Effectiveness of Zometa® treatment for the prevention of bone metastases in high risk prostate cancer patients: a randomised, open-label, multicentre 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: Completed

Sex: Male

Target Recruitment: 1300

Inclusion Criteria

1. Male patients aged 18+ years, Eastern Cooperative Oncology Group (ECOG) = 0 (Karnofsky performance status greater than 90)
2. 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.
3. At least one of the following conditions must be present:
3.1. Gleason Score 8 - 10
3.2. pN+
3.3. Prostate specific antigen (PSA) equal to or higher than 20 ng/ml at diagnosis
4. 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i.e. when corresponding to standard medical management, patients on hormone treatment at study entry can later be withdrawn and patients not on hormone treatment at study entry can later start with androgen deprivation.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.
5. Life expectancy of greater than 6 months
6. Signed informed consent prior to initiation of any study procedure

Exclusion Criteria

1. Patients with known visceral metastasis or bone metastases in bone scan
2. Prior treatment with bisphosphonates
3. Chemotherapy to treat prostate carcinoma
4. Anti-androgen monotherapy is not allowed
5. Use of other investigational drugs (drugs not marketed for any indication) within 6 months before start of study
6. History of noncompliance to medical regimens and patients who are considered potentially unreliable or incapable of giving informed consent as judged by the investigator
7. Serum creatinine greater than 3 mg/dl (265 µmol/l)
8. History of other malignant neoplasm within previous five years with exception of non-melanomatous skin cancer which has been satisfactorily treated
9. Other known concurrent, severe medical disorder jeopardising 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

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome parameter is the proportion of patients who develop bone metastases during the study.

Secondary Outcome Measures

Name	Time	Method
1. Time to first bone metastasis<br>2. Overall survival<br>3. Time to PSA doubling<br>4. Safety<br>5. Bone mineral density (sub study in selected centres)<br>6. Biochemical markers of bone turnover (sub study in selected centres only)

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