AzTrials
AzTrials

Prostate CancerPhase 4NCT00391690

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

A Phase 4 study testing Zoledronic acid in people with Prostate Cancer, run by Novartis at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Zoledronic acid
How many people
99 participants
Where
1 siteGermany
Study dates
Feb 2006to Dec 2010
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Novartis Investigative Site

    Tübingen

Other trials in Germany

About this study

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
Being tested
Zoledronic acid
Keywords
Serum bone marker, Prostate cancer, Bisphosphonates, Early detection of metastasis
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Zoledronic acidDrug

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

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Every 3 months

Secondary outcomes (6)

  1. 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)

    Measured: Every 3 months

  2. Assessment of course of Prostate-specific antigen (PSA)

    Measured: Every 3 months

  3. Assessment of correlation of bone parameters and PSA

    Measured: Every 3 months

  4. Assessment of optimal intervals for bone scans based on serum markers

    Measured: Every 3 months

  5. Assessment of time to rise in bone markers PINP and ICTP

    Measured: Every 3 months

  6. • Time to detection of bone metastases in bone scan

    Measured: Every 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2006 (estimated)
  2. Study startFeb 2006
  3. Primary completionDec 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
99 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00391690
Sponsor's protocol ID
CZOL446GDE22
Status last verified
Nov 2016
First submitted
23 Oct 2006
Last updated
18 Nov 2016
Results posted
No

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.

    PubMed 19143027

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Zoledronic acid in people with Prostate Cancer, run by Novartis at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

• To assess the relationship between change in bone parameters and bone scan with respect to bone metastases (time frame: Every 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00391690, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2016.

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