Prostate CancerPhase 3PIVOTNCT00007644
Prostate Cancer Intervention Versus Observation Trial (PIVOT)
A Phase 3 study testing Radical prostatectomy in people with Prostate Cancer, run by VA Office of Research and Development at 31 sites in United States.
Trial summary
Radical prostatectomy provides potentially curative removal of the cancer. However, it subjects patients to the morbidity and mortality of the surgery and may be neither necessary nor effective. Expectant management does not offer potential cure. Read more about this study
- Who is it for?
- Ages Up to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Radical prostatectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 731 participants
- Where
- 31 sitesUnited States
- Study dates
- Nov 1994to Jan 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 75 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with clinically localized CAP
- Diagnosis of Prostate Cancer within previous 6 months
- Age 75 years or younger
Who cannot join
- PSA > 50 ng/ml Bone scan consistent with metastatic disease Other evidence that cancer of the prostate is not clinically localized Diagnosis of prostate cancer greater than 12 months ago Life expectancy less than 10 years Serum creatinine greater than 3 mg/dl Myocardial infarction within last 6 months Unstable angina New York Heart Association Class III or IV congestive heart failure Severe pulmonary disease Lifer failure Severe dementia Debilitating illness Malignancies, except for nonmelanomatous skin cancer, in the last 5 years
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United States31 sites
VA Stratton Medical Center, Albany
Albany, New York, 12208
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, 48113
VA Medical Center, Birmingham
Birmingham, Alabama, 35233
VA Medical Center, Boise
Boise, Idaho, 83702
New York Harbor Health Care System, Brooklyn
Brooklyn, New York, 11209
VA Western New York Healthcare System at Buffalo
Buffalo, New York, 14215
Jesse Brown VAMC (WestSide Division)
Chicago, Illinois, 60612
VA Medical Center, Clarksburg
Clarksburg, West Virginia, 26301
VA North Texas Health Care System, Dallas
Dallas, Texas, 75216
VA New Jersey Health Care System, East Orange
East Orange, New Jersey, 07018
VA Medical Center, Hampton
Hampton, Virginia, 23667
Richard Roudebush VA Medical Center, Indianapolis
Indianapolis, Indiana, 46202-2884
VA Medical Center, Iowa City
Iowa City, Iowa, 52246-2208
VA Medical Center, Lexington
Lexington, Kentucky, 40502
VA Medical Center, Long Beach
Long Beach, California, 90822
Wlliam S. Middleton Memorial Veterans Hospital, Madison
Madison, Wisconsin, 53705
VA Medical Center, Memphis
Memphis, Tennessee, 38104
Minneapolis VA Health Care System
Minneapolis, Minnesota, 55417
Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
North Little Rock, Arkansas, 72114-1706
VA Medical Center, Oklahoma City
Oklahoma City, Oklahoma, 73104
VA Pittsburgh Health Care System
Pittsburgh, Pennsylvania, 15240
VA Medical Center, Portland
Portland, Oregon, 97201
VA Medical Center, Providence
Providence, Rhode Island, 02908
VA Medical Center, San Francisco
San Francisco, California, 94121
VA Puget Sound Health Care System, Seattle
Seattle, Washington, 98108
VA Greater Los Angeles HCS, Sepulveda
Sepulveda, California, 91343
Overton Brooks VA Medical Center, Shreveport
Shreveport, Louisiana, 71101
VA Medical Center, Syracuse
Syracuse, New York, 13210
James A. Haley Veterans Hospital, Tampa
Tampa, Florida, 33612
Central Texas Veterans Health Care System
Temple, Texas, 76504
VA Medical Center, Bronx
The Bronx, New York, 10468
About this study
Official title: CSP #407 - Prostate Cancer Intervention Versus Observation Trial (PIVOT): A Randomized Trial Comparing Radical Prostatectomy Versus Palliative Expectant Management for the Treatment of Clinically Localized Prostate Cancer
Radical prostatectomy provides potentially curative removal of the cancer. However, it subjects patients to the morbidity and mortality of the surgery and may be neither necessary nor effective. Expectant management does not offer potential cure. However, it provides palliative therapy for symptomatic or metastatic disease progression, avoids potentially excessive and morbid interventions in asymptomatic patients, and emphasizes management approaches for focus on relieving symptoms while minimizing therapeutic complications.
