Trial | NCT00156884  Report issue

Title

A Trial of Strontium +/- Cisplatin for the Palliation of Bone Pain Secondary to Hormone Refractory Prostate Cancer
A Randomized Phase II Trial of Strontium-89 With or Without Cisplatin for the Palliation of Bone Pain Secondary to Hormone Refractory Prostate Cancer

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Indication/Condition

    Bone Metastases ...

  • Study Participants

    58
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.
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 Started
Aug 31
2003
Primary Completion
May 31
2008
Study Completion
May 31
2008
Last Update
Jan 19
2012
Estimate

Drug strontium-89

Drug cisplatin

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
No Results Posted