Evaluation of Bone Markers as Diagnostic Tools for Early Detection of Bone Metastases in Patients With High Risk Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00391690
First received: October 23, 2006
Last updated: October 11, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: Zoledronic acid
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Bone Markers as Diagnostic Tools for Early Detection of Bone Metastases in Patients With High Risk Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • • To assess the relationship between change in bone parameters and bone scan with respect to bone metastases [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]
  • Assessment of course of Prostate-specific antigen (PSA) [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]
  • Assessment of correlation of bone parameters and PSA [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]
  • Assessment of optimal intervals for bone scans based on serum markers [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]
  • Assessment of time to rise in bone markers PINP and ICTP [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]
  • • Time to detection of bone metastases in bone scan [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]

Enrollment: 99
Study Start Date: February 2006
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Zoledronic acid
    In case of bone metastases: Zoledronic acid every 4 weeks for 3 months.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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/exclusion criteria may apply.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00391690

Locations
Germany
Novartis Investigative Site
Tuebingen, Germany
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmeceuticals
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00391690     History of Changes
Other Study ID Numbers: CZOL446GDE22
Study First Received: October 23, 2006
Last Updated: October 11, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
Serum bone marker
Prostate cancer
Bisphosphonates
Early detection of metastasis

Additional relevant MeSH terms:
Neoplasm Metastasis
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Neoplastic Processes
Pathologic Processes
Prostatic Diseases
Urogenital Neoplasms
Zoledronic acid
Bone Density Conservation Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014