Prostate CancerCEASARNCT01326286
Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) for Localized Prostate Cancer
An observational study of Prostate Cancer, run by Vanderbilt University at 5 sites in United States.
Trial summary
This study will primarily compare the effectiveness of surgery and radiation for localized prostate cancer, the most common male cancer. It will focus on modern technologies and control for differences in patients and treatments that may affect both cancer-related and patient-reported outcomes (such as impotence and… Read more about this study
- Who is it for?
- Ages 18 to 79 years, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 3,265 participants
- Where
- 5 sitesUnited States
- Study dates
- Mar 2011to Sep 2018
- Phase
- Observational
- 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 to 79 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Population-based sample of men diagnosed with localized prostate cancer in the states of Louisiana and New Jersey and the metropolitan areas of Atlanta and Los Angeles, augmented with a convenience sample of men enrolled in the CaPSURE database, a national observational disease registry.
Who may be able to join
- Pathologic diagnosis of adenocarcinoma of the prostate
- Clinically localized stage
- PSA <50ng/ml
- age 18-79
Who cannot join
- diagnosis of other malignancy (excluding squamous or basal cell carcinoma of the skin) within 3 years of diagnosis of prostate cancer
- age 80 or greater
- clinically locally advanced or metastatic disease
- PSA equal to or greater than 50 ng/ml
- pathologic diagnosis of prostate cancer greater than 6 months prior to baseline recruitment interview
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Emory University
Atlanta, Georgia, 30322
University of Southern California
Los Angeles, California, 90033
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Lousiana State University Health Sciences Center- New Orleans
New Orleans, Louisiana, 70112
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Comparative Effectiveness Study of Various Treatments for Localized Prostate Cancer
This study will primarily compare the effectiveness of surgery and radiation for localized prostate cancer, the most common male cancer. It will focus on modern technologies and control for differences in patients and treatments that may affect both cancer-related and patient-reported outcomes (such as impotence and incontinence). By figuring out what treatments "work best, in which patients and in whose hands", it will help men with prostate cancer make better decisions regarding their care.
Read the detailed description
Prostate cancer is the most common solid tumor and the second leading cause of cancer death among American men. While surgery, radiation and observation have all been deemed appropriate for newly diagnosed men, tremendous uncertainty remains regarding the optimal treatment. AHRQ's 2008 evidence report on the comparative effectiveness of therapies for localized prostate cancer concluded that "no one therapy can be considered the preferred treatment for localized prostate cancer due to the limitations in the body of evidence as well as the likely tradeoffs an individual patient must make between estimated treatment effectiveness, necessity and adverse effects." The existing literature is limited by its focus on older therapeutic modalities and failure to control for individual patient characteristics and provider/hospital characteristics that may influence outcomes (quality of care). To fill these evidence gaps, we propose to expand a network of state tumor registries and a national observational disease registry to establish a new population-based cohort of men newly diagnosed with localized prostate cancer. We will prospectively measure key patient-reported outcomes, such as health-related quality of life and side-effects of therapy at diagnosis and 6 and 12 months later. We will also collect detailed medical record information, including clinical data, technical details of the interventions, complications, short-term cancer recurrence rates, and quality-of-care indicators.
By using this approach, we will overcome limitations of the extant literature and achieve the following specific aims:
- To compare the effectiveness of contemporary surgical and radiation techniques for localized prostate cancer in the cohort described above in terms of the 6- and 12-month patient-reported outcomes, side-effects and complications of treatment.
- To identify patient level characteristics that may influence comparative effectiveness.
- To assess how the comparative effectiveness of the various therapies varies by quality of care received.
