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

Objectives, structure and design of the Study

Study design

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.

Primary objective

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

Secondary objectives

  • 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.


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.

Clinical phase


Sample size

126 Patients

Number of Centers and location of the Study

X Centers in Italy

Study duration

About 3 years based on the following assumptions:

  1. Recruitment: 12 months
  2. Maximum treatment period: 18 months
  3. Follow-up: 1 months

Study start date

December 2017