Precancerous/Nonmalignant ConditionPhase 3NCT00030901
S9917, Selenium in Preventing Cancer in Patients With Neoplasia of the Prostate
A Phase 3 study testing L-selenomethionine in people with Precancerous/Nonmalignant Condition and Prostate Cancer, run by SWOG Cancer Research Network.
Trial summary
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. The use of selenium may be an effective way to prevent prostate cancer in patients who have neoplasia of the prostate. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Precancerous/Nonmalignant Condition, Prostate Cancer
- What is being tested?
- L-selenomethionine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 619 participants
- Where
- No sites listed yet
- Study dates
- Feb 2000to Nov 2011
- 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 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of high-grade prostatic intraepithelial neoplasia with no evidence of cancer
- Documented by a digital rectal exam and biopsy of the prostate with transrectal ultrasound guidance (required if fewer than 6 cores obtained in biopsy) meeting one of the following conditions:
- Biopsy yielded fewer than 10 cores within the past 24 months OR yielded more than 10 cores 6-24 months before study
- Biopsy yielded 10 or more cores within the past 6 months
- PSA ≤ 10 ng/mL (≤ 5 ng/mL for patients who have received finasteride or other androgen suppressor within the past 2 months)
- American Urological Association symptom score of less than 20
PATIENT CHARACTERISTICS:
Age:
- 40 and over
Performance status:
- SWOG 0-1
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- No malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or adequately treated stage I or II cancer that is in complete remission
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- See Disease Characteristics
- No concurrent finasteride or any other androgen suppressor
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- At least 30 days since prior daily dietary supplements containing 50 micrograms or more of selenium
- No concurrent daily dietary supplements containing more than 50 micrograms of selenium
About this study
Official title: L-Selenium-Based Chemoprevention Of Prostate Cancer Among Men With High Grade Prostatic Intraepithelial Neoplasia
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. The use of selenium may be an effective way to prevent prostate cancer in patients who have neoplasia of the prostate.
PURPOSE: Randomized phase III trial to study the effectiveness of selenium in preventing prostate cancer in patients who have neoplasia of the prostate.
Read the detailed description
OBJECTIVES:
- Compare the effects of selenium versus placebo on the 3-year incidence rate of prostate cancer in patients with high-grade prostatic intraepithelial neoplasia.
- Compare the toxicity of these regimens in these patients.
- Compare the effects of these regimens on the rate of increase in prostate-specific antigen (PSA) in these patients.
- Compare the effects of these regimens on prostatic cellular proliferation and apoptosis, degradation of basal cell integrity of prostatic ducts, and changes in nuclear chromatin patterns in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to age (40-60 vs 61 and over), race (African American vs other), baseline PSA (less than 4 ng/mL vs 4-10 ng/mL), concurrent vitamin E supplementation (yes vs no), and cores obtained from initial biopsy (10 or more vs less than 10). Patients are randomized to 1 of 2 arms.
- Arm I: Patients receive oral selenium once daily.
- Arm II: Patients receive oral placebo once daily. Treatment in both arms continues for 3 years in the absence of progression to prostate cancer or unacceptable toxicity.
Patients are followed every 6 months for 2 years and then annually for 8 years.
PROJECTED ACCRUAL: A total of 465 patients will be randomized for this study.
- Being tested
- L-selenomethionine, L-selenomethionine placebo
- Keywords
- prostate cancer, high grade prostatic intraepithelial neoplasia
- Medical subject headings
- Precancerous Conditions, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-selenomethionineDrug
Also called Selenium
Randomization between active L-selenomethionine and placebo
L-selenomethionine placeboDrug
Also called placebo
Randomization between active L-selenomethionine and placebo
| Study group | Role | What they receive |
|---|---|---|
| L-selenomethionine | Active comparator | L-selenomethionine (Selenium)one tablet by mouth daily for 3 years. Receives: Drug: L-selenomethionine |
| L-selenomethionine placebo | Placebo comparator | L-selenomethionine placebo one tablet by mouth daily for 3 years Receives: Drug: L-selenomethionine placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Carcinoma of the Prostate as Measured by Biopsy
The primary endpoint is biopsy-proven presence/absence of carcinoma of the prostate within 3 years after randomization to treatment. An end-of-study biopsy at 3 years after randomization will be used to determine presence/absence of prostate carcinoma in those patients not previously diagnosed with prostate carcinoma on study. Biopsies performed within ± 90 days of the 3-year anniversary will be considered end-of-study biopsies. Pathologically confirmed presence of prostate carcinoma may be determined at any time during the 3 years and 90 days after randomization, but absence can only be determined by the end-of-study biopsy.
Measured: 3 years
Secondary outcomes (1)
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 2.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
Measured: 3 months after randomization and then every 3 months for 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startFeb 2000
- Primary completionNov 2011
- Study completionNov 2011
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 (2)Papers the sponsor has linked to this study.
- Other trials for Precancerous/Nonmalignant ConditionStudies of the same condition, open and under way.
- More trials run by SWOG Cancer Research NetworkThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 619 participants (actual)
Sponsor and investigators
- Lead sponsor
- SWOG Cancer Research Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI), Eastern Cooperative Oncology Group, Cancer and Leukemia Group B
- Responsible party
- Sponsor
- Investigators
- Jim Marshall, PhD, Study chair, Roswell Park Cancer InstituteDavid Jarrard, MD, Study chair, University of Wisconsin, MadisonW. Robert Lee, MD, Study chair, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00030901
- Sponsor's protocol ID
- CDR0000069210
- Other IDs
- U10CA037429, S9917, CALGB-70004, NCI-P02-0203
- Status last verified
- Jan 2013
- First submitted
- 14 Feb 2002
- Last updated
- 6 Feb 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Marshall JR, Sakr W, Wood D, Berry D, Tangen C, Parker F, Thompson I, Lippman SM, Lieberman R, Alberts D, Jarrard D, Coltman C, Greenwald P, Minasian L, Crawford ED. Design and progress of a trial of selenium to prevent prostate cancer among men with high-grade prostatic intraepithelial neoplasia. Cancer Epidemiol Biomarkers Prev. 2006 Aug;15(8):1479-84. doi: 10.1158/1055-9965.EPI-05-0585.
PubMed 16896036Sakr WA, Faulkner JR, Wood D: Low rate of confirming prostate cancer on repeat biopsies following diagnosis of high grade prostatic intraepithelial neoplasia: preliminary analysis of Southwest Oncology Group study s9917. [Abstract] Proceedings of the American Association for Cancer Research 45: A-1333, 305, 2004.
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- L-Selenium-Based Chemoprevention Of Prostate Cancer Among Men With High Grade Prostatic Intraepithelial Neoplasia
- ClinicalTrials.gov ID
- NCT00030901
- Acronym / sponsor ID
- CDR0000069210
- Keywords
- prostate cancer, high grade prostatic intraepithelial neoplasia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 619 participants (actual)
- Lead sponsor
- SWOG Cancer Research NetworkResearch network
- Collaborators
- National Cancer Institute (NCI), Eastern Cooperative Oncology Group, Cancer and Leukemia Group B
- Study start
- Feb 2000
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Posted 6 Feb 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. The use of selenium may be an effective way to prevent prostate cancer in patients who have neoplasia of the prostate.
PURPOSE: Randomized phase III trial to study the effectiveness of selenium in preventing prostate cancer in patients who have neoplasia of the prostate.
Detailed description
OBJECTIVES:
- Compare the effects of selenium versus placebo on the 3-year incidence rate of prostate cancer in patients with high-grade prostatic intraepithelial neoplasia.
- Compare the toxicity of these regimens in these patients.
- Compare the effects of these regimens on the rate of increase in prostate-specific antigen (PSA) in these patients.
- Compare the effects of these regimens on prostatic cellular proliferation and apoptosis, degradation of basal cell integrity of prostatic ducts, and changes in nuclear chromatin patterns in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to age (40-60 vs 61 and over), race (African American vs other), baseline PSA (less than 4 ng/mL vs 4-10 ng/mL), concurrent vitamin E supplementation (yes vs no), and cores obtained from initial biopsy (10 or more vs less than 10). Patients are randomized to 1 of 2 arms.
- Arm I: Patients receive oral selenium once daily.
- Arm II: Patients receive oral placebo once daily. Treatment in both arms continues for 3 years in the absence of progression to prostate cancer or unacceptable toxicity.
Patients are followed every 6 months for 2 years and then annually for 8 years.
PROJECTED ACCRUAL: A total of 465 patients will be randomized for this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L-selenomethionine | Active comparator | Drug: L-selenomethionineL-selenomethionine (Selenium)one tablet by mouth daily for 3 years. |
| L-selenomethionine placebo | Placebo comparator | Drug: L-selenomethionine placeboL-selenomethionine placebo one tablet by mouth daily for 3 years |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| L-selenomethionineAlso: SeleniumRandomization between active L-selenomethionine and placebo | Drug | L-selenomethionine |
| L-selenomethionine placeboAlso: placeboRandomization between active L-selenomethionine and placebo | Drug | L-selenomethionine placebo |
Primary outcome
Presence of Carcinoma of the Prostate as Measured by Biopsy
Time frame: 3 years
The primary endpoint is biopsy-proven presence/absence of carcinoma of the prostate within 3 years after randomization to treatment. An end-of-study biopsy at 3 years after randomization will be used to determine presence/absence of prostate carcinoma in those patients not previously diagnosed with prostate carcinoma on study. Biopsies performed within ± 90 days of the 3-year anniversary will be considered end-of-study biopsies. Pathologically confirmed presence of prostate carcinoma may be determined at any time during the 3 years and 90 days after randomization, but absence can only be determined by the end-of-study biopsy.
1 secondary outcome
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Time frame: 3 months after randomization and then every 3 months for 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 16896036Marshall JR, Sakr W, Wood D, Berry D, Tangen C, Parker F, Thompson I, Lippman SM, Lieberman R, Alberts D, Jarrard D, Coltman C, Greenwald P, Minasian L, Crawford ED. Design and progress of a trial of selenium to prevent prostate cancer among men with high-grade prostatic intraepithelial neoplasia. Cancer Epidemiol Biomarkers Prev. 2006 Aug;15(8):1479-84. doi: 10.1158/1055-9965.EPI-05-0585.
- Results publicationSakr WA, Faulkner JR, Wood D: Low rate of confirming prostate cancer on repeat biopsies following diagnosis of high grade prostatic intraepithelial neoplasia: preliminary analysis of Southwest Oncology Group study s9917. [Abstract] Proceedings of the American Association for Cancer Research 45: A-1333, 305, 2004.
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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.
Jim Marshall, PhD study chair
Roswell Park Cancer Institute
David Jarrard, MD study chair
University of Wisconsin, Madison
W. Robert Lee, MD study chair
Wake Forest University Health Sciences
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing L-selenomethionine in people with Precancerous/Nonmalignant Condition and Prostate Cancer, run by SWOG Cancer Research Network.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 6 Feb 2013. 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. Some participants in this study may receive a placebo. 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 6 Feb 2013). 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?
Presence of Carcinoma of the Prostate as Measured by Biopsy (time frame: 3 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 NCT00030901, which also lists 2 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 6 Feb 2013.