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

NCT ID: NCT00156884

Last Updated: 2012-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-08-31

Study Completion Date

2008-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hormone Refractory Prostate Cancer Bone Metastases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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strontium-89

Intervention Type DRUG

cisplatin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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The Prostate Cancer Research Foundation of Canada

OTHER

Sponsor Role collaborator

Amersham Health

INDUSTRY

Sponsor Role collaborator

Alberta Health services

OTHER

Sponsor Role lead

Principal Investigators

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Bernie Eigl, MD

Role: PRINCIPAL_INVESTIGATOR

Alberta Cancerboard

Jackson Wu

Role: PRINCIPAL_INVESTIGATOR

Alberta Cancerboard

Locations

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Tom Baker Cancer Centre

Calgary, Alberta, Canada

Site Status

BC Cancer Agency

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

Other Identifiers

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GUPPS2

Identifier Type: -

Identifier Source: org_study_id

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