CancerPHS IINCT00270647
Physicians' Health Study II
A study testing Vitamin E, Vitamin C and Multivitamin in people with Cancer and Prostate Cancer, run by Brigham and Women's Hospital.
Trial summary
The use of vitamin E, vitamin C, beta carotene, and/or multivitamins may keep cancer, cardiovascular disease, eye diseases, or cognitive decline from occurring. This randomized clinical trial studied vitamin E, vitamin C, beta carotene, and/or multivitamins to see how well they work compared with placebos in… Read more about this study
- Who is it for?
- Ages 50 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cancer, Prostate Cancer, Colorectal Cancer
- What is being tested?
- Vitamin E, Vitamin C and Multivitamin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14,641 participants
- Where
- No sites listed yet
- Study dates
- Jul 1997to Jun 2011
- Phase
- Interventional
- 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 50 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- DISEASE CHARACTERISTICS:
- Healthy male physicians practicing in the United States
- Prior participation in the Physicians' Health Study I allowed
- PATIENT CHARACTERISTICS:
- Aged 50 years and over
- No history of serious illness that would preclude study participation
Show all 10Show fewer
- No history of significant adverse events (e.g., rash or allergic reaction) attributed to study agents
- PRIOR CONCURRENT THERAPY:
- No other concurrent vitamin and/or multivitamin supplementation
- No concurrent vitamin K-depleting anticoagulants (e.g., warfarin)
Who cannot join
None listed.
About this study
Official title: Physicians' Health Study II: Trial of Vitamins in the Chemoprevention of Cancer, CVD, and Eye Disease
The use of vitamin E, vitamin C, beta carotene, and/or multivitamins may keep cancer, cardiovascular disease, eye diseases, or cognitive decline from occurring. This randomized clinical trial studied vitamin E, vitamin C, beta carotene, and/or multivitamins to see how well they work compared with placebos in preventing cancer, cardiovascular disease, eye disease, and cognitive decline in male doctors aged 50 years and older.
Read the detailed description
OBJECTIVES:
Primary
- To determine whether vitamin E every other day reduces the risk of developing prostate cancer in older healthy male physicians.
- To determine whether daily vitamin C and/or a multivitamin reduces the risk of total cancer in these participants.
- To determine whether vitamin E every other day, vitamin C daily, or a multivitamin daily reduces the risk of major cardiovascular events in these participants.
Secondary
- To determine whether vitamin E and/or multivitamins reduce the risk of developing total cancer, colon cancer, and colon polyps in these participants.
- To determine whether vitamin E, vitamin C, or multivitamins reduce the risk of myocardial infarction and stroke in these participants.
- To determine whether vitamin E, vitamin C, or multivitamins reduce the risk of age-related macular degeneration or cataract in these participants.
- To determine whether vitamin E, vitamin C, or multivitamins reduce the risk of early cognitive decline in participants aged 65 and over.
The Physicians' Health Study II was a randomized, double-blind, placebo-controlled, factorial trial that began in 1997 and ended in 2011. It was designed to test four supplements -- (1) alternate-day vitamin E (400 international units of synthetic alpha-tocopherol) or its placebo; (2) daily vitamin C (500 mg synthetic ascorbic acid) or its placebo; (3) a daily multivitamin (Centrum Silver) or its placebo; and (4) alternate-day beta carotene (50 mg Lurotin) or its placebo -- in the prevention of cancer, cardiovascular disease, eye disease, and early cognitive decline among 14,641 male physicians aged 50 years or older. Participants were randomly assigned in a 2x2x2x2 factorial trial to receive combinations of the four active supplements or their placebos. Pills and/or packaging were provided by BASF Corporation, Pfizer (formerly Wyeth, American Home Products, and Lederle), and DSM Nutritional Products (formerly Roche Vitamins).
The beta-carotene component was discontinued on March 8, 2003; the vitamin E and vitamin C components ended as scheduled on August 31, 2007; and the multivitamin component ended on June 1, 2011.
