A Trial of Strontium +/- Cisplatin for the Palliation of... | NCT00156884

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

NCT00156884

Sponsor

Alberta Health services

Status

Completed

Last Update Posted

Jan 19, 2012Estimated

Enrollment

58Estimated

Phase

Phase 2

Conditions

Hormone Refractory Prostate Cancer
Bone Metastases

Interventions

strontium-89
cisplatin

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2003

Primary Completion Date

May 2008Actual

Completion Date

May 2008Actual

First Submitted Date

Sep 8, 2005

First Submission Date that Met QC Criteria

Sep 8, 2005

First Posted Date

Sep 12, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 18, 2012

Last Update Posted Date

Jan 19, 2012Estimated

Name	Class
The Prostate Cancer Research Foundation of Canada	OTHER
Amersham Health	INDUSTRY

Description Module

Brief 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.

Detailed Description

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

58Estimated

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bernie Eigl, MD	Alberta Cancerboard	Principal Investigator
Jackson Wu	Alberta Cancerboard	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tom Baker Cancer Centre		Calgary	Alberta	T2N 4N2	Canada
BC Cancer Agency

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000615489	Strontium-89
D002945	Cisplatin

Ancestor Terms

ID	Term
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds

Browse Leaves

Not provided

Browse Branches

Not provided

Measure	Description	Time Frame
Palliative pain response
analgesic response

Name	Type	Description	Arm Group Labels	Other Names
strontium-89	Drug
cisplatin	Drug