EUCTR2009-014446-28-ITActive, not recruitingNot Applicable
A PHASE II TRANSLATIONAL STUDY INVESTIGATING THE BIOLOGICAL EFFECTS OF THE ZOLEDRONIC ACID AS NEOADJUVANT THERAPY ON INVASIVE PROSTATE CANCER - THE JANUS TRIA
IVERSITA` CAMPUS BIOMEDICO0 sitesStarted: December 14, 2009Last updated:
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Male
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)
Investigators
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