Hormone Refractory Prostate CancerPhase 2NCT00156884
A Trial of Strontium +/- Cisplatin for the Palliation of Bone Pain Secondary to Hormone Refractory Prostate Cancer
A Phase 2 study testing strontium-89 and cisplatin in people with Hormone Refractory Prostate Cancer and Bone Metastases, run by Alberta Health services at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Hormone Refractory Prostate Cancer, Bone Metastases
- What is being tested?
- strontium-89 and cisplatin
- How many people
- 58 participants
- Where
- 2 sitesCanada
- Study dates
- Aug 2003to May 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- ability to complete assessments
- prior treatment (chemo) > 4 weeks previous
- discontinued anti-androgens for > 4 weeks
Who cannot join
- 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
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- impending or present spinal cord compression
- significant neurological disorder
- impending pathological fracture
- severe urinary incontinence
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2
BC Cancer Agency
Vancouver, British Columbia
About this 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
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.
Read the 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.
- Being tested
- strontium-89, cisplatin
- Keywords
- prostate cancer, cisplatin, strontium-89, phase II
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
strontium-89Drug
cisplatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Palliative pain response
analgesic response
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startAug 2003
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hormone Refractory Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alberta Health services
- Sponsor type
- University, hospital or other
- Collaborators
- The Prostate Cancer Research Foundation of Canada, Amersham Health
- Investigators
- Bernie Eigl, MD, Principal investigator, Alberta CancerboardJackson Wu, Principal investigator, Alberta Cancerboard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00156884
- Sponsor's protocol ID
- GUPPS2
- Status last verified
- Aug 2008
- First submitted
- 8 Sep 2005
- Last updated
- 19 Jan 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00156884
- Acronym / sponsor ID
- GUPPS2
- Keywords
- prostate cancer, cisplatin, strontium-89, phase II
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Alberta Health servicesUniversity, hospital or other
- Collaborators
- The Prostate Cancer Research Foundation of Canada, Amersham Health
- Study start
- Aug 2003
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- adenocarcinoma of the prostate
- life expectancy > 3 months,
- symptomatic from bone metastases
- radiologic evidence of metastatic bone disease
- stable level of pain control
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| strontium-89 | Drug | – |
| cisplatin | Drug | – |
Primary outcome
Palliative pain response
analgesic response
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2012.
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ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernie Eigl, MD principal investigator
Alberta Cancerboard
Jackson Wu principal investigator
Alberta Cancerboard
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing strontium-89 and cisplatin in people with Hormone Refractory Prostate Cancer and Bone Metastases, run by Alberta Health services at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Palliative pain response. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2012.