A PHASE II TRANSLATIONAL STUDY INVESTIGATING THE BIOLOGICAL EFFECTS OF THE ZOLEDRONIC ACID AS NEOADJUVANT THERAPY ON INVASIVE PROSTATE CANCER - THE JANUS TRIA

• Conditions: invasive prostate cancer; MedDRA version: 12.1Level: LLTClassification code 10036917Term: Prostate cancer stage I

• Registration Number: EUCTR2009-014446-28-IT
• Lead Sponsor: IVERSITA` CAMPUS BIOMEDICO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12-14
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

Men with histological diagnosis of prostate cancer
Stage T1c or T2a disease AND PSA value of 10 ng/ml or less AND a Gleason score of 6 or less
Men older than 75 years OR life expectancy of less than 10 years: PSA can be greater than 10 ng/ml OR the Gleason score can be 7 (3 + 4)
Age ≥ 18 years
WHO performance status 0-2
Written informed consent to all required assessments
Patients must have undergone a core biopsy for the diagnosis of their prostate cancer
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

T0, T1a,b, T2b,c, T3 tumours AND/OR Gleason > 7 AND/OR PSA > 10 if life expectancy > 10 years
Previous hormone or radiotherapy to the treated prostate
Evidence of metastatic disease or recurrent prostate cancer
Previous diagnosis of malignancy unless
onon-melanomatous skin cancer
Serum creatinine > 1.5 x upper limit of normal reference range or calculated creatinine clearance <40 mls/min
Prior treatment with bisphosphonates in the last year
Requiring anticoagulation with warfarin or coumarin derivatives
Known hypersensitivity to bisphosphonates
Current active dental problems including dental abcess or infection of the jawbone (maxilla or mandible) or a current or prior diagnosis of osteonecrosis of the jaw
Recent (within 4 weeks) or planned dental or jaw surgery (recent dental fillings, teeth scaling, polishing or minor gingival surgery do not exclude the patient)
History of bone metabolism diseases
History of active acute and/or chronic inflammatory diseases
Fever (> 37.5 C) in the two weeks before the study enter
Concomitant prolonged treatment with steroids (either IV or oral)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified