- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00391690
Evaluation of Bone Markers as Diagnostic Tools for Early Detection of Bone Metastases in Patients With High Risk Prostate Cancer
16. november 2016 opdateret af: 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.
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
99
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Tuebingen, Tyskland
- Novartis Investigative Site
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Han
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
• To assess the relationship between change in bone parameters and bone scan with respect to bone metastases
Tidsramme: Every 3 months
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Every 3 months
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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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)
Tidsramme: Every 3 months
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Every 3 months
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Assessment of course of Prostate-specific antigen (PSA)
Tidsramme: Every 3 months
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Every 3 months
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Assessment of correlation of bone parameters and PSA
Tidsramme: Every 3 months
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Every 3 months
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Assessment of optimal intervals for bone scans based on serum markers
Tidsramme: Every 3 months
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Every 3 months
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Assessment of time to rise in bone markers PINP and ICTP
Tidsramme: Every 3 months
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Every 3 months
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• Time to detection of bone metastases in bone scan
Tidsramme: Every 3 months
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Every 3 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. februar 2006
Primær færdiggørelse (Faktiske)
1. december 2010
Datoer for studieregistrering
Først indsendt
23. oktober 2006
Først indsendt, der opfyldte QC-kriterier
23. oktober 2006
Først opslået (Skøn)
24. oktober 2006
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
18. november 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. november 2016
Sidst verificeret
1. november 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CZOL446GDE22
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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