Prostate CancerPhase 3NCT00489060
A Randomized Trial of External Beam Radiotherapy Versus Cryoablation in Patients With Localized Prostate Cancer
A Phase 3 study testing Cryoablation and External Beam Radiation in people with Prostate Cancer, run by University of Calgary at 1 site in Canada.
Trial summary
A trial to determine if cryoablation is as effective as radiation in the treatment of men with localized prostate cancer. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Cryoablation and External Beam Radiation
- Type of treatment
- Surgery or procedure
- How many people
- 244 participants
- Where
- 1 siteCanada
- Study dates
- Dec 1997to Apr 2007
- Phase
- Phase 3
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinically localized prostate cancer
- PSA < 20ng/ml
- Negative bone scan
Who cannot join
- Previous TURP
- Previous hormone therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Trial of External Beam Radiotherapy Versus Cryoablation in Patients With Clinically Localized Prostate Cancer
A trial to determine if cryoablation is as effective as radiation in the treatment of men with localized prostate cancer.
Read the detailed description
Men with newly diagnosed localized prostate cancer were randomly assigned to cryoablation or external beam radiotherapy (median dose 68 Gy). All patients received neoadjuvant antiandrogen therapy. The primary endpoint was disease progression at 36 months based on a trifecta definition of failure: (a) radiological evidence of metastatic disease or b) initiation of further antineoplastic therapy or c) biochemical failure). Two definitions of biochemical failure were used: 1) rising PSA with a final value >1.0 ng/mL and 2) rise above PSA nadir + 2 ng/mL. Secondary endpoints were overall survival, disease-specific survival, and positive prostate biopsy at 36 months.
- Conditions
- Prostate Cancer
- Being tested
- Cryoablation and External Beam Radiation
- Keywords
- Cryoablation, Radiation, Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryoablation and External Beam RadiationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
No evidence of disease progression (NEDP) at 36 months
Measured: 36 months
Secondary outcomes (1)
Prostate biopsy status
Measured: 36 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2007 (estimated)
- Study startDec 1997
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Cancer Trials Group, AHS Cancer Control Alberta
- Investigators
- Bryan Donnelly, MD, Principal investigator, Tom Baker Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00489060
- Sponsor's protocol ID
- 9716
- Status last verified
- Jul 2008
- First submitted
- 20 Jun 2007
- Last updated
- 17 Jul 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of External Beam Radiotherapy Versus Cryoablation in Patients With Clinically Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT00489060
- Acronym / sponsor ID
- 9716
- Conditions
- Prostate Cancer
- Keywords
- Cryoablation, Radiation, Prostate Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Canadian Cancer Trials Group, AHS Cancer Control Alberta
- Study start
- Dec 1997
- Study completion
- Apr 2007 (actual)
- First posted
- 21 Jun 2007 (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.
A trial to determine if cryoablation is as effective as radiation in the treatment of men with localized prostate cancer.
Detailed description
Men with newly diagnosed localized prostate cancer were randomly assigned to cryoablation or external beam radiotherapy (median dose 68 Gy). All patients received neoadjuvant antiandrogen therapy. The primary endpoint was disease progression at 36 months based on a trifecta definition of failure: (a) radiological evidence of metastatic disease or b) initiation of further antineoplastic therapy or c) biochemical failure). Two definitions of biochemical failure were used: 1) rising PSA with a final value >1.0 ng/mL and 2) rise above PSA nadir + 2 ng/mL. Secondary endpoints were overall survival, disease-specific survival, and positive prostate biopsy at 36 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Clinically localized prostate cancer
- PSA < 20ng/ml
- Negative bone scan
Key exclusion criteria (2 listed)
- Previous TURP
- Previous hormone therapy
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 |
|---|---|---|
| Cryoablation and External Beam Radiation | Procedure or surgery | – |
Primary outcome
No evidence of disease progression (NEDP) at 36 months
Time frame: 36 months
1 secondary outcome
Prostate biopsy status
Time frame: 36 months post treatment
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 17 Jul 2008.
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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.
Bryan Donnelly, MD principal investigator
Tom Baker Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cryoablation and External Beam Radiation in people with Prostate Cancer, run by University of Calgary at 1 site 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 3 inclusion and 2 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 17 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
No evidence of disease progression (NEDP) at 36 months (time frame: 36 months). 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 17 Jul 2008.