Effectiveness of Zometa treatment for the prevention of bone metastases in high risk prostate cancer patients. A randomized, open-label, multicenter study of the European Association of Urology (EAU) in Cooperation with the Scandinavian Prostate Cancer Group (SPCG) and the Arbeitsgemeinschaft Urologische Onkologie (AUO)

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 1300

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i.e. when corresponding to standard medical management, patients on hormone treatment at study entry can later be withdrawn and patients not on hormone treatment at study entry can later start with androgen deprivation.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

· 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)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials