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

A Randomized Phase II Trial of Strontium-89 With or Without Cisplatin for the Palliation of Bone Pain Secondary to Hormone Refractory Prostate Cancer

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00156884
Enrollment
58
Registered
2005-09-12
Start date
2003-08-31
Completion date
2008-05-31
Last updated
2012-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Metastases, Hormone Refractory Prostate Cancer

Keywords

prostate cancer, cisplatin, strontium-89, phase II

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

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.

Interventions

DRUGstrontium-89
DRUGcisplatin

Sponsors

The Prostate Cancer Research Foundation of Canada
CollaboratorOTHER
Amersham Health
CollaboratorINDUSTRY
Alberta Health services
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Palliative pain response
analgesic response

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026