The objective of this study is to collect data on treatment outcomes when treating mCRPC using Lu-PSMA. In addition to this, the study aims to identify correlations between biomarkers (ctDNA and CTC*s) and dosimetry data with treatment outcomes of…
ID
Source
Brief title
Condition
- Reproductive neoplasms male malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The present study is observational in nature. The study tracks overall survival
as endpoint to assess the efficacy of treatment.
Secondary outcome
Progression free survival on the basis of clinical data, radiological imaging
as well as PSA.
Heterogeneity of PSMA-positivity in circulating tumor cells (CTC) prior to
treatment with Lutetium-PSMA.
Association between ctDNA in blood and other biomarkers with treatment outcomes
of Lutetium-PSMA treatment.
Association between PSMA-PET and therapy scans with treatment outcomes of
Lutetium-PSMA treatment.
Background summary
Radioligand therapy (RLT) using Lutetium-177 Prostate Specific Membrane Antigen
(Lu-PSMA) is a treatment option for metastatic castration resistant prostate
cancer (mCRPC) that was introduced in clinical practice at the Erasmus MC in
2022. Previous research has shown clear advantages of applying this therapy on
patient overall and progression-free survival. However, experience with this
therapy is still limited. Documentation of adverse events and treatment
outcomes in clinical practice could provide valuable information for future
research. In addition, there is limited insight into biomarkers that are
associated with Lu-PSMA treatment outcomes. This data could help future studies
determine which patients benefit most from Lu-PSMA therapy and how it can be
used most effectively.
Study objective
The objective of this study is to collect data on treatment outcomes when
treating mCRPC using Lu-PSMA. In addition to this, the study aims to identify
correlations between biomarkers (ctDNA and CTC*s) and dosimetry data with
treatment outcomes of Lu-PSMA.
Study design
The presented study uses a prospective observational study design. Data will be
collected from electronic health records (EHR) and through a series of blood
draws taken before, and during treatment.
Study burden and risks
None
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
- Participants should be at least 18 years old.
- Participants should be able to understand the written information and be able
to provide informed consent.
- Participants are planned to start treatment with Lu-PSMA as a part of regular
clinical care.
Exclusion criteria
None Applicable
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL84672.078.23 |