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

Bone Metastases Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00156884
• Other study ID #: GUPPS2
• Status: Completed
• Phase: Phase 2
• First received: September 8, 2005
• Last updated: January 18, 2012
• Start date: August 2003
• Est. completion date: May 2008

Study information

• Verified date: August 2008
• Source: AHS Cancer Control Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Bone Metastases
• Hormone Refractory Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• strontium-89

• cisplatin

Locations

Country	Name	City	State
Canada	Tom Baker Cancer Centre	Calgary	Alberta
Canada	BC Cancer Agency	Vancouver	British Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Alberta Health Services	Amersham Health, The Prostate Cancer Research Foundation of Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Palliative pain response
Primary	analgesic response