Prostate Cancer Theranostics and Imaging Centre of Excellence (ProsTIC) Prospective Patient Registry of Men Treated With PSMA Theranostics
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- Peter MacCallum Cancer Centre, Australia
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- PSA-RR
- Status
- Recruiting
- Last Updated
- 11 months ago
Overview
Brief 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.
Detailed 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
PSA-RR
Time Frame: From baseline through to progression or death until registry completion (approx. 5 years).
Prostate specific antigen-response rate (PSA-RR) defined as the proportion of participants with a PSA reduction of ≥ 50 percent from baseline.
Secondary Outcomes
- Radiographic progression-free survival (rPFS)(From date of treatment through to progression or death until registry completion (approx. 5 years).)
- PSA progression free survival (PSA-PFS)(From date of treatment through to progression or death until registry completion (approx. 5 years).)
- Number of participants with Adverse Events (AE) and Serious Adverse Events (SAE) measured using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0(From date of treatment to 12 weeks after completing study treatment.)
- Overall survival (OS)(From date of treatment, up until 18 months after the last patient commences treatment.)
- EORTC QLQ-C30(From baseline through to progression or death until registry completion (approx. 5 years).)
- PPI(From baseline through to progression or death until registry completion (approx. 5 years).)