hormone refractory metastatic prostate cancer
Conditions
Interventions
Trade Name: Zometa
Pharmaceutical Form: Solvent for solution for infusion
INN or Proposed INN: ZOLEDRONIC ACID
CAS Number: 118072-93-8
Concentration unit: mg milligram(s)
Concentration type: equal
Con
Sponsors
Privatärztliche urologische Partnerschaft GbR, EuromedClinic
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: ?Histologically proven carcinoma of the prostate with evidence of at least one cancer related bone lesion with castration resistant prostate cancer (>2 consecutive rising PSA values determined in an > 2 week interval). ?No changes in antitumoral treatment planned through the course of study. ?Patients with presence of CTCs ?Performance status ECOG 0-2 ?Laboratory requirements: a) hepatic function: total bilirubin = 2,5 times the upper-normal limit of the institution, SGPT, SGOT = 2,5 times the upper-normal limit of the institution. ?Renal function: creatinine clearance ? 30 ml/min ?Life expectancy ? 6 months ?Signed informed consent prior to trial entry ?Prior surgery, chemotherapy and radiotherapy of metastases (including therapeutic radioisotopes such as strontium 89) is allowed. At least 2 months must have elapsed after completion of surgery, chemotherapy and radiotherapy. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: ?Prior treatment with bisphosphonates within 6 months before study start, and during treatment with zoledronic acid ?Prior treatment with antiresorptive agent (e.g. RANK ligand inhibitor) ?Abnormal renal function ?Patients with proven brain metastases ?History of diseases with influence on bone metabolism such as Paget´s disease and primary hyperparathyroidism and with need of treatment for osteoporosis (defined according to DVO, T-Score =2.5). ?Severe physical or psychological concomitant diseases that expected to impair compliance with the provisions of the study protocol or impair the assessment of drug of patient safety (clinically significant ascites, NYHA III or IV, cardiac failure, clinically relevant pathologic findings in ECG) ?Known hypersensitivity to zoledronic acid or other bisphosphonates ?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) ?Known history or present abuse of alcohol or drugs ?Prior malignancy except basal cell or squamous cell skin cancer or any other cancer from which the patient has been disease-free for 5 yrs. ?Use of other investigational drugs at the time of enrollment, or within 30 days before enrollment ?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) ?Any change in therapy within the last 2 months (Chemotherapy, change in hormonal therapy) ?Change of treatment during study duration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Proportion of patients with decreased CTCs at 12 weeks after first infusion of zoledronic acid;Secondary Objective: •Relationship between PSA and course of CTCs •Proportion of patients with stable or decreased CTCs at 12 weeks •Proportion of patients with stable CTCs at 12 weeks •Analysis of patients based on baseline CTCs (Proportion of patients with stable or decreased CTCs at 12 weeks in a subgroup of patients with >5 CTCs at baseline vs proportion of patients with stable or decreased CTCs below 5 CTCs at baseline) •Analysis of patients based on baseline CTCs (Proportion of patients with decreased CTCs at 12 weeks in a subgroup of patients with >5 CTCs at baseline vs proportion of patients with decreased CTCs below 5 CTCs at baseline) •Time until decrease of CTCs •Safety and Tolerability (adverse events (AEs), serious adverse events (SAEs) ;Primary end point(s): Proportion of patients with decreased CTCs at 12 weeks after first infusion of zoledronic acid;Timepoint(s) of evaluation of this end point: 16 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 16 weeks;Secondary end point(s): •Relationship between PSA and course of CTCs •Proportion of patients with stable or decreased CTCs at 12 weeks •Proportion of patients with stable CTCs at 12 weeks •Analysis of patients based on baseline CTCs (Proportion of patients with stable or decreased CTCs at 12 weeks in a subgroup of patients with >5 CTCs at baseline vs proportion of patients with stable or decreased CTCs below 5 CTCs at baseline) •Analysis of patients based on baseline CTCs (Proportion of patients with decreased CTCs at 12 weeks in a subgroup of patients with >5 CTCs at baseline vs proportion of patients with decreased CTCs below 5 CTCs at baseline) •Time until decrease of CTCs •Safety and Tolerability (adverse events (AEs), serious adverse events (SAEs) | — |
Countries
Germany
Contacts
Public ContactStudienzentrum
Überörtliche Gemeinschaftspraxis für Urologie
Outcome results
None listed