Trial Outcomes & Findings for Selenomethionine and Finasteride Before Surgery or Radiation Therapy in Treating Patients With Stage I or Stage II Prostate Cancer (NCT NCT00736645)
NCT ID: NCT00736645
Last Updated: 2023-10-02
Results Overview
Compare PSA levels with Finasteride Placebo + Selenium Placebo group (Arm C). The Wilcoxon Rank Sum Test was used to test the difference of PSA levels of Arm A, Arm B, Arm D with Arm C.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
55 participants
Primary outcome timeframe
1 year
Results posted on
2023-10-02
Participant Flow
Participant milestones
| Measure |
Arm A: Finasteride + Selenium Placebo
Patients receive oral placebo and oral finasteride once daily for 4-5 weeks.
Finasteride: Given orally
Placebo: Given orally
|
Arm B: Finasteride + Selenium
Patients receive oral selenomethionine and oral finasteride once daily for 4-5 weeks.
Selenomethionine: Given orally
Finasteride: Given orally
|
Arm C: Finasteride Placebo + Selenium Placebo
Patients receive two oral placebos once daily for 4-5 weeks.
Placebo: Given orally
|
Arm D: Finasteride Placebo + Selenium
Patients receive oral selenomethionine and oral placebo once daily for 4-5 weeks.
Selenomethionine: Given orally
Placebo: Given orally
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
13
|
15
|
14
|
13
|
|
Overall Study
COMPLETED
|
13
|
13
|
14
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
0
|
0
|
Reasons for withdrawal
| Measure |
Arm A: Finasteride + Selenium Placebo
Patients receive oral placebo and oral finasteride once daily for 4-5 weeks.
Finasteride: Given orally
Placebo: Given orally
|
Arm B: Finasteride + Selenium
Patients receive oral selenomethionine and oral finasteride once daily for 4-5 weeks.
Selenomethionine: Given orally
Finasteride: Given orally
|
Arm C: Finasteride Placebo + Selenium Placebo
Patients receive two oral placebos once daily for 4-5 weeks.
Placebo: Given orally
|
Arm D: Finasteride Placebo + Selenium
Patients receive oral selenomethionine and oral placebo once daily for 4-5 weeks.
Selenomethionine: Given orally
Placebo: Given orally
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
0
|
0
|
Baseline Characteristics
Selenomethionine and Finasteride Before Surgery or Radiation Therapy in Treating Patients With Stage I or Stage II Prostate Cancer
Baseline characteristics by cohort
| Measure |
Arm A: Finasteride + Selenium Placebo
n=13 Participants
Patients receive oral placebo and oral finasteride once daily for 4-5 weeks.
Finasteride: Given orally
Placebo: Given orally
|
Arm B: Finasteride + Selenium
n=15 Participants
Patients receive oral selenomethionine and oral finasteride once daily for 4-5 weeks.
Selenomethionine: Given orally
Finasteride: Given orally
|
Arm C: Finasteride Placebo + Selenium Placebo
n=14 Participants
Patients receive two oral placebos once daily for 4-5 weeks.
Placebo: Given orally
|
Arm D: Finasteride Placebo + Selenium
n=13 Participants
Patients receive oral selenomethionine and oral placebo once daily for 4-5 weeks.
Selenomethionine: Given orally
Placebo: Given orally
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
57.9 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
62.0 years
STANDARD_DEVIATION 7.7 • n=7 Participants
|
61.2 years
STANDARD_DEVIATION 5.2 • n=5 Participants
|
61.9 years
STANDARD_DEVIATION 6.8 • n=4 Participants
|
60.8 years
STANDARD_DEVIATION 6.9 • n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
55 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
50 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: All treated and eligible patients
Compare PSA levels with Finasteride Placebo + Selenium Placebo group (Arm C). The Wilcoxon Rank Sum Test was used to test the difference of PSA levels of Arm A, Arm B, Arm D with Arm C.
