission Tomography-Computed Tomography (PET/CT) parameters associated with clinical outcomes.

Enrollment: 500 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria:

1. Diagnosis of mCRPC
2. Progression or intolerance on a novel anti-androgen therapy (e.g. abiraterone, enzalutamide, apalutamide or darolutamide)
3. Prior therapy with at least one taxane cytotoxic (these agents may have been received upfront for metastatic hormone-sensitive prostate cancer) or the patient is symptomatic and assessed as unfit for chemotherapy
4. Referred to nuclear medicine and being considered for Lu-PSMA therapy according to institutional procedure guidelines