The primary objective of this study is to determine which of two strategies is superior for the management of clinically localized CAP: 1) radical prostatectomy with early aggressive intervention for disease persistence or recurrence, 2) expectant management with reservation of therapy for palliative treatment of symptomatic or metastatic disease progression. Outcomes include total mortality, CAP mortality, disease free and progression free survival, morbidity, quality of life, and cost effectiveness.
Read the detailed description
Primary Hypothesis: To determine whether radical prostatectomy or expectant management is more effective in reducing mortality and extending life.
Secondary Hypothesis: To determine which treatment strategy is superior in terms of prostate specific cancer mortality, quality of life, occurrence or recurrence of symptoms and need for cancer treatment.
Intervention: 1) Radical prostatectomy, plus intervention for evidence of disease persistence or recurrence, 2) Expectant management with palliative therapy reserved for symptomatic or metastatic disease progression.
Primary Outcomes: All cause mortality.
Study Abstract: Cancer of the prostate (CAP) is the most common nondermatologic and the second most frequent cause of cancer deaths in men. No cure is currently possible for disseminated disease. Cancer confined to the prostate is believed to be curable, with the most frequently recommended therapy being surgical extirpation of the tumor with radical prostatectomy. However, despite increasing cancer detection and aggressive surgical treatment, population-based mortality rates from prostate cancer have not decreased, neither nationally nor in states with high rates of radical prostatectomy. Existing evidence does not demonstrate the superiority of this procedure compared to expectant management in the treatment of localized prostate cancer. Data from case series suggest that either treatment approach provides equivalent all-cause as well as prostate cancer specific mortality. The only randomized trial was limited by a small sample size but the results favored expectant management.
Radical prostatectomy provides potentially curative removal of the cancer. However, it subjects patients to the morbidity and mortality of the surgery and may be neither necessary nor effective. Expectant management does not offer potential cure. However, it provides palliative therapy for symptomatic or metastatic disease progression, avoids potentially excessive and morbid interventions in asymptomatic patients, and emphasizes management approaches for focus on relieving symptoms while minimizing therapeutic complications.
The primary objective of this study is to determine which of two strategies is superior for the management of clinically localized CAP: 1) radical prostatectomy with early aggressive intervention for disease persistence or recurrence, 2) expectant management with reservation of therapy for palliative treatment of symptomatic or metastatic disease progression. Outcomes include total mortality, CAP mortality, disease free and progression free survival, morbidity, quality of life, and cost effectiveness.
- Conditions
- Prostate Cancer
- Being tested
- Radical prostatectomy
- Keywords
- cancer of the prostate (CAP), cancer treatment, chronic diseases, expectant management, genitourinary, prostate, prostate specific cancer mortality, radical prostatectomy
- Medical subject headings
- Prostatic Neoplasms, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radical prostatectomyProcedure or surgery
Surgical removal of the prostate
| Study group | Role | What they receive |
|---|---|---|
| Radical Prostatectomy | Other | Surgical removal of the prostate Receives: Procedure: Radical prostatectomy |
| Watchful Waiting | No intervention | Closely watching, waiting and treating symptoms if and when cancer progresses |
What is being measured
The primary outcome is the main question the study is designed to answer.
All Cause Mortality
Number of deaths from any cause.
Measured: From date of randomization until date of death from any cause, assessed until end of study, up to 16 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2001 (estimated)
- Study startNov 1994
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- 731 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Timothy J. Wilt, MD MPH, Study chair, Minneapolis Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00007644
- Sponsor's protocol ID
- 407
- Acronym
- PIVOT
- Status last verified
- Feb 2020
- First submitted
- 29 Dec 2000
- Last updated
- 24 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Wilt T. Expectant management or early intervention for clinically localized prostate cancer? What we need are randomized trials. Clinical Care For Prostatic Diseases. 1994 Jan 6; 1:1-9.
Moon TD, Brawer MK, Wilt TJ. Prostate Intervention Versus Observation Trial (PIVOT): a randomized trial comparing radical prostatectomy with palliative expectant management for treatment of clinically localized prostate cancer. PIVOT Planning Committee. J Natl Cancer Inst Monogr. 1995;(19):69-71. No abstract available.
