prostate cancer C61
Conditions
Interventions
Group 1: standard treatment plus Zometa® 4 mg infusions every 3 months for a total of 48 months
All patients received daily supplements of calcium (500 mg) and vitamin D (400 to 500 IU).
Group 2: sta
Sponsors
European Association of Urology
Eligibility
Sex/Gender
Male
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Eastern Cooperative Oncology Group (ECOG) = 0 (Karnofsky-Index 90) 2. M0 prostate cancer patients who previously received local treatment (e.g. surgery, radiotherapy) or no local treatment. The time frame between local treatment and starting of the study must not be longer than 6 months. 3. At least one of the following conditions must be present: a) Gleason Score 8-10 b) pN+ c) PSA =/ 6 months 5. Signed informed consent prior to initiation of any study procedure.
Exclusion criteria
Exclusion criteria: 1. Patients with known organ metastases or bone metastases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients who develop bone metastases during the study. [Time Frame: until last follow up contact] | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to first bone metastasis; 2. Overall survival [Time Frame: Survival will be assessed until the last patient has finished the follow up period and is defined as time from visit 2 until death.]; 3. Time to PSA doubling; 4. Safety [Safety assessments will consist of regular monitoring and recording of the following parameters: a) Blood biochemistry: serum creatinine (to be evaluated prior to each administration of Zometa® (zoledronic acid)) b) Adverse events / serious adverse events (including new or, compared to baseline, worsened significant findings in physical examination or routine laboratory assessments). c) Laboratory evaluations, Hematology, Blood chemistry (“Complete Biochemistry”), Physical examination; 5. Bone mineral density (sub study in selected centres) [DXA (Dual energy x-ray Absorptiometrie (Visite1 and Visite 18)] and 6. Biochemical markers of bone turnover (sub study in selected centers only). [Skeletal alkaline phosphatase (sALP), Osteoprotegerin, N-terminal propeptide of type I procollagen, C-terminal telopeptide of type I collagen, Cross-linked N-telopeptides of type I collagen (NTx), Tartarte-resistant acid phosphatase 5b (TRAP) (Viste 1 - Visite 18)] | — |
Countries
Belgium, Denmark, Finland, France, Germany, Greece, Italy, Netherlands, Norway, Spain, Sweden, Switzerland, Turkey
Contacts
Public ContactKurt Miller
Universitätsmedizin Berlin - Campus Benjamin Franklin
Outcome results
None listed