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Assessment of the Efficacy and Safety of Zoledronic Acid in the Treatment of Bone Metastases-related Pain in Patients With Prostate Cancer


Phase 3
18 Years
N/A
Not Enrolling
Male
Pain

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Trial Information

Assessment of the Efficacy and Safety of Zoledronic Acid in the Treatment of Bone Metastases-related Pain in Patients With Prostate Cancer


Inclusion Criteria:



- Histologically proven adenocarcinoma of the prostate

- Bone-scan documented metastases

- Age > 18 years

- Non-controlled bone pain despite systemic anti-tumor therapy (hormone or
chemotherapy) initiated at least 4 weeks before inclusion

- Life expectancy > 3 months

- Written informed consent

Exclusion Criteria:

- New systemic anti-tumor therapy initiated less than 4 weeks before study entry or
predictable need for starting a new treatment within 8 weeks

- Radiation therapy on bone target lesions or bone-targeted isotope therapy (strontium
or samarium) completed less than 4 weeks before study entry

- Bisphosphonate therapy within 8 weeks before study entry

- Abnormal renal function (serum creatinine > 2 x the upper normal limit or creatinine
clearance < 30 ml/min)

- Corrected serum calcium > 3 mmol/L or < 2 mmol/L

- Clinically relevant hypersensitivity to zoledronic acid, or another bisphosphonate,
or one component present in the formulation of the study drug

- Severe concomitant medical condition that could hamper patient's quality of life or
influence the interpretation of pain

- Patients unable to fill in a questionnaire (neurologic or psychiatric conditions,
illiteracy, etc.)

Other protocol-defined exclusion criteria may apply.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

to measure the intensity of the pain relief of the patients at the end of treatment with a five classes score (TOTPAR = TOTal PAin Relief)

Outcome Time Frame:

at 12 weeks or at 16 weeks (end of treatment)

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

CZOL446EFR08

NCT ID:

NCT00375648

Start Date:

June 2005

Completion Date:

Related Keywords:

  • Pain
  • Prostate
  • Cancer
  • Bone metastases
  • Zoledronic acid
  • Bone metastases-related pain
  • Prostate cancer
  • Neoplasm Metastasis
  • Prostatic Neoplasms
  • Bone Neoplasms
  • Bone Marrow Diseases

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