- Conditions
- Prostate Cancer
- Keywords
- Comparative Effectiveness Research, Prostatectomy, radiotherapy, quality of life
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Open Radical Prostatectomy | 262 | |
| Robotic Radical Prostatectomy | 1303 | |
| Intensity-Modulated Radiotherapy | 638 | |
| Interstitial Brachytherapy | 171 | |
| combined EBRT and Brachytherapy | 143 | |
| Active Surveillance | 448 | |
| Various other treatments | 300 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-Specific Health-Related Quality of Life (EPIC)
Sexual, urinary, bowel and hormonal function and bother subscores will be assessed
Measured: 12, 24 and 60 months after enrollment
Secondary outcomes (3)
cancer-free survival
assessed using PSA levels obtained from medical record review
Measured: 6 and 12 months after enrollment
Complications of treatment
data collected from patient report and medical record review
Measured: 6- and 12-months after enrollment
General Health-Related Quality of Life (SF-12)
Measured: 6- and 12-months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionAug 2017
- Study completionSep 2018
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,265 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Agency for Healthcare Research and Quality (AHRQ), Louisiana State University Health Sciences Center in New Orleans, University of California, Irvine, University of California, San Francisco, University of Southern California, M.D. Anderson Cancer Center, University of Utah, Emory University, Rutgers Cancer Institute of New Jersey
- Responsible party
- Principal investigator, David Penson, Vanderbilt University
- Investigators
- David F Penson, MD, MPH, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01326286
- Sponsor's protocol ID
- 110299
- Other IDs
- 1R01HS019356-01, CE grant, 1R01HS022640-01
- Acronym
- CEASAR
- Status last verified
- Sep 2018
- First submitted
- 25 Mar 2011
- Last updated
- 26 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness Study of Various Treatments for Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT01326286
- Acronym / sponsor ID
- CEASAR / 110299
- Conditions
- Prostate Cancer
- Keywords
- Comparative Effectiveness Research, Prostatectomy, radiotherapy, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,265 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Agency for Healthcare Research and Quality (AHRQ), Louisiana State University Health Sciences Center in New Orleans, University of California, Irvine, University of California, San Francisco, University of Southern California, M.D. Anderson Cancer Center, University of Utah, Emory University, Rutgers Cancer Institute of New Jersey
- Study start
- Mar 2011 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 30 Mar 2011 (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 will primarily compare the effectiveness of surgery and radiation for localized prostate cancer, the most common male cancer. It will focus on modern technologies and control for differences in patients and treatments that may affect both cancer-related and patient-reported outcomes (such as impotence and incontinence). By figuring out what treatments "work best, in which patients and in whose hands", it will help men with prostate cancer make better decisions regarding their care.
Detailed description
Prostate cancer is the most common solid tumor and the second leading cause of cancer death among American men. While surgery, radiation and observation have all been deemed appropriate for newly diagnosed men, tremendous uncertainty remains regarding the optimal treatment. AHRQ's 2008 evidence report on the comparative effectiveness of therapies for localized prostate cancer concluded that "no one therapy can be considered the preferred treatment for localized prostate cancer due to the limitations in the body of evidence as well as the likely tradeoffs an individual patient must make between estimated treatment effectiveness, necessity and adverse effects." The existing literature is limited by its focus on older therapeutic modalities and failure to control for individual patient characteristics and provider/hospital characteristics that may influence outcomes (quality of care). To fill these evidence gaps, we propose to expand a network of state tumor registries and a national observational disease registry to establish a new population-based cohort of men newly diagnosed with localized prostate cancer. We will prospectively measure key patient-reported outcomes, such as health-related quality of life and side-effects of therapy at diagnosis and 6 and 12 months later. We will also collect detailed medical record information, including clinical data, technical details of the interventions, complications, short-term cancer recurrence rates, and quality-of-care indicators.
By using this approach, we will overcome limitations of the extant literature and achieve the following specific aims:
- To compare the effectiveness of contemporary surgical and radiation techniques for localized prostate cancer in the cohort described above in terms of the 6- and 12-month patient-reported outcomes, side-effects and complications of treatment.
- To identify patient level characteristics that may influence comparative effectiveness.
- To assess how the comparative effectiveness of the various therapies varies by quality of care received.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Open Radical Prostatectomy | – | –262 |
| Robotic Radical Prostatectomy | – | –1303 |
| Intensity-Modulated Radiotherapy | – | –638 |
| Interstitial Brachytherapy | – | –171 |
| combined EBRT and Brachytherapy | – | –143 |
| Active Surveillance | – | –448 |
| Various other treatments | – | –300 |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population-based sample of men diagnosed with localized prostate cancer in the states of Louisiana and New Jersey and the metropolitan areas of Atlanta and Los Angeles, augmented with a convenience sample of men enrolled in the CaPSURE database, a national observational disease registry.
Key inclusion criteria (4 listed)
- Pathologic diagnosis of adenocarcinoma of the prostate
- Clinically localized stage
- PSA <50ng/ml
- age 18-79
Key exclusion criteria (5 listed)
- diagnosis of other malignancy (excluding squamous or basal cell carcinoma of the skin) within 3 years of diagnosis of prostate cancer
- age 80 or greater
- clinically locally advanced or metastatic disease
- PSA equal to or greater than 50 ng/ml
- pathologic diagnosis of prostate cancer greater than 6 months prior to baseline recruitment interview
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Disease-Specific Health-Related Quality of Life (EPIC)
Time frame: 12, 24 and 60 months after enrollment
Sexual, urinary, bowel and hormonal function and bother subscores will be assessed
3 secondary outcomes
cancer-free survival
Time frame: 6 and 12 months after enrollment
Complications of treatment
Time frame: 6- and 12-months after enrollment
General Health-Related Quality of Life (SF-12)
Time frame: 6- and 12-months after enrollment
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 26 Sep 2018.
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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.
David F Penson, MD, MPH principal investigator
Vanderbilt University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Vanderbilt University at 5 sites in United States.
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 4 inclusion and 5 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 26 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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.
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?
Disease-Specific Health-Related Quality of Life (EPIC) (time frame: 12, 24 and 60 months after enrollment). 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 26 Sep 2018.