- Conditions
- Cancer, Prostate Cancer, Colorectal Cancer, Cardiovascular Disease, Eye Disease, Cognitive Decline
- Being tested
- Vitamin E, Vitamin C, Multivitamin, Beta-carotene
- Keywords
- cancer, prostate cancer, colorectal cancer, cardiovascular disease, eye disease, cognitive decline
- Medical subject headings
- Neoplasms, Prostatic Neoplasms, Colorectal Neoplasms, Cardiovascular Diseases, Eye Diseases, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin EDietary supplement
400 IU synthetic alpha-tocopherol or its placebo on alternate days (provided by BASF)
Vitamin CDietary supplement
500 mg synthetic ascorbic acid or its placebo daily (provided by BASF)
MultivitaminDietary supplement
Centrum Silver or its placebo daily (provided by Pfizer (formerly Wyeth, American Home Products, and Lederle))
Beta-caroteneDietary supplement
50 mg Lurotin or placebo on alternate days (provided by BASF)
| Study group | Role | What they receive |
|---|---|---|
| Vitamin E | Experimental | Active or placebo vitamin E Receives: Dietary Supplement: Vitamin E |
| Vitamin C | Experimental | Active or placebo vitamin C Receives: Dietary Supplement: Vitamin C |
| Multivitamin | Experimental | Active or placebo multivitamin Receives: Dietary Supplement: Multivitamin |
| Beta-carotene | Experimental | Active or placebo beta-carotene Receives: Dietary Supplement: Beta-carotene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prostate cancer
Measured: Ongoing
Total cancer
Measured: Ongoing
Major cardiovascular events
Measured: Ongoing
Secondary outcomes (6)
Cataract
Measured: Ongoing
Age-related macular degeneration
Measured: Ongoing
Early cognitive decline
Measured: Ongoing
Myocardial infarction
Measured: Ongoing
Stroke
Measured: Ongoing
Colorectal cancer
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2005 (estimated)
- Study startJul 1997
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 14,641 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, John Michael Gaziano, MD, Brigham and Women's Hospital
- Investigators
- J. Michael Gaziano, MD, MPH, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00270647
- Sponsor's protocol ID
- CDR0000448630
- Other IDs
- BWH-1999-P-003315, BWH-1999-P-003318, BWH-83-00405, R01CA097193
- Acronym
- PHS II
- Status last verified
- Feb 2018
- First submitted
- 27 Dec 2005
- Last updated
- 28 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Christen WG, Gaziano JM, Hennekens CH. Design of Physicians' Health Study II--a randomized trial of beta-carotene, vitamins E and C, and multivitamins, in prevention of cancer, cardiovascular disease, and eye disease, and review of results of completed trials. Ann Epidemiol. 2000 Feb;10(2):125-34. doi: 10.1016/s1047-2797(99)00042-3.
PubMed 10691066Gaziano JM, Glynn RJ, Christen WG, Kurth T, Belanger C, MacFadyen J, Bubes V, Manson JE, Sesso HD, Buring JE. Vitamins E and C in the prevention of prostate and total cancer in men: the Physicians' Health Study II randomized controlled trial. JAMA. 2009 Jan 7;301(1):52-62. doi: 10.1001/jama.2008.862. Epub 2008 Dec 9.
PubMed 19066368Sesso HD, Buring JE, Christen WG, Kurth T, Belanger C, MacFadyen J, Bubes V, Manson JE, Glynn RJ, Gaziano JM. Vitamins E and C in the prevention of cardiovascular disease in men: the Physicians' Health Study II randomized controlled trial. JAMA. 2008 Nov 12;300(18):2123-33. doi: 10.1001/jama.2008.600. Epub 2008 Nov 9.
PubMed 18997197Christen WG, Glynn RJ, Sesso HD, Kurth T, Macfadyen J, Bubes V, Buring JE, Manson JE, Gaziano JM. Vitamins E and C and medical record-confirmed age-related macular degeneration in a randomized trial of male physicians. Ophthalmology. 2012 Aug;119(8):1642-9. doi: 10.1016/j.ophtha.2012.01.053. Epub 2012 Apr 13.
PubMed 22503302Christen WG, Glynn RJ, Sesso HD, Kurth T, MacFadyen J, Bubes V, Buring JE, Manson JE, Gaziano JM. Age-related cataract in a randomized trial of vitamins E and C in men. Arch Ophthalmol. 2010 Nov;128(11):1397-405. doi: 10.1001/archophthalmol.2010.266.
PubMed 21060040Grodstein F, Kang JH, Glynn RJ, Cook NR, Gaziano JM. A randomized trial of beta carotene supplementation and cognitive function in men: the Physicians' Health Study II. Arch Intern Med. 2007 Nov 12;167(20):2184-90. doi: 10.1001/archinte.167.20.2184.
