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

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

MedlinePlus related topics:

Cancer Prostate Cancer

ChemIDplus related topics:

Cisplatin Strontium

U.S. FDA Resources

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

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:

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.

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

Study ID Numbers:	GUPPS2
First Received:	September 8, 2005
Last Updated:	August 13, 2008
ClinicalTrials.gov Identifier:	NCT00156884
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:

Cisplatin

Prostatic Diseases

Genital Neoplasms, Male

Neoplasm Metastasis

Urogenital Neoplasms

Pain

Genital Diseases, Male

Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms

Neoplastic Processes

Neoplasms by Site

Pathologic Processes

Radiation-Sensitizing Agents

Antineoplastic Agents

Therapeutic Uses

Physiological Effects of Drugs

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008

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