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

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ClinicalTrials.gov Identifier: NCT00156884
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : January 19, 2012
Sponsor:
Collaborators:
The Prostate Cancer Research Foundation of Canada
Amersham Health
Information provided by:
AHS Cancer Control Alberta

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.

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

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2003
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

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




Primary Outcome Measures :
  1. Palliative pain response
  2. analgesic response


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
The Prostate Cancer Research Foundation of Canada
Amersham Health
Investigators
Principal Investigator: Bernie Eigl, MD Alberta Cancerboard
Principal Investigator: Jackson Wu Alberta Cancerboard

ClinicalTrials.gov Identifier: NCT00156884     History of Changes
Other Study ID Numbers: GUPPS2
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: January 19, 2012
Last Verified: August 2008

Keywords provided by AHS Cancer Control Alberta:
prostate cancer
cisplatin
strontium-89
phase II

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Cisplatin
Hormones
Antineoplastic Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs