ProsTIC Registry of Men Treated With PSMA Theranostics

  • STATUS
    Recruiting
  • End date
    Dec 31, 2027
  • participants needed
    200
  • sponsor
    Peter MacCallum Cancer Centre, Australia
Updated on 27 April 2022

Summary

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.

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.

Details
Condition Prostate Cancer, Metastatic Castration-resistant Prostate Cancer
Treatment 177Lu-PSMA
Clinical Study IdentifierNCT04769817
SponsorPeter MacCallum Cancer Centre, Australia
Last Modified on27 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis of mCRPC
Progression or intolerance on a novel anti-androgen therapy (e.g. abiraterone, enzalutamide, apalutamide or darolutamide)
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
Referred to nuclear medicine and being considered for Lu-PSMA therapy according to institutional procedure guidelines
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