PubMed 17998490Juraschek SP, Gaziano JM, Glynn RJ, Gomelskaya N, Bubes VY, Buring JE, Shmerling RH, Sesso HD. Effects of vitamin C supplementation on gout risk: results from the Physicians' Health Study II trial. Am J Clin Nutr. 2022 Sep 2;116(3):812-819. doi: 10.1093/ajcn/nqac140.
PubMed 35575611Rautiainen S, Gaziano JM, Christen WG, Bubes V, Kotler G, Glynn RJ, Manson JE, Buring JE, Sesso HD. Effect of Baseline Nutritional Status on Long-term Multivitamin Use and Cardiovascular Disease Risk: A Secondary Analysis of the Physicians' Health Study II Randomized Clinical Trial. JAMA Cardiol. 2017 Jun 1;2(6):617-625. doi: 10.1001/jamacardio.2017.0176.
PubMed 28384735Wang L, Sesso HD, Glynn RJ, Christen WG, Bubes V, Manson JE, Buring JE, Gaziano JM. Vitamin E and C supplementation and risk of cancer in men: posttrial follow-up in the Physicians' Health Study II randomized trial. Am J Clin Nutr. 2014 Sep;100(3):915-23. doi: 10.3945/ajcn.114.085480. Epub 2014 Jul 9.
PubMed 25008853Grodstein F, O'Brien J, Kang JH, Dushkes R, Cook NR, Okereke O, Manson JE, Glynn RJ, Buring JE, Gaziano M, Sesso HD. Long-term multivitamin supplementation and cognitive function in men: a randomized trial. Ann Intern Med. 2013 Dec 17;159(12):806-14. doi: 10.7326/0003-4819-159-12-201312170-00006.
PubMed 24490265Christen WG, Glynn RJ, Manson JE, MacFadyen J, Bubes V, Schvartz M, Buring JE, Sesso HD, Gaziano JM. Effects of multivitamin supplement on cataract and age-related macular degeneration in a randomized trial of male physicians. Ophthalmology. 2014 Feb;121(2):525-34. doi: 10.1016/j.ophtha.2013.09.038. Epub 2013 Nov 20.
PubMed 24268861Gaziano JM, Sesso HD, Christen WG, Bubes V, Smith JP, MacFadyen J, Schvartz M, Manson JE, Glynn RJ, Buring JE. Multivitamins in the prevention of cancer in men: the Physicians' Health Study II randomized controlled trial. JAMA. 2012 Nov 14;308(18):1871-80. doi: 10.1001/jama.2012.14641.
PubMed 23162860Sesso HD, Christen WG, Bubes V, Smith JP, MacFadyen J, Schvartz M, Manson JE, Glynn RJ, Buring JE, Gaziano JM. Multivitamins in the prevention of cardiovascular disease in men: the Physicians' Health Study II randomized controlled trial. JAMA. 2012 Nov 7;308(17):1751-60. doi: 10.1001/jama.2012.14805.
PubMed 23117775
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physicians' Health Study II: Trial of Vitamins in the Chemoprevention of Cancer, CVD, and Eye Disease
- ClinicalTrials.gov ID
- NCT00270647
- Acronym / sponsor ID
- PHS II / CDR0000448630
- Conditions
- Cancer, Prostate Cancer, Colorectal Cancer, Cardiovascular Disease, Eye Disease, Cognitive Decline
- Keywords
- cancer, prostate cancer, colorectal cancer, cardiovascular disease, eye disease, cognitive decline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14,641 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 1997
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 28 Dec 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.
The use of vitamin E, vitamin C, beta carotene, and/or multivitamins may keep cancer, cardiovascular disease, eye diseases, or cognitive decline from occurring. This randomized clinical trial studied vitamin E, vitamin C, beta carotene, and/or multivitamins to see how well they work compared with placebos in preventing cancer, cardiovascular disease, eye disease, and cognitive decline in male doctors aged 50 years and older.
Detailed description
OBJECTIVES:
Primary
- To determine whether vitamin E every other day reduces the risk of developing prostate cancer in older healthy male physicians.
- To determine whether daily vitamin C and/or a multivitamin reduces the risk of total cancer in these participants.
- To determine whether vitamin E every other day, vitamin C daily, or a multivitamin daily reduces the risk of major cardiovascular events in these participants.
Secondary
- To determine whether vitamin E and/or multivitamins reduce the risk of developing total cancer, colon cancer, and colon polyps in these participants.
