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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 2
18 Years
N/A
Not Enrolling
Male
Hormone Refractory Prostate Cancer, Bone Metastases

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Trial Information

A Randomized Phase II Trial of Strontium-89 With or Without 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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Palliative pain response

Principal Investigator

Bernie Eigl, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Alberta Cancerboard

Authority:

Canada: Health Canada

Study ID:

GUPPS2

NCT ID:

NCT00156884

Start Date:

August 2003

Completion Date:

May 2008

Related Keywords:

  • Hormone Refractory Prostate Cancer
  • Bone Metastases
  • prostate cancer
  • cisplatin
  • strontium-89
  • phase II
  • Neoplasm Metastasis
  • Prostatic Neoplasms
  • Bone Neoplasms
  • Bone Marrow Diseases

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