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

November 16, 2016 updated by: Novartis

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.

Study Overview

Status

Completed

Conditions

Prostate Cancer

Intervention / Treatment

Drug: Zoledronic acid

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Germany
- - Tuebingen, Germany
    - Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
• To assess the relationship between change in bone parameters and bone scan with respect to bone metastases Time Frame: Every 3 months	Every 3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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	Every 3 months
Assessment of course of Prostate-specific antigen (PSA) Time Frame: Every 3 months	Every 3 months
Assessment of correlation of bone parameters and PSA Time Frame: Every 3 months	Every 3 months
Assessment of optimal intervals for bone scans based on serum markers Time Frame: Every 3 months	Every 3 months
Assessment of time to rise in bone markers PINP and ICTP Time Frame: Every 3 months	Every 3 months
• Time to detection of bone metastases in bone scan Time Frame: Every 3 months	Every 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Lein M, Miller K, Wirth M, Weissbach L, May C, Schmidt K, Haus U, Schrader M, Jung K. Bone turnover markers as predictive tools for skeletal complications in men with metastatic prostate cancer treated with zoledronic acid. Prostate. 2009 May 1;69(6):624-32. doi: 10.1002/pros.20917.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

October 23, 2006

First Submitted That Met QC Criteria