ProsTIC Registry of Men Treated With PSMA Theranostics
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Metastatic Castration Resistant Prostate Cancer
- Prostate Cancer
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
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) re...
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.
Tracking Information
- NCT #
- NCT04769817
- Collaborators
- Not Provided
- Investigators
- Not Provided