- To determine whether vitamin E, vitamin C, or multivitamins reduce the risk of myocardial infarction and stroke in these participants.
- To determine whether vitamin E, vitamin C, or multivitamins reduce the risk of age-related macular degeneration or cataract in these participants.
- To determine whether vitamin E, vitamin C, or multivitamins reduce the risk of early cognitive decline in participants aged 65 and over.
The Physicians' Health Study II was a randomized, double-blind, placebo-controlled, factorial trial that began in 1997 and ended in 2011. It was designed to test four supplements -- (1) alternate-day vitamin E (400 international units of synthetic alpha-tocopherol) or its placebo; (2) daily vitamin C (500 mg synthetic ascorbic acid) or its placebo; (3) a daily multivitamin (Centrum Silver) or its placebo; and (4) alternate-day beta carotene (50 mg Lurotin) or its placebo -- in the prevention of cancer, cardiovascular disease, eye disease, and early cognitive decline among 14,641 male physicians aged 50 years or older. Participants were randomly assigned in a 2x2x2x2 factorial trial to receive combinations of the four active supplements or their placebos. Pills and/or packaging were provided by BASF Corporation, Pfizer (formerly Wyeth, American Home Products, and Lederle), and DSM Nutritional Products (formerly Roche Vitamins).
The beta-carotene component was discontinued on March 8, 2003; the vitamin E and vitamin C components ended as scheduled on August 31, 2007; and the multivitamin component ended on June 1, 2011.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Vitamin E | Experimental | Dietary Supplement: Vitamin EActive or placebo vitamin E |
| Vitamin C | Experimental | Dietary Supplement: Vitamin CActive or placebo vitamin C |
| Multivitamin | Experimental | Dietary Supplement: MultivitaminActive or placebo multivitamin |
| Beta-carotene | Experimental | Dietary Supplement: Beta-caroteneActive or placebo beta-carotene |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- DISEASE CHARACTERISTICS:
- PATIENT CHARACTERISTICS:
- PRIOR CONCURRENT THERAPY:
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Vitamin E400 IU synthetic alpha-tocopherol or its placebo on alternate days (provided by BASF) | Dietary supplement | Vitamin E |
| Vitamin C500 mg synthetic ascorbic acid or its placebo daily (provided by BASF) | Dietary supplement | Vitamin C |
| MultivitaminCentrum Silver or its placebo daily (provided by Pfizer (formerly Wyeth, American Home Products, and Lederle)) | Dietary supplement | Multivitamin |
| Beta-carotene50 mg Lurotin or placebo on alternate days (provided by BASF) | Dietary supplement | Beta-carotene |
Primary outcome
Prostate cancer
Time frame: Ongoing
Total cancer
Time frame: Ongoing
Major cardiovascular events
Time frame: Ongoing
6 secondary outcomes
Cataract
Time frame: Ongoing
Age-related macular degeneration
Time frame: Ongoing
Early cognitive decline
Time frame: Ongoing
Myocardial infarction
Time frame: Ongoing
Stroke
Time frame: Ongoing
Colorectal cancer
Time frame: Ongoing
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 28 Feb 2018.
- Background: PubMed 10691066Christen WG, Gaziano JM, Hennekens CH. Design of Physicians' Health Study II--a randomized trial of beta-carotene, vitamins E and C, and multivitamins, in prevention of cancer, cardiovascular disease, and eye disease, and review of results of completed trials. Ann Epidemiol. 2000 Feb;10(2):125-34. doi: 10.1016/s1047-2797(99)00042-3.
- Results publication: PubMed 19066368Gaziano JM, Glynn RJ, Christen WG, Kurth T, Belanger C, MacFadyen J, Bubes V, Manson JE, Sesso HD, Buring JE. Vitamins E and C in the prevention of prostate and total cancer in men: the Physicians' Health Study II randomized controlled trial. JAMA. 2009 Jan 7;301(1):52-62. doi: 10.1001/jama.2008.862. Epub 2008 Dec 9.
- Results publication: PubMed 18997197Sesso HD, Buring JE, Christen WG, Kurth T, Belanger C, MacFadyen J, Bubes V, Manson JE, Glynn RJ, Gaziano JM. Vitamins E and C in the prevention of cardiovascular disease in men: the Physicians' Health Study II randomized controlled trial. JAMA. 2008 Nov 12;300(18):2123-33. doi: 10.1001/jama.2008.600. Epub 2008 Nov 9.
