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| ID | Type | Description | Link |
|---|---|---|---|
| NL84672.078.23 | Other Identifier | CCMO |
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This prospective study aims to collect data and blood biomarkers from patients undergoing Lu-PSMA therapy at the Erasmus MC. In doing so, it will provide real-world efficacy and safety data on the drug, gather dosimetry data and explore putative biomarkers to identify patients who most benefit from Lu-PSMA treatment.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood draw for ctDNA and circulating tumor cell collection. | Diagnostic Test | During routine blood sample collection, additional blood will be drawn for analysis of ctDNA and to collect Circulating Tumor Cells. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Overall survival will be defined as the time from inclusion to death from any cause. | 44 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | Progression free survival will be defined as clinical, radiological or PSA progression according to Prostate Cancer Working Group 3 (PCWG3) or death, whichever occurs first. | 44 months |
| Heterogeneity of PSMA-positivity |
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Inclusion Criteria:
Exclusion Criteria:
None applicable
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Patients diagnosed with metastatic castration resistant prostate cancer set to receive treatment with Lutetium-177 Prostate Specific Membrane Antigen (Lu-PSMA) as a part of regular clinical care.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stijn Koolen, PhD | Contact | +31638740656 | s.koolen@erasmusmc.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus MC | Recruiting | Rotterdam | South Holland | 3015 CN | Netherlands |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Circulating tumor DNA is obtained as part of this study to explore PSMA expression and how this relates to therapy outcomes. Plasma samples are stored according to standard of conservation.
Exploring heterogeneity of PSMA-positivity in circulating tumor cells (CTC) prior to treatment with Lutetium-PSMA.
| 44 months |
| Effect of CTC PSMA expression on response to treatment. | Exploring whether there is an association between the fraction of PSMA positive CTCs and response to Lutetium-PSMA treatment. | 44 months |
| Effect of biomarkers in blood on response to treatment. | Exploring the association between biomarkers in blood and response to treatment | 44 months |
| PSMA-PET scan data and response to treatment. | Exploring associations between PSMA-PET and therapy scans and response to treatment. | 44 months |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |