ProsTIC Registry of Men Treated With PSMA Theranostics

Last updated: August 29, 2023
Sponsor: Peter MacCallum Cancer Centre, Australia
Overall Status: Active - Recruiting

Phase

N/A

Condition

Urologic Cancer

Prostate Disorders

Prostate Cancer, Early, Recurrent

Treatment

177Lu-PSMA

Clinical Study ID

NCT04769817
PMC 20/164
  • Ages > 18
  • Male

Study 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.

Eligibility Criteria

Inclusion

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

Study Design

Total Participants: 350
Treatment Group(s): 1
Primary Treatment: 177Lu-PSMA
Phase:
Study Start date:
May 01, 2021
Estimated Completion Date:
December 31, 2028

Study 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.

Connect with a study center

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria 3000
    Australia

    Active - Recruiting

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