Efficacy and Safety of Zoledronic Acid in the Treatment of Bone Metastases-related Pain in Patients With Prostate Cancer (TRAPEZE)
Primary Purpose
Pain
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Zoledronic acid
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring Prostate, Cancer, Bone metastases, Zoledronic acid, Bone metastases-related pain, Prostate cancer
Eligibility Criteria
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.
Sites / Locations
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
zoledronate
Arm Description
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
To measure the intensity of the pain relief of the patients with the PAR at each visit
To evaluate the pain variation with VAS between V1 and V2, V3, V4, V5.
To evaluate the pain variation with BPI (=Brief Pain Inventory) and correlate with VAS (=Visual Analog Scale)
To evaluate the use of analgesic (analgesic score) and the number of patients needing an analgesic radiotherapy between V1 and V5
To evaluate the duration of responses
To evaluate the number of skeletal related events by patient
To evaluate the effect on functional disability, professional activity (BPI), the PS and overall condition (VAS) between V1 and V5
To evaluate the variations of PSA (=Prostate specific Antigen) between V1 and End of study or premature withdrawal
Full Information
NCT ID
NCT00375648
First Posted
September 11, 2006
Last Updated
May 31, 2017
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00375648
Brief Title
Efficacy and Safety of Zoledronic Acid in the Treatment of Bone Metastases-related Pain in Patients With Prostate Cancer
Acronym
TRAPEZE
Official Title
Assessment of the Efficacy and Safety of Zoledronic Acid in the Treatment of Bone Metastases-related Pain in Patients With Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
5. Study Description
Brief Summary
This study will evaluate the efficacy and safety of 4 mg zoledronic acid administered intravenously every 3-4 weeks in the treatment of bone metastases-related pain in patients with prostate cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
Prostate, Cancer, Bone metastases, Zoledronic acid, Bone metastases-related pain, Prostate cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
zoledronate
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Zoledronic acid
Primary Outcome Measure Information:
Title
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)
Time Frame
at 12 weeks or at 16 weeks (end of treatment)
Secondary Outcome Measure Information:
Title
To measure the intensity of the pain relief of the patients with the PAR at each visit
Time Frame
every 3 or 4 weeks during 12 to 16 weeks
Title
To evaluate the pain variation with VAS between V1 and V2, V3, V4, V5.
Time Frame
every 3 or 4 weeks during 12 to 16 weeks
Title
To evaluate the pain variation with BPI (=Brief Pain Inventory) and correlate with VAS (=Visual Analog Scale)
Time Frame
every 3 or 4 weeks during 12 to 16 weeks
Title
To evaluate the use of analgesic (analgesic score) and the number of patients needing an analgesic radiotherapy between V1 and V5
Time Frame
every 3 or 4 weeks during 12 to 16 weeks
Title
To evaluate the duration of responses
Time Frame
at 12 weeks or at 16 weeks (end of treatment)
Title
To evaluate the number of skeletal related events by patient
Time Frame
every 3 or 4 weeks during 12 to 16 weeks
Title
To evaluate the effect on functional disability, professional activity (BPI), the PS and overall condition (VAS) between V1 and V5
Time Frame
every 3 or 4 weeks during 12 to 16 weeks
Title
To evaluate the variations of PSA (=Prostate specific Antigen) between V1 and End of study or premature withdrawal
Time Frame
at 12 weeks or at 16 weeks (end of treatment)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Monpellier
Country
France
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Zoledronic Acid in the Treatment of Bone Metastases-related Pain in Patients With Prostate Cancer
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