Pilot-study: Predicton of response on Lu177-radioligand therapy in metastatic prostate carcinoma by early serial PSA-value examination
Organizational Data
- DRKS-ID:
- DRKS00013500
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2017-12-01
- Last update in DRKS:
- 2019-09-26
- Registration type:
- Retrospective
Acronym/abbreviation of the study
PCA-PSA-EPBR
URL of the study
No Entry
Brief summary in lay language
In late stage, metastatic prostate cancer an "internal radiotherapy" may be applied. This study investigates, whether it is possible to use blood tests on days 1-10 after date of therapy to predict a possible therapy success or not.
Brief summary in scientific language
In late stage, metastatic, castration refractory prostate carcinoma 177Lu-PSMA-617-radioligand therapy can be used as treatment. As biomarker for therapy success or failure PSA-serum values are assessed. This study investigates whether changes of PSA-serum value on days 1-10 after date of therapy may give a prediction to therapy success (evaluated by PSA-serum value 4 weeks after therapy).
Health condition or problem studied
- ICD10:
- C61 - Malignant neoplasm of prostate
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 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.
Endpoints
- Primary outcome:
- Primary outcome is reached by determination of PSA-serum value on date of the control-examination 4 weeks after a therapy cycle
- Secondary outcome:
- /
Study Design
- Purpose:
- Prognosis
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Freiburg im Breisgau
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2017-02-02
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2019-04-11
- Target Sample Size:
- 30
- Final Sample Size:
- 28
Inclusion Criteria
- Sex:
- Male
- Minimum Age:
- no minimum age
- Maximum Age:
- no maximum age
- Additional 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
Addresses
Primary Sponsor
- Address:
- Universitätsklinikum FreiburgHugstetter Strasse 4979095 FreiburgGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uniklinik-freiburg.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Klinik für NuklearmedizinDr. med. Thomas FaßbenderHugstetter Str. 5579106 FreiburgGermany
- Telephone:
- 0761-27039010
- Fax:
- 0761-27073500
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Klinik für NuklearmedizinProf. Dr. med. Juri RufHugstetter Straße 5579106 FreiburgGermany
- Telephone:
- 0761-27039160
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Klinik für NuklearmedizinDr. med. Thomas FaßbenderHugstetter Str. 5579106 FreiburgGermany
- Telephone:
- 0761-27039010
- Fax:
- 0761-27073500
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Universitätsklinikum FreiburgHugstetter Strasse 4979095 FreiburgGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uniklinik-freiburg.de
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Albert-Ludwigs-Universität FreiburgEngelberger Str. 2179106 FreiburgGermany
- Telephone:
- +49-761-27072600
- Fax:
- +49-761-27072630
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2016-10-06
- Ethics committee number:
- 504/16
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2017-01-31
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- Studienprotokoll
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry