ProsTIC Registry of Men Treated With PSMA Theranostics
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- STATUS
- Recruiting
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- End date
- Dec 31, 2027
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- participants needed
- 200
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- sponsor
- Peter MacCallum Cancer Centre, Australia
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 Identifier | NCT04769817 |
| Sponsor | Peter MacCallum Cancer Centre, Australia |
| Last Modified on | 27 April 2022 |
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