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Completed

NCT Number: NCT00156884

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

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.

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Key information

Conditions

Hormone Refractory Prostate Cancer Bone Metastases Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Tom Baker Cancer Centre, Calgary, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

strontium-89

Drug

Cisplatin

Drug

Primary outcomes

  1. Palliative pain response

  2. analgesic response

Sponsors and collaborators

Lead sponsor

Alberta Health services

Other

Collaborators

  • Amersham Health
  • The Prostate Cancer Research Foundation of Canada

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Sep 12, 2005
Registry last updated
Jan 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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