Prevention of bone metastasis in high risk prostate cancer patients. MedDRA version: 14.1 Level: PT Classification code 10060862 Term: Prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: ZOLEDRONIC ACID
Product Code: CGP42446
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Zoledronic acid
Concentration unit: mg milligram(s)
Concentration n
Sponsors
EAU EUROPEAN ASSOCIATION OF UROLOGY
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: · Male patients aged 18+, ECOG = 0 (Karnofsky performance status > 90). · M0 prostate cancer patients who previously received local curative treatment (e.g. surgery, radiotherapy) or no local curative treatment. Duration between local curative treatment and starting of the study drug must not be longer than 6 months. · At least one of the following conditions must be present: Gleason Score 8-10; - pN+; - PSA ³ 20 at diagnosis. · Patients receiving androgen deprivation by orchiectomy or administration of GnRH analogue ± anti-androgens or no androgen deprivation. Hormone therapy regimen will depend on standard medical management of prostate cancer patients, i.e. when corresponding to standard medical management, patients on hormone treatment at study entry can later be withdrawn and patients not on hormone treatment at study entry can later start with androgen deprivation. Intermittent hormone treatment is allowed when corresponding to standard medical management. Patients should not be under hormonal ablation for longer than 6 months before the first study drug infusion. Neoadjuvant androgen deprivation is allowed as long as the duration between start of androgen deprivation and start of study drug is no longer than 6 months. · Life expectancy of > 6 months · Signed informed consent prior to initiation of any study procedure. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 650 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 650
Exclusion criteria
Exclusion criteria: · Patients with known visceral metastasis or bone metastases in bone scan; · prior treatment with bisphosphonates; · chemotherapy to treat prostate carcinoma; · Anti-androgen monotherapy is not allowed; · use of other investigational drugs (drugs not marketed for any indication) within 6 months before start of study; · history of noncompliance to medical regimens and patients who are considered potentially unreliable or incapable of giving informed consent as judged by the investigator; · Abnormal renal function as evidenced by a calculated creatinine clearance < 30 ml/minute. Creatinine clearance (CrCl) is calculated using the Cockcroft-Gault formula. If serum creatinine is measured in micromol/l, the creatinine value in micromol/l should be multiplied with factor 0.0113 in order to obtain the creatinine value in mg/dL. For example: serum creatinine is 265 micromol/l x 0.0113 = 3 mg/dL. · Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures; · Recent (within 6 weeks) or planned dental or jaw surgery (e.g.. extraction, implants); ·history of other malignant neoplasm within previous five years with exception of nonmelanomatous skin cancer which has been satisfactorily treated; · other known concurrent, severe medical disorder jeopardizing the life of the patient in the immediate future (myocardial infarction in previous six months, angina pectoris despite treatment, uncontrolled severe arterial hypertension, progressive cardiac or respiratory failure)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to show superiority of zoledronic acid as compared to control in the proportion of patients with at least one bone metastasis after 48 months of treatment.;Secondary Objective: · to evaluate the effect of zoledronic acid on the time to the first bone metastasis irrespective whether symptomatic or not; · to evaluate the effect of zoledronic acid on overall survival; · to evaluate the effect of zoledronic acid on serum PSA doubling time; · to evaluate the effect of zoledronic acid on biochemical markers of bone turnover (selected centers only); · to evaluate the effect of zoledronic acid on bone mineral density at two and four years after randomization in patients receiving hormonal therapy at study entry (substudy in selected centers);Primary end point(s): The absolute difference of T-score at the lumbar spine and total hip as evaluated at visit 1 and at visit 10 and visit 18 is the outcome variable for this study.;Timepoint(s) of evaluation of this end point: Not applicable for amendment 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable for amendment 8;Timepoint(s) of evaluation of this end point: Not applicable for amendment 8 | — |
Countries
Italy, Switzerland, Turkey
Contacts
Public ContactClinical Research Associate
Dario Draga`
Outcome results
None listed