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

This study has been completed.

First Received: September 8, 2005 Last Updated: August 13, 2008 History of Changes

Sponsors and Collaborators:	Alberta Cancer Board Prostate cancer research foundation Amersham
Information provided by:	Alberta Cancer Board
ClinicalTrials.gov Identifier:	NCT00156884

Purpose

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.

Condition	Intervention	Phase
Hormone Refractory Prostate Cancer Bone Metastases	Drug: strontium-89 Drug: cisplatin	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Cisplatin Strontium

U.S. FDA Resources

Further study details as provided by Alberta Cancer Board:

Primary Outcome Measures:

Palliative pain response
analgesic response

Estimated Enrollment:	58
Study Start Date:	August 2003
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Detailed Description:

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00156884

Locations

Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
Canada, British Columbia
BC Cancer Agency
Vancouver, British Columbia, Canada

Sponsors and Collaborators

Alberta Cancer Board

Prostate cancer research foundation

Amersham

Investigators

Principal Investigator:	Bernie Eigl, MD	Alberta Cancerboard
Principal Investigator:	Jackson Wu	Alberta Cancerboard

More Information

No publications provided

Study ID Numbers:	GUPPS2
Study First Received:	September 8, 2005
Last Updated:	August 13, 2008
ClinicalTrials.gov Identifier:	NCT00156884 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by Alberta Cancer Board:

prostate cancer
cisplatin
strontium-89
phase II

Study placed in the following topic categories:

Radiation-Sensitizing Agents
Cisplatin
Prostatic Diseases
Genital Neoplasms, Male
Neoplasm Metastasis

Urogenital Neoplasms
Pain
Genital Diseases, Male
Hormones
Prostatic Neoplasms

Additional relevant MeSH terms:

Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Urogenital Neoplasms
Genital Diseases, Male
Pharmacologic Actions
Neoplastic Processes

Neoplasms
Pathologic Processes
Neoplasms by Site
Radiation-Sensitizing Agents
Cisplatin
Therapeutic Uses
Neoplasm Metastasis
Prostatic Neoplasms

ClinicalTrials.gov processed this record on September 11, 2009