Prostate Cancer
Conditions
Keywords
Serum bone marker, Prostate cancer, Bisphosphonates, Early detection of metastasis
Brief summary
It is the aim of this prospective, single-group, clinical study to assess whether bone parameters can be used as diagnostic tools for early detection of bone metastases in patients with high risk prostate cancer. The usefulness in monitoring zoledronic acid therapy in patients who have developed bone metastases will also be assessed.
Interventions
DRUGZoledronic acid
In case of bone metastases: Zoledronic acid every 4 weeks for 3 months.
Sponsors
Novartis
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with histologically confirmed diagnosis of prostate cancer who have not yet developed bone metastases * Prostate cancer patients with a rise in PSA under hormone therapy. PSA criteria: * Patients who have undergone prostatectomy: any rise in PSA or * Patients without prostatectomy: 2 consecutive rises in PSA levels relative to a previous reference value, separated by one month. The first measurement must occur one month after the reference value and must be above the reference value. The second confirmatory measurement taken one month after the first measurement must be greater than the first measurement. * Previous chemotherapy or radiotherapy must have been performed ≥ 8 weeks prior to study entry. * Eastern Cooperative Oncology Group (ECOG) score of 0, 1 or 2 (patients that spend less than 50% of time in bed during the day) * Adequate liver function - serum total bilirubin concentration less than 1.5 x upper limit of normal value * Age: ≥ 18 years * Patient has given written informed consent prior to any study-specific procedures. Patients with psychiatric or addictive disorders which prevent them from giving their informed consent must not enter the study.
Exclusion criteria
* Prior treatment with a bisphosphonate * Abnormal renal function as evidenced by a calculated creatinine clearance \< 30 ml/minute. * Corrected (adjusted for serum albumin) serum calcium concentration \< 8.0 mg/dl (2.00 mmol/L) or ≥ 12.0 mg/dl (3.00 mmol/L). * Patients with clinically symptomatic brain metastases * History of diseases with influence on bone metabolism such as Paget's disease and primary hyperparathyroidism * Severe physical or psychological concomitant diseases that might impair compliance with the provisions of the study protocol or that might impair the assessment of drug or patient safety, e.g. clinically significant ascites, cardiac failure, NYHA III or IV, clinically relevant pathologic findings in ECG * Known hypersensitivity to zoledronic acid or other bisphosphonates * Use of other investigational drugs 30 days prior to the date of randomization * Known history or present abuse of alcohol or drugs * Subjects who, in the opinion of the investigator, are unlikely to cooperate fully during the study * 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) Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • To assess the relationship between change in bone parameters and bone scan with respect to bone metastases | Every 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of course of Prostate-specific antigen (PSA) | Every 3 months |
| Assessment of correlation of bone parameters and PSA | Every 3 months |
| Assessment of course of bone parameters (PINP, amino-terminal propeptide of procollagen type 1) and (ICTP, Pyridinoline cross-linked carboxyterminal telopeptide of type I collagen) | Every 3 months |
| Assessment of time to rise in bone markers PINP and ICTP | Every 3 months |
| • Time to detection of bone metastases in bone scan | Every 3 months |
| Assessment of optimal intervals for bone scans based on serum markers | Every 3 months |
Countries
Germany
Outcome results
None listed