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&…
ID
Source
Brief title
Condition
- Reproductive neoplasms male malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
- Other intervention
N.a.
Outcome measures
Primary outcome
<p>The present study is observational in nature. The study tracks overall survival<br />
as endpoint to assess the efficacy of treatment.</p>
Secondary outcome
<p>Progression free survival on the basis of clinical data, radiological imaging<br>as well as PSA.<br>Heterogeneity of PSMA-positivity in circulating tumor cells (CTC) prior to<br>treatment with Lutetium-PSMA.<br>Association between ctDNA in blood and other biomarkers with treatment outcomes<br>of Lutetium-PSMA treatment.<br>Association between PSMA-PET and therapy scans with treatment outcomes of<br>Lutetium-PSMA treatment.<br>Validation of the use of dried blood spots to measure blood concentration of Lu-177 during use of Lu-PSMA.</p>
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.
In the DBS sub-study, the objective is to validate DBS sampling as a reliable alternative to traditional venous blood sampling for measuring Lutetium-177 concentrations. By comparing DBS-derived and venous-derived dosimetry data, this study aims to assess the accuracy, precision, and clinical utility of DBS in dosimetry. If DBS sampling is found to be accurate. DBS samples will also be used for dosimetry purposes in this study.
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.
Patients who opt to participate in the DBS sub-study will provide DBS samples once daily for five days following administration of Lu-PSMA. Initial DBS samples will be collected alongside venous blood draws, allowing for direct comparison between the two methods to validate DBS as a collection method used for dosimetry.
Intervention
This study aims to collect data about the use of Lu-PSMA. The treatments that patients receive are part of regular clinical care and not affected by participation in the study.
Study burden and risks
None
K.R. Doornhof
Dr. Molewaterplein 40
Rotterdam 3015 GD
Netherlands
+31631016293
k.doornhof@erasmusmc.nl
K.R. Doornhof
Dr. Molewaterplein 40
Rotterdam 3015 GD
Netherlands
+31631016293
k.doornhof@erasmusmc.nl
Trial sites in the Netherlands
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
Medical products/devices used
IPD sharing statement
Plan description
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 |
|---|---|
| ClinicalTrials.gov | NCT06260410 |
| CCMO | NL84672.078.23 |
| Research portal | NL-007131 |