Outcome measures
| Measure |
Arm A: Finasteride + Selenium Placebo
n=13 Participants
Patients receive oral placebo and oral finasteride once daily for 4-5 weeks.
Finasteride: Given orally
Placebo: Given orally
|
Arm B: Finasteride + Selenium
n=15 Participants
Patients receive oral selenomethionine and oral finasteride once daily for 4-5 weeks.
Selenomethionine: Given orally
Finasteride: Given orally
|
Arm C: Finasteride Placebo + Selenium Placebo
n=14 Participants
Patients receive two oral placebos once daily for 4-5 weeks.
Placebo: Given orally
|
Arm D: Finasteride Placebo + Selenium
n=13 Participants
Patients receive oral selenomethionine and oral placebo once daily for 4-5 weeks.
Selenomethionine: Given orally
Placebo: Given orally
|
|---|---|---|---|---|
|
Effects of Selenium and Finasteride and Their Combination on PSA Level
|
1.9 ng/mL
Interval 0.8 to 2.6
|
1.9 ng/mL
Interval 1.7 to 2.2
|
2.0 ng/mL
Interval 1.4 to 2.7
|
2.1 ng/mL
Interval 1.3 to 2.7
|
SECONDARY outcome
Timeframe: 1 yearPopulation: All treated and eligible patients
Compare cleaved caspase 3 values with Finasteride Placebo + Selenium Placebo group (Arm C). The Wilcoxon Rank Sum Test was used to test the difference of cleaved caspase 3 values of Arm A, Arm B, Arm D with Arm C.
Outcome measures
| Measure |
Arm A: Finasteride + Selenium Placebo
n=13 Participants
Patients receive oral placebo and oral finasteride once daily for 4-5 weeks.
Finasteride: Given orally
Placebo: Given orally
|
Arm B: Finasteride + Selenium
n=15 Participants
Patients receive oral selenomethionine and oral finasteride once daily for 4-5 weeks.
Selenomethionine: Given orally
Finasteride: Given orally
|
Arm C: Finasteride Placebo + Selenium Placebo
n=14 Participants
Patients receive two oral placebos once daily for 4-5 weeks.
Placebo: Given orally
|
Arm D: Finasteride Placebo + Selenium
n=13 Participants
Patients receive oral selenomethionine and oral placebo once daily for 4-5 weeks.
Selenomethionine: Given orally
Placebo: Given orally
|
|---|---|---|---|---|
|
Effects of Selenium and Finasteride and Their Combination on Apoptosis Induction
|
0.1 percentage of apoptotic cells
Interval 0.0 to 11.1
|
0 percentage of apoptotic cells
Interval 0.0 to 0.7
|
0 percentage of apoptotic cells
Interval 0.0 to 0.4
|
0 percentage of apoptotic cells
Interval 0.0 to 0.7
|
Adverse Events
Arm A: Finasteride + Selenium Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Arm B: Finasteride + Selenium
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm C: Finasteride Placebo + Selenium Placebo
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Arm D: Finasteride Placebo + Selenium
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A: Finasteride + Selenium Placebo
n=13 participants at risk
Patients receive oral placebo and oral finasteride once daily for 4-5 weeks.
Finasteride: Given orally
Placebo: Given orally
|
Arm B: Finasteride + Selenium
n=15 participants at risk
Patients receive oral selenomethionine and oral finasteride once daily for 4-5 weeks.
Selenomethionine: Given orally
Finasteride: Given orally
|
Arm C: Finasteride Placebo + Selenium Placebo
n=14 participants at risk
Patients receive two oral placebos once daily for 4-5 weeks.
Placebo: Given orally
|
Arm D: Finasteride Placebo + Selenium
n=13 participants at risk
Patients receive oral selenomethionine and oral placebo once daily for 4-5 weeks.
Selenomethionine: Given orally
Placebo: Given orally
|
|---|---