Trial Outcomes & Findings for S9917, Selenium in Preventing Cancer in Patients With Neoplasia of the Prostate (NCT NCT00030901)
NCT ID: NCT00030901
Last Updated: 2013-02-06
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
619 participants
Primary outcome timeframe
3 years
Results posted on
2013-02-06
Participant Flow
Participant milestones
| Measure |
All Patients
|
Selenium
Patients receive oral selenium once daily for 3 years
|
Placebo
Patients receive oral placebo once daily for 3 years
|
|---|---|---|---|
|
Initial Registration
STARTED
|
619
|
0
|
0
|
|
Initial Registration
COMPLETED
|
452
|
0
|
0
|
|
Initial Registration
NOT COMPLETED
|
167
|
0
|
0
|
|
Randomization
STARTED
|
0
|
227
|
225
|
|
Randomization
Eligible
|
0
|
212
|
211
|
|
Randomization
COMPLETED
|
0
|
126
|
137
|
|
Randomization
NOT COMPLETED
|
0
|
101
|
88
|
Reasons for withdrawal
| Measure |
All Patients
|
Selenium
Patients receive oral selenium once daily for 3 years
|
Placebo
Patients receive oral placebo once daily for 3 years
|
|---|---|---|---|
|
Initial Registration
Ineligible
|
167
|
0
|
0
|
|
Randomization
Adverse Event
|
0
|
11
|
7
|
|
Randomization
Refusal Unrelated to Adverse Event
|
0
|
16
|
10
|
|
Randomization
Progression/Relapse
|
0
|
22
|
21
|
|
Randomization
Death
|
0
|
1
|
3
|
|
Randomization
Other
|
0
|
36
|
33
|
|
Randomization
Ineligible
|
0
|
15
|
14
|
Baseline Characteristics
S9917, Selenium in Preventing Cancer in Patients With Neoplasia of the Prostate
Baseline characteristics by cohort
| Measure |
Selenium
n=212 Participants
Patients receive oral selenium once daily for 3 years
|
Placebo
n=211 Participants
Patients receive oral placebo once daily for 3 years
|
Total
n=423 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
65.90 years
n=5 Participants
|
65.30 years
n=7 Participants
|
65.65 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
212 Participants
n=5 Participants
|
211 Participants
n=7 Participants
|
423 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
195 Participants
n=5 Participants
|
187 Participants
n=7 Participants
|
382 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
26 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
180 Participants
n=5 Participants
|
173 Participants
n=7 Participants
|
353 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age
<50 years
|
9 participants
n=5 Participants
|
7 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Age
50-54 years
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Age
55-60 years
|
28 participants
n=5 Participants
|
35 participants
n=7 Participants
|
63 participants
n=5 Participants
|
|
Age
61-70 years
|
96 participants
n=5 Participants
|
98 participants
n=7 Participants
|
194 participants
n=5 Participants
|
|
Age
>70 years
|
59 participants
n=5 Participants
|
51 participants
n=7 Participants
|
110 participants
n=5 Participants
|
|
Baseline Prostate-Specific Antigen (PSA) - reported by site
<4 ng/mL
|
81 participants
n=5 Participants
|
90 participants
n=7 Participants
|
171 participants
n=5 Participants
|
|
Baseline Prostate-Specific Antigen (PSA) - reported by site
4-10 ng/mL
|
131 participants
n=5 Participants
|
121 participants
n=7 Participants
|
252 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: All eligible randomized patients who started treatment and have prostate cancer known through an interim biopsy or a biopsy taken at +/- 90 days of the end of study were included in the analysis.
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.
Outcome measures
| Measure |
Selenium
n=135 Participants
Patients receive oral selenium once daily for 3 years
|
Placebo
n=134 Participants
Patients receive oral placebo once daily for 3 years
|
|---|---|---|
|
Presence of Carcinoma of the Prostate as Measured by Biopsy
|
48 participants
|
49 participants
|
SECONDARY outcome
Timeframe: 3 months after randomization and then every 3 months for 3 yearsPopulation: Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.
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.