- Results publication: PubMed 22503302Christen WG, Glynn RJ, Sesso HD, Kurth T, Macfadyen J, Bubes V, Buring JE, Manson JE, Gaziano JM. Vitamins E and C and medical record-confirmed age-related macular degeneration in a randomized trial of male physicians. Ophthalmology. 2012 Aug;119(8):1642-9. doi: 10.1016/j.ophtha.2012.01.053. Epub 2012 Apr 13.
- Results publication: PubMed 21060040Christen WG, Glynn RJ, Sesso HD, Kurth T, MacFadyen J, Bubes V, Buring JE, Manson JE, Gaziano JM. Age-related cataract in a randomized trial of vitamins E and C in men. Arch Ophthalmol. 2010 Nov;128(11):1397-405. doi: 10.1001/archophthalmol.2010.266.
- Results publication: PubMed 17998490Grodstein F, Kang JH, Glynn RJ, Cook NR, Gaziano JM. A randomized trial of beta carotene supplementation and cognitive function in men: the Physicians' Health Study II. Arch Intern Med. 2007 Nov 12;167(20):2184-90. doi: 10.1001/archinte.167.20.2184.
- Derived from this study: PubMed 35575611Juraschek SP, Gaziano JM, Glynn RJ, Gomelskaya N, Bubes VY, Buring JE, Shmerling RH, Sesso HD. Effects of vitamin C supplementation on gout risk: results from the Physicians' Health Study II trial. Am J Clin Nutr. 2022 Sep 2;116(3):812-819. doi: 10.1093/ajcn/nqac140.
- Derived from this study: PubMed 28384735Rautiainen S, Gaziano JM, Christen WG, Bubes V, Kotler G, Glynn RJ, Manson JE, Buring JE, Sesso HD. Effect of Baseline Nutritional Status on Long-term Multivitamin Use and Cardiovascular Disease Risk: A Secondary Analysis of the Physicians' Health Study II Randomized Clinical Trial. JAMA Cardiol. 2017 Jun 1;2(6):617-625. doi: 10.1001/jamacardio.2017.0176.
- Derived from this study: PubMed 25008853Wang L, Sesso HD, Glynn RJ, Christen WG, Bubes V, Manson JE, Buring JE, Gaziano JM. Vitamin E and C supplementation and risk of cancer in men: posttrial follow-up in the Physicians' Health Study II randomized trial. Am J Clin Nutr. 2014 Sep;100(3):915-23. doi: 10.3945/ajcn.114.085480. Epub 2014 Jul 9.
- Derived from this study: PubMed 24490265Grodstein F, O'Brien J, Kang JH, Dushkes R, Cook NR, Okereke O, Manson JE, Glynn RJ, Buring JE, Gaziano M, Sesso HD. Long-term multivitamin supplementation and cognitive function in men: a randomized trial. Ann Intern Med. 2013 Dec 17;159(12):806-14. doi: 10.7326/0003-4819-159-12-201312170-00006.
- Derived from this study: PubMed 24268861Christen WG, Glynn RJ, Manson JE, MacFadyen J, Bubes V, Schvartz M, Buring JE, Sesso HD, Gaziano JM. Effects of multivitamin supplement on cataract and age-related macular degeneration in a randomized trial of male physicians. Ophthalmology. 2014 Feb;121(2):525-34. doi: 10.1016/j.ophtha.2013.09.038. Epub 2013 Nov 20.
- Derived from this study: PubMed 23162860Gaziano JM, Sesso HD, Christen WG, Bubes V, Smith JP, MacFadyen J, Schvartz M, Manson JE, Glynn RJ, Buring JE. Multivitamins in the prevention of cancer in men: the Physicians' Health Study II randomized controlled trial. JAMA. 2012 Nov 14;308(18):1871-80. doi: 10.1001/jama.2012.14641.
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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.
J. Michael Gaziano, MD, MPH principal investigator
Brigham and Women's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin E, Vitamin C and Multivitamin in people with Cancer and Prostate Cancer, run by Brigham and Women's Hospital.
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 10 inclusion and 0 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 28 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Prostate cancer (time frame: Ongoing). The study lists 3 primary outcomes in all. 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 NCT00270647, which also lists 13 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 28 Feb 2018; AzTrials last refreshed its copy on 27 Oct 2026.