WHO ICTRP trial

Phase II trial testing Ablative radiotherapy in metastatic prostate cancer…

EUCTR2016-005284-13-IT · EU Clinical Trials Register · Authorised

Key facts

Trial ID EUCTR2016-005284-13-IT
Public title Phase II trial testing Ablative radiotherapy in metastatic prostate cancer, resistant to hormonal therapy and with number of metastatic lesions lower or equal to three.
Scientific title A 2 arm, phase II controlled randomized trial comparing efficacy and safety of abiraterone and abiraterone associated with Ablative Radiation Therapy in patients with Oligometastatic castration resistant prostate cancer (ARTO trial) - ARTO
Primary sponsor DIPARTIMENTO DI SCIENZE BIOMEDICHE SPERIMENTALI E CLINICHE, UNIVERSITà DI FIRENZE
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): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries Italy
Conditions Oligometastatic prostate cancer, castration resistant MedDRA version: 21.1 Level: PT Classification code 10062904 Term: Hormone-refractory prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl…
Interventions Trade Name: ZYTIGA - 250 MG - COMPRESSA - USO ORALE - FLACONE 120 COMPRESSE Product Name: Zytiga Product Code: [41427016] Pharmaceutical Form: Tablet INN or Proposed INN: abiraterone acetato CAS Number: 154229-18-2 Current Sponsor code…
Registration date Sep 2, 2021
Target size 174
Secondary IDs ARTO
Registry page clinicaltrialsregister.eu

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