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

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)