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A Phase II Study Evaluating the Efficacy of Enzalutamide and the Role of ARv7 in Metastatic Castration Resistant Prostate Cancer (mCRPC) Patients With Visceral Disease.

NCT03103724 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2021-04-26

No results posted yet for this study

Summary

Open label, single arm, phase II multicentre study designed to determine the clinical benefit, as measured by 3-months disease control rate (DCR) provided by enzalutamide in metastatic Castration Resistant Prostate Cancer patients with at least one visceral site involvement.

Conditions

  • Carcinoma Prostate

Interventions

DRUG

Xtandi

Enzalutamide 160 mg (4 x 40 mg capsules), orally once daily

Sponsors & Collaborators

  • Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

    lead OTHER

Principal Investigators

  • Elena Verzoni, MD · Fondazione IRCCS Istituto Nazionale Tumori Milano

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-16
Primary Completion
2021-04-23
Completion
2021-04-23

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03103724 on ClinicalTrials.gov