BonEnza

Assessment of bone response after LHRH-A and Enzalutamide plus minus Zoledronic Acid in prostate cancer patients with hormone sensitive metastatic bone disease: a prospectic, phase II, randomized, multicenter study

Obiettivi, struttura e articolazione dello Studio

Disegno dello Studio

This is a multicenter prospective randomized clinical trial aiming to test the activity of LHRH-A plus enzalutamide plus/minus Zoledronic Acid in terms of bone response assessed by Whole body diffusion MRI in prostate cancer patients with bone metastatic hormone naive disease.

Scopo primario

Evaluation of bone response to Enzalutamide treatment with or without Zoledronic Acid in combination with LHRH-A treatment through Whole-body Diffusion MRI.

Obiettivi secondari

  • Evaluation of bone repair by CT Scan.
  • Change of bone metabolism's markers.
  • Changes in bone mineral density and in fat and lean body mass with DEXA scan.
  • Changes in bone pain (in patients with bone pain at baseline).
  • SREs evaluation.
  • Changes in Quality of Life (QoL).
  • Progression-free survival.
  • Overall survival.

Trattamento

Prostate cancer patients with hormone sensitive metastatic bone disease will be randomized 1:1 in the following treatment groups:

  • LHRH-A + Enzalutamide
  • LHRH-A + Enzalutamide + Zoledronic Acid

The treatment will prosecute until patient's progression, consent withdrawal or unaccettable toxicity.

Fase clinica

II

Dimensione del campione

126 Pazienti

Numero di Centri e localizzazione dello Studio

X Centri in Italia

Durata dello Studio

About 3 years sulla base delle seguenti assunzioni:

  1. Reclutamento: 12 mesi
  2. Massimo periodo di trattamento: 18 mesi
  3. Follow up: 1 mesi

Data di inizio dello Studio

December 2017