Outcome measures
| Measure |
Selenium
n=203 Participants
Patients receive oral selenium once daily for 3 years
|
Placebo
n=202 Participants
Patients receive oral placebo once daily for 3 years
|
|---|---|---|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Cardiac ischemia/infarction
|
0 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
GI-other
|
0 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Rash/desquamation
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Urinary frequency/urgency
|
0 Participants
|
1 Participants
|
Adverse Events
Selenium
Serious events: 9 serious events
Other events: 54 other events
Deaths: 0 deaths
Placebo
Serious events: 4 serious events
Other events: 57 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Selenium
n=203 participants at risk
Patients receive oral selenium once daily for 3 years
|
Placebo
n=202 participants at risk
Patients receive oral placebo once daily for 3 years
|
|---|---|---|
|
Cardiac disorders
Cardiac ischemia/infarction
|
0.99%
2/203 • 3 months after randomization and then every 3 months for 3 years
|
0.50%
1/202 • 3 months after randomization and then every 3 months for 3 years
|
|
Cardiac disorders
Cardiovascular-other
|
0.99%
2/203 • 3 months after randomization and then every 3 months for 3 years
|
0.50%
1/202 • 3 months after randomization and then every 3 months for 3 years
|
|
Cardiac disorders
LVEF decrease/CHF
|
0.49%
1/203 • 3 months after randomization and then every 3 months for 3 years
|
0.00%
0/202 • 3 months after randomization and then every 3 months for 3 years
|
|
Cardiac disorders
Supraventricular arrhythmia
|
0.49%
1/203 • 3 months after randomization and then every 3 months for 3 years
|
0.00%
0/202 • 3 months after randomization and then every 3 months for 3 years
|
|
Gastrointestinal disorders
Abdominal pain/cramping
|
0.49%
1/203 • 3 months after randomization and then every 3 months for 3 years
|
0.00%
0/202 • 3 months after randomization and then every 3 months for 3 years
|
|
Gastrointestinal disorders
GI-other
|
0.49%
1/203 • 3 months after randomization and then every 3 months for 3 years
|
0.00%
0/202 • 3 months after randomization and then every 3 months for 3 years
|
|
General disorders
Reportable adverse event, NOS
|
0.00%
0/203 • 3 months after randomization and then every 3 months for 3 years
|
0.50%
1/202 • 3 months after randomization and then every 3 months for 3 years
|
|
Nervous system disorders
Cerebrovascular ischemia
|
0.49%
1/203 • 3 months after randomization and then every 3 months for 3 years
|
0.00%
0/202 • 3 months after randomization and then every 3 months for 3 years
|
|
Nervous system disorders
Neuro-other
|
0.49%
1/203 • 3 months after randomization and then every 3 months for 3 years
|
0.00%
0/202 • 3 months after randomization and then every 3 months for 3 years
|
|
Renal and urinary disorders
Renal failure
|
0.49%
1/203 • 3 months after randomization and then every 3 months for 3 years
|
0.00%
0/202 • 3 months after randomization and then every 3 months for 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.49%
1/203 • 3 months after randomization and then every 3 months for 3 years
|
0.00%
0/202 • 3 months after randomization and then every 3 months for 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusions
|
0.49%
1/203 • 3 months after randomization and then every 3 months for 3 years
|
0.00%
0/202 • 3 months after randomization and then every 3 months for 3 years
|
|
Vascular disorders
Thrombosis/embolism
|
0.49%
1/203 • 3 months after randomization and then every 3 months for 3 years
|
0.50%
1/202 • 3 months after randomization and then every 3 months for 3 years
|
Other adverse events
| Measure |
Selenium
n=203 participants at risk
Patients receive oral selenium once daily for 3 years
|
Placebo
n=202 participants at risk
Patients receive oral placebo once daily for 3 years
|
|---|---|---|
|
Gastrointestinal disorders
GI-other
|
6.4%
13/203 • 3 months after randomization and then every 3 months for 3 years
|
5.4%
11/202 • 3 months after randomization and then every 3 months for 3 years
|
|
General disorders
Fatigue/malaise/lethargy
|
13.8%
28/203 • 3 months after randomization and then every 3 months for 3 years
|
8.9%
18/202 • 3 months after randomization and then every 3 months for 3 years
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
8.4%
17/203 • 3 months after randomization and then every 3 months for 3 years
|
11.4%
23/202 • 3 months after randomization and then every 3 months for 3 years
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
7.9%
16/203 • 3 months after randomization and then every 3 months for 3 years
|
5.4%
11/202 • 3 months after randomization and then every 3 months for 3 years
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
0.00%
0/203 • 3 months after randomization and then every 3 months for 3 years
|
5.4%
11/202 • 3 months after randomization and then every 3 months for 3 years
|
Additional Information
Study Statistician
SWOG Statistical Center
Phone: 206-667-4623
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place