WHO ICTRP trial

Phase III clinical trial Oligometastatic and Oligorecurrent PROstate Cancer…

EUCTR2018-004458-14-IT · EU Clinical Trials Register · Authorised

Key facts

Trial ID EUCTR2018-004458-14-IT
Public title Phase III clinical trial Oligometastatic and Oligorecurrent PROstate Cancer: enhancing patients’ selection by new ImagiNG biomarkers
Scientific title Phase III clinical trial Oligometastatic and Oligorecurrent PROstate Cancer: enhancing patients’ selection by new ImagiNG biomarkers - PROvING
Primary sponsor AZIENDA OSPEDALIERO-UNIVERSITARIA PISANA
Registry EU Clinical Trials Register
Recruitment status Authorised
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries Italy
Conditions Prostate cancer MedDRA version: 21.0 Level: PT Classification code 10036911 Term: Prostate cancer recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: LLT…
Interventions Product Name: 68Ga-complex of Glu-NH-CO-NH-Lys-(Ahx)-HBED-CC Product Code: [68GaPSMA-11] Pharmaceutical Form: Solution for injection INN or Proposed INN: 68Ga-complex of Glu-NH-CO-NH-Lys-(Ahx)-HBED-CC Current Sponsor code: [68Ga]PSMA-11…
Registration date Oct 21, 2020
Target size 246
Secondary IDs PROvING
Registry page clinicaltrialsregister.eu

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