Ga-68-PSMA-11 in High-risk Prostate Cancer

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

173

Participants

Timeline

Start Date

October 9, 2017

Primary Completion Date

July 6, 2020

Study Completion Date

July 6, 2020

Conditions
High-risk Prostate CancerProstate CancerProstate Cancer MetastaticLymphnode Metastasis
Interventions
DRUG

Ga-68-PSMA-11

Single administration of 150 MBq (± 50 MBq), corresponding to a mass dose of ≤ 6 µg. A 2nd administration of 150 MBq (± 50 MBq), corresponding to a mass dose of ≤ 6 µg is possible in the unlikely case of a negative histological result (i.e. no prostate-specific membrane antigen (PSMA) expression in dissected lymph nodes) to verify if PSMA PET-positive tissue as seen on day 1 has not been removed during RP with EPLND.

Trial Locations (8)

6020

Medizinische Universität Innsbruck, Innsbruck

45147

Universität Duisburg-Essen, Essen

69120

Universitätsklinikum Heidelberg, Heidelberg

72076

Eberhard-Karls-Universität Tübingen, Tübingen

79106

Albert-Ludwigs-Universität Freiburg, Freiburg im Breisgau

81675

Technische Universität München Klinikum rechts der Isar, München

91054

Friedrich-Alexander-Universität Erlangen, Erlangen

01307

Universitätsklinikum Carl Gustav Carus Dresden, Dresden

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

ABX CRO

OTHER

collaborator

Friedrich-Alexander-Universität Erlangen-Nürnberg

OTHER

collaborator

University Hospital Freiburg

OTHER

lead

German Cancer Research Center

OTHER

NCT03362359 - Ga-68-PSMA-11 in High-risk Prostate Cancer | Biotech Hunter | Biotech Hunter