PubMed 7577210Wilt TJ, Brawer MK. Early intervention or expectant management for prostate cancer. The Prostate Cancer Intervention Versus Observation Trial (PIVOT): a randomized trial comparing radical prostatectomy with expectant management for the treatment of clinically localized prostate cancer. Semin Urol. 1995 May;13(2):130-6. No abstract available.
PubMed 7638470Wilt TJ, Brawer MK. The Prostate Cancer Intervention Versus Observation Trial (PIVOT). Oncology (Williston Park). 1997 Aug;11(8):1133-9; discussion 1139-40, 1143.
PubMed 9268976Wilt T. The importance of randomized treatment trials in early stage prostate cancer. New Developments in Prostate Cancer and Treatment. 1997 Feb 21; 2:29-35.
Wilt TJ. Prostate cancer screening: practice what the evidence preaches. Am J Med. 1998 Jun;104(6):602-4. doi: 10.1016/s0002-9343(98)00127-2. No abstract available.
PubMed 9674725Wilt TJ. Uncertainty in prostate cancer care: the physician's role in clearing the confusion. JAMA. 2000 Jun 28;283(24):3258-60. doi: 10.1001/jama.283.24.3258. No abstract available.
PubMed 10866876Wilt TJ. Prostate carcinoma practice patterns: what do they tell us about the diagnosis, treatment, and outcomes of patients with prostate carcinoma? Cancer. 2000 Mar 15;88(6):1277-81. No abstract available.
PubMed 10717606Wilt T. Editorial comment. Urology. 2001 Nov 1; 58(6):964-965.
Wilt TJ. Clarifying uncertainty regarding detection and treatment of early-stage prostate cancer. Semin Urol Oncol. 2002 Feb;20(1):10-7. doi: 10.1053/suro.2002.30393.
PubMed 11828353Wilt TJ. SPCG-4: a needed START to PIVOTal data to promote and protect evidence-based prostate cancer care. J Natl Cancer Inst. 2008 Aug 20;100(16):1123-5. doi: 10.1093/jnci/djn259. Epub 2008 Aug 11. No abstract available.
PubMed 18695131Kaplan SA, McConnell JD, Roehrborn CG, Meehan AG, Lee MW, Noble WR, Kusek JW, Nyberg LM Jr; Medical Therapy of Prostatic Symptoms (MTOPS) Research Group. Combination therapy with doxazosin and finasteride for benign prostatic hyperplasia in patients with lower urinary tract symptoms and a baseline total prostate volume of 25 ml or greater. J Urol. 2006 Jan;175(1):217-20; discussion 220-1. doi: 10.1016/S0022-5347(05)00041-8.
PubMed 16406915Wilt TJ, Brawer MK, Jones KM, Barry MJ, Aronson WJ, Fox S, Gingrich JR, Wei JT, Gilhooly P, Grob BM, Nsouli I, Iyer P, Cartagena R, Snider G, Roehrborn C, Sharifi R, Blank W, Pandya P, Andriole GL, Culkin D, Wheeler T; Prostate Cancer Intervention versus Observation Trial (PIVOT) Study Group. Radical prostatectomy versus observation for localized prostate cancer. N Engl J Med. 2012 Jul 19;367(3):203-13. doi: 10.1056/NEJMoa1113162.
PubMed 22808955Wilt TJ. Implications of the prostate intervention versus observation trial (PIVOT). Asian J Androl. 2012 Nov;14(6):815. doi: 10.1038/aja.2012.103. Epub 2012 Sep 17. No abstract available.
PubMed 22983306Wilt TJ. The Prostate Cancer Intervention Versus Observation Trial: VA/NCI/AHRQ Cooperative Studies Program #407 (PIVOT): design and baseline results of a randomized controlled trial comparing radical prostatectomy with watchful waiting for men with clinically localized prostate cancer. J Natl Cancer Inst Monogr. 2012 Dec;2012(45):184-90. doi: 10.1093/jncimonographs/lgs041.
