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

A

Alberta Health services

Status and phase

Completed
Phase 2

Conditions

Hormone Refractory Prostate Cancer
Bone Metastases

Treatments

Drug: cisplatin
Drug: strontium-89

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00156884
GUPPS2

Details and patient eligibility

About

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.

Full 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.

Enrollment

58 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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