Back to resultsA Trial of Strontium +/- Cisplatin for the Palliation of Bone Pain Secondary to Hormone Refractory Prostate Cancer
Primary Purpose
Hormone Refractory Prostate Cancer, Bone Metastases
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
strontium-89
cisplatin
Sponsored by
About this trial
This is an interventional treatment trial for Hormone Refractory Prostate Cancer focused on measuring prostate cancer, cisplatin, strontium-89, phase II
Eligibility Criteria
Inclusion Criteria: adenocarcinoma of the prostate life expectancy > 3 months, symptomatic from bone metastases radiologic evidence of metastatic bone disease stable level of pain control >18 years ability to complete assessments prior treatment (chemo) > 4 weeks previous discontinued anti-androgens for > 4 weeks Exclusion Criteria: prior strontium therapy previous hemibody RT within 6 weeks previous cytotoxic chemotherapy within 4 weeks use of bisphosphonate medications within 4 weeks change in steroid dose within 4 weeks active uncontrolled infection impending or present spinal cord compression significant neurological disorder impending pathological fracture severe urinary incontinence
Sites / Locations
- Tom Baker Cancer Centre
- BC Cancer Agency
Outcomes
Primary Outcome Measures
Palliative pain response
analgesic response
Secondary Outcome Measures
Full Information
NCT ID
NCT00156884
First Posted
September 8, 2005
Last Updated
January 18, 2012
Sponsor
Alberta Health services
Collaborators
The Prostate Cancer Research Foundation of Canada, Amersham Health
1. Study Identification
Unique Protocol Identification Number
NCT00156884
Brief Title
A Trial of Strontium +/- Cisplatin for the Palliation of Bone Pain Secondary to Hormone Refractory Prostate Cancer
Official Title
A Randomized Phase II Trial of Strontium-89 With or Without Cisplatin for the Palliation of Bone Pain Secondary to Hormone Refractory Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Alberta Health services
Collaborators
The Prostate Cancer Research Foundation of Canada, Amersham Health
4. Oversight
5. Study Description
Brief Summary
This study is designed to determine whether the combination of low dose cisplatin and strontium-89 shows clinical promise for the symptomatic treatment of bone metastases in hormone refractory prostate cancer.
Detailed Description
This study is designed to determine whether the combination of low dose cisplatin and strontium-89 shows clinical promise for the symptomatic treatment of bone metastases in hormone refractory prostate cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hormone Refractory Prostate Cancer, Bone Metastases
Keywords
prostate cancer, cisplatin, strontium-89, phase II
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
strontium-89
Intervention Type
Drug
Intervention Name(s)
cisplatin
Primary Outcome Measure Information:
Title
Palliative pain response
Title
analgesic response
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adenocarcinoma of the prostate
life expectancy > 3 months,
symptomatic from bone metastases
radiologic evidence of metastatic bone disease
stable level of pain control
>18 years
ability to complete assessments
prior treatment (chemo) > 4 weeks previous
discontinued anti-androgens for > 4 weeks
Exclusion Criteria:
prior strontium therapy
previous hemibody RT within 6 weeks
previous cytotoxic chemotherapy within 4 weeks
use of bisphosphonate medications within 4 weeks
change in steroid dose within 4 weeks
active uncontrolled infection
impending or present spinal cord compression
significant neurological disorder
impending pathological fracture
severe urinary incontinence
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernie Eigl, MD
Organizational Affiliation
Alberta Cancerboard
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jackson Wu
Organizational Affiliation
Alberta Cancerboard
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
BC Cancer Agency
City
Vancouver
State/Province
British Columbia
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A Trial of Strontium +/- Cisplatin for the Palliation of Bone Pain Secondary to Hormone Refractory Prostate Cancer
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