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”.
- Conditions
- prostate cancer with hormone sensitive metastatic bone diseaseMedDRA version: 21.1Level: LLTClassification code 10036927Term: Prostate neoplasiaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2017-000305-21-IT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Male
- Target Recruitment
- 120
1. Histological diagnosis of prostate carcinoma,
2. Age > 18 years,
3. Metastatic disease documented as the presence of bone lesions on bone scan associated or not to soft tissue lesions measurable at CT/RMN,
4. No previous hormone or chemotherapeutic treatments given for prostate carcinoma (patients that are receiving LHRH-A therapy for less than 4 months are admitted),
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 – 1,
6. Expected life expectancy = 6 months,
7. Subject capable to swallow the Study's medication and to comply with the Study's requirements,
8. Signed informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
1. Presence of active serious disease, active infection or co-comorbidity that may prevent the study enrollment make (at the discretion of the clinical Investigator),
2. Known or suspected brain metastases or active leptomeningeal dissemination,
3. History of other malignant neoplasm during the previous 5 years, different from the non-melanoma skin carcinoma,
4. Absolute Neutrophil Count (ANC) < 1.500/µL, platelet < 100.000/µL, or hemoglobin < 5,6 mmol/L (< 9 g/dL) at Screening Visit (notably: patients must not receive neither any growth factor during the previous 7 days nor any blood transfusion during the 28 days preceding the hematology sampling performed at Screening),
5. Total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2,5 x ULN at Screening Visit,
6. Creatinine > 177 µmol/L (> 2 mg/dL) at Screening Visit,
7. Albumin = 30 g/L (= 3,0 g/dL) at Screening Visit,
8. History of seizures or any other seizure-predisposed pathology; history of loss of consciousness or transitory ischaemic attack during the 12 months preceding the Screening visit,
9. Clinically significant cardiovascular disease including:
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main 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 Objective: •Evaluation of bone repair by CT Scan,<br>•Change of bone metabolism's markers,<br>•Changes in bone mineral density and in fat and lean body mass with DEXA scan,<br>•Changes in bone pain (in patients with bone pain at baseline),<br>•SREs evaluation,<br>•Changes in Quality of Life (QoL),<br>•Progression-free survival,<br>•Overall survival.<br>;Primary end point(s): Evaluation of bone response to Enzalutamide treatment with or without Zoledronic Acid in combination with LHRH-A treatment through Whole-body Diffusion MRI.;Timepoint(s) of evaluation of this end point: 2 4 6 9 12 18 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Evaluation of bone repair by CT Scan,<br>•Change of bone metabolism's markers,<br>•Changes in bone mineral density and in fat and lean body mass with DEXA scan,<br>•Changes in bone pain (in patients with bone pain at baseline),<br>•SREs evaluation,<br>•Changes in Quality of Life (QoL),<br>•Progression-free survival,<br>•Overall survival.<br>;Timepoint(s) of evaluation of this end point: 2 4 6 9 12 18 months