NCT00156884

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2003

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

January 19, 2012

Status Verified

August 1, 2008

Enrollment Period

4.8 years

First QC Date

September 8, 2005

Last Update Submit

January 18, 2012

Conditions

Hormone Refractory Prostate CancerBone Metastases

Keywords

prostate cancercisplatinstrontium-89phase II

Outcome Measures

Primary Outcomes (2)

  • Palliative pain response

  • analgesic response

Interventions

strontium-89DRUG
cisplatinDRUG

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

Location

BC Cancer Agency

Vancouver, British Columbia, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Strontium-89Cisplatin

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Bernie Eigl, MD

    Alberta Cancerboard

    PRINCIPAL INVESTIGATOR

  • Jackson Wu

    Alberta Cancerboard

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

August 1, 2003

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

January 19, 2012

Record last verified: 2008-08

Locations

CA(2)