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

NCT00391690 | Completed Phase 4

• 1 other identifier: CZOL446GDE22
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Serum bone marker; Prostate cancer; Bisphosphonates; Early detection of metastasis

Outcome Measures

Primary Outcomes (1)

• • To assess the relationship between change in bone parameters and bone scan with respect to bone metastases

  Every 3 months

Secondary Outcomes (6)

• 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 course of Prostate-specific antigen (PSA)

  Every 3 months

• Assessment of correlation of bone parameters and PSA

  Every 3 months

• Assessment of optimal intervals for bone scans based on serum markers

  Every 3 months

• Assessment of time to rise in bone markers PINP and ICTP

  Every 3 months

Interventions

Zoledronic acid DRUG

In case of bone metastases: Zoledronic acid every 4 weeks for 3 months.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Novartis Investigative Site

Tübingen, Germany

Location

Related Publications (1)

• 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.

  PMID: 19143027 RESULT

Related Links

• Embasse # 200925640

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmeceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2006
• First Posted: October 24, 2006
• Study Start: February 1, 2006
• Primary Completion: December 1, 2010
• Last Updated: November 18, 2016

Record last verified: 2016-11

Locations

DE (1)