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A Trial of Strontium +/- Cisplatin for the Palliation of Bone Pain Secondary to Hormone Refractory Prostate Cancer

This study has been completed.
Sponsor:
Collaborators:
Prostate cancer research foundation
Amersham Health
Information provided by:
Alberta Health Services
ClinicalTrials.gov Identifier:
NCT00156884
First received: September 8, 2005
Last updated: January 18, 2012
Last verified: August 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Hormone Refractory Prostate Cancer
Bone Metastases
 Drug: strontium-89
Drug: cisplatin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Cisplatin
U.S. FDA Resources

Further study details as provided by Alberta Health Services:

Primary Outcome Measures:
  • Palliative pain response
  • analgesic response

Estimated Enrollment: 58
Study Start Date: August 2003
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00156884

Locations
Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
Canada, British Columbia
BC Cancer Agency
Vancouver, British Columbia, Canada
Sponsors and Collaborators
Alberta Health Services
Prostate cancer research foundation
Amersham Health
Investigators
Principal Investigator: Bernie Eigl, MD Alberta Cancerboard
Principal Investigator: Jackson Wu Alberta Cancerboard
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00156884     History of Changes
Other Study ID Numbers: GUPPS2
Study First Received: September 8, 2005
Last Updated: January 18, 2012
Health Authority: Canada: Health Canada

Keywords provided by Alberta Health Services:
prostate cancer
cisplatin
strontium-89
phase II

Additional relevant MeSH terms:
Neoplasm Metastasis
Prostatic Neoplasms
Bone Neoplasms
Bone Marrow Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
 Prostatic Diseases
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013