Effectiveness of Zometa® treatment for the prevention of bone metastases in high risk prostate cancer patients

• Register: German Clinical Trials Register
• Last refreshed on: 8 April 2024
• Main ID: DRKS00004981
• Date of registration: 23/06/2014
• Prospective Registration: No
• Primary sponsor: European Association of Urology
• Public title: Effectiveness of Zometa® treatment for the prevention of bone metastases in high risk prostate cancer patients
• Scientific title: Effectiveness of Zometa® treatment for the prevention of bone metastases in high risk prostate cancer patients - ZEUS
• Date of first enrolment: 14/10/2004
• Target sample size: 1300
• Recruitment status: Complete
• URL: http://drks.de/search/en/trial/DRKS00004981
• Study type: interventional
• Study design: Allocation: Randomized controlled study; Masking: Open (masking not used); Control: active; Assignment: parallel; Study design purpose: prevention
• Phase: 3

Countries of recruitment

Belgium, Denmark, Finland, France, Germany, Greece, Italy, Netherlands, Norway, Spain, Sweden, Switzerland, Turkey

Contacts

• Name: Kurt Miller
• Affiliation: Universitätsmedizin Berlin - Campus Benjamin Franklin

• Name: Kurt Miller
• Affiliation: Universitätsmedizin Berlin - Campus Benjamin Franklin

Key inclusion & exclusion 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 =/< 20 at first diagnosis
4. Life expectancy of > 6 months
5. Signed informed consent prior to initiation of any study procedure.


Exclusion criteria: 1. Patients with known organ metastases or bone metastases

Age minimum: 18 Years
Age maximum: 99 Years
Gender: Male

Health Condition(s) or Problem(s) studied

prostate cancer
C61

Malignant neoplasm of prostate

Intervention(s)

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: standard treatment only (i.e., standard androgen deprivation therapy)

All patients received daily supplements of calcium (500 mg) and vitamin D (400 to 500 IU).

Primary Outcome(s)

The proportion of patients who develop bone metastases during the study. [Time Frame: until last follow up contact]

Secondary Outcome(s)

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)]

Source(s) of Monetary Support

Novartis Pharma GmbH

Ethics review

Status: Approved
Approval date: 13/04/2004
Contact:

[e-mail]

Ethikkommission der Charité – Universitätsmedizin Berlin

([phone]

[e-mail]

Results

• Date Completed: 31/12/2011
• URL: http://drks.de/search/en/trial/DRKS00004981#studyResults