PubMed 23271771
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CSP #407 - Prostate Cancer Intervention Versus Observation Trial (PIVOT): A Randomized Trial Comparing Radical Prostatectomy Versus Palliative Expectant Management for the Treatment of Clinically Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT00007644
- Acronym / sponsor ID
- PIVOT / 407
- Conditions
- Prostate Cancer
- Keywords
- cancer of the prostate (CAP), cancer treatment, chronic diseases, expectant management, genitourinary, prostate, prostate specific cancer mortality, radical prostatectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 731 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), National Cancer Institute (NCI)
- Study start
- Nov 1994
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 1 Jan 2001 (estimated)
- Results
- Posted 10 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Radical prostatectomy provides potentially curative removal of the cancer. However, it subjects patients to the morbidity and mortality of the surgery and may be neither necessary nor effective. Expectant management does not offer potential cure. However, it provides palliative therapy for symptomatic or metastatic disease progression, avoids potentially excessive and morbid interventions in asymptomatic patients, and emphasizes management approaches for focus on relieving symptoms while minimizing therapeutic complications.
The primary objective of this study is to determine which of two strategies is superior for the management of clinically localized CAP: 1) radical prostatectomy with early aggressive intervention for disease persistence or recurrence, 2) expectant management with reservation of therapy for palliative treatment of symptomatic or metastatic disease progression. Outcomes include total mortality, CAP mortality, disease free and progression free survival, morbidity, quality of life, and cost effectiveness.
Detailed description
Primary Hypothesis: To determine whether radical prostatectomy or expectant management is more effective in reducing mortality and extending life.
Secondary Hypothesis: To determine which treatment strategy is superior in terms of prostate specific cancer mortality, quality of life, occurrence or recurrence of symptoms and need for cancer treatment.
Intervention: 1) Radical prostatectomy, plus intervention for evidence of disease persistence or recurrence, 2) Expectant management with palliative therapy reserved for symptomatic or metastatic disease progression.
Primary Outcomes: All cause mortality.
Study Abstract: Cancer of the prostate (CAP) is the most common nondermatologic and the second most frequent cause of cancer deaths in men. No cure is currently possible for disseminated disease. Cancer confined to the prostate is believed to be curable, with the most frequently recommended therapy being surgical extirpation of the tumor with radical prostatectomy. However, despite increasing cancer detection and aggressive surgical treatment, population-based mortality rates from prostate cancer have not decreased, neither nationally nor in states with high rates of radical prostatectomy. Existing evidence does not demonstrate the superiority of this procedure compared to expectant management in the treatment of localized prostate cancer. Data from case series suggest that either treatment approach provides equivalent all-cause as well as prostate cancer specific mortality. The only randomized trial was limited by a small sample size but the results favored expectant management.
Radical prostatectomy provides potentially curative removal of the cancer. However, it subjects patients to the morbidity and mortality of the surgery and may be neither necessary nor effective. Expectant management does not offer potential cure. However, it provides palliative therapy for symptomatic or metastatic disease progression, avoids potentially excessive and morbid interventions in asymptomatic patients, and emphasizes management approaches for focus on relieving symptoms while minimizing therapeutic complications.
The primary objective of this study is to determine which of two strategies is superior for the management of clinically localized CAP: 1) radical prostatectomy with early aggressive intervention for disease persistence or recurrence, 2) expectant management with reservation of therapy for palliative treatment of symptomatic or metastatic disease progression. Outcomes include total mortality, CAP mortality, disease free and progression free survival, morbidity, quality of life, and cost effectiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radical Prostatectomy | Other | Procedure: Radical prostatectomySurgical removal of the prostate |
| Watchful Waiting | No intervention | –Closely watching, waiting and treating symptoms if and when cancer progresses |
Who may qualify
- Ages
- Up to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with clinically localized CAP
- Diagnosis of Prostate Cancer within previous 6 months
- Age 75 years or younger
Key exclusion criteria (1 listed)
- PSA > 50 ng/ml Bone scan consistent with metastatic disease Other evidence that cancer of the prostate is not clinically localized Diagnosis of prostate cancer greater than 12 months ago Life expectancy less than 10 years Serum creatinine greater than 3 mg/dl Myocardial infarction within last 6 months Unstable angina New York Heart Association Class III or IV congestive heart failure Severe pulmonary disease Lifer failure Severe dementia Debilitating illness Malignancies, except for nonmelanomatous skin cancer, in the last 5 years
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 |
|---|---|---|
| Radical prostatectomySurgical removal of the prostate | Procedure or surgery | Radical Prostatectomy |
Primary outcome
All Cause Mortality
Time frame: From date of randomization until date of death from any cause, assessed until end of study, up to 16 years
Number of deaths from any cause.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationWilt T. Expectant management or early intervention for clinically localized prostate cancer? What we need are randomized trials. Clinical Care For Prostatic Diseases. 1994 Jan 6; 1:1-9.
- Results publication: PubMed 7577210Moon TD, Brawer MK, Wilt TJ. Prostate Intervention Versus Observation Trial (PIVOT): a randomized trial comparing radical prostatectomy with palliative expectant management for treatment of clinically localized prostate cancer. PIVOT Planning Committee. J Natl Cancer Inst Monogr. 1995;(19):69-71. No abstract available.
- Results publication: PubMed 7638470Wilt TJ, Brawer MK. Early intervention or expectant management for prostate cancer. The Prostate Cancer Intervention Versus Observation Trial (PIVOT): a randomized trial comparing radical prostatectomy with expectant management for the treatment of clinically localized prostate cancer. Semin Urol. 1995 May;13(2):130-6. No abstract available.
- Results publication: PubMed 9268976Wilt TJ, Brawer MK. The Prostate Cancer Intervention Versus Observation Trial (PIVOT). Oncology (Williston Park). 1997 Aug;11(8):1133-9; discussion 1139-40, 1143.
- Results publicationWilt T. The importance of randomized treatment trials in early stage prostate cancer. New Developments in Prostate Cancer and Treatment. 1997 Feb 21; 2:29-35.
- Results publication: PubMed 9674725Wilt TJ. Prostate cancer screening: practice what the evidence preaches. Am J Med. 1998 Jun;104(6):602-4. doi: 10.1016/s0002-9343(98)00127-2. No abstract available.
- Results publication: PubMed 10866876Wilt TJ. Uncertainty in prostate cancer care: the physician's role in clearing the confusion. JAMA. 2000 Jun 28;283(24):3258-60. doi: 10.1001/jama.283.24.3258. No abstract available.
- Results publication: PubMed 10717606Wilt TJ. Prostate carcinoma practice patterns: what do they tell us about the diagnosis, treatment, and outcomes of patients with prostate carcinoma? Cancer. 2000 Mar 15;88(6):1277-81. No abstract available.
- Results publicationWilt T. Editorial comment. Urology. 2001 Nov 1; 58(6):964-965.
- Results publication: PubMed 11828353Wilt TJ. Clarifying uncertainty regarding detection and treatment of early-stage prostate cancer. Semin Urol Oncol. 2002 Feb;20(1):10-7. doi: 10.1053/suro.2002.30393.
- Results publication: PubMed 18695131Wilt TJ. SPCG-4: a needed START to PIVOTal data to promote and protect evidence-based prostate cancer care. J Natl Cancer Inst. 2008 Aug 20;100(16):1123-5. doi: 10.1093/jnci/djn259. Epub 2008 Aug 11. No abstract available.
- Results publication: PubMed 16406915Kaplan SA, McConnell JD, Roehrborn CG, Meehan AG, Lee MW, Noble WR, Kusek JW, Nyberg LM Jr; Medical Therapy of Prostatic Symptoms (MTOPS) Research Group. Combination therapy with doxazosin and finasteride for benign prostatic hyperplasia in patients with lower urinary tract symptoms and a baseline total prostate volume of 25 ml or greater. J Urol. 2006 Jan;175(1):217-20; discussion 220-1. doi: 10.1016/S0022-5347(05)00041-8.
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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.
Timothy J. Wilt, MD MPH study chair
Minneapolis Veterans Affairs Medical Center
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Radical prostatectomy in people with Prostate Cancer, run by VA Office of Research and Development at 31 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 3 inclusion and 1 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 24 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 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.
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?
Yes. Results are posted in the registry (first posted 10 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
All Cause Mortality (time frame: From date of randomization until date of death from any cause, assessed until end of study, up to 16 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00007644, which also lists 19 linked publications.
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 24 Feb 2020.