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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

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

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

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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