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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00013500 |
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Date of registration:
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01/12/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Pilot-study: Predicton of response on Lu177-radioligand therapy in metastatic prostate carcinoma by early serial PSA-value examination
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Scientific title:
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Pilot-study: Predicton of response on Lu177-radioligand therapy in metastatic prostate carcinoma by early serial PSA-value examination - PCA-PSA-EPBR |
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Date of first enrolment:
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02/02/2017 |
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Target sample size:
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30 |
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Recruitment status: |
Complete |
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URL:
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http://drks.de/search/en/trial/DRKS00013500 |
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Study type:
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observational |
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Study design:
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Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: Prognosis
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Phase:
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Countries of recruitment
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Germany
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Contacts
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Name:
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Thomas
Faßbender |
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Address:
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Hugstetter Str. 55
79106
Freiburg
Germany |
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Telephone:
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0761-27039010 |
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Email:
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thomas.fassbender@uniklinik-freiburg.de |
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Affiliation:
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Klinik für Nuklearmedizin |
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Name:
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Juri
Ruf |
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Address:
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Hugstetter Straße 55
79106
Freiburg
Germany |
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Telephone:
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0761-27039160 |
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Email:
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juri.ruf@unklinik-freiburg.de |
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Affiliation:
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Klinik für Nuklearmedizin |
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Key inclusion & exclusion criteria
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Inclusion criteria: Metastatic, castration refractory prostate carcinoma,
Lu177-PSMA-617-radioligand therapy planned
Exclusion criteria: No significant PSA-serum level = supposingly no PSA expression of tumor
Age minimum:
None
Age maximum:
None
Gender:
Male
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Health Condition(s) or Problem(s) studied
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C61
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Malignant neoplasm of prostate
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Intervention(s)
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Group 1: On date of therapy and 1, 2, 3, 8 days after therapy PSA-serum values are determined and compared with the PSA-value 4 weeks after therapy.
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Primary Outcome(s)
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Primary outcome is reached by determination of PSA-serum value on date of the control-examination 4 weeks after a therapy cycle
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Source(s) of Monetary Support
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Universitätsklinikum Freiburg
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Ethics review
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Status: Approved
Approval date: 31/01/2017
Contact:
ekfr.mpg@uniklinik-freiburg.de
Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
+49-761-27072600
ekfr.mpg@uniklinik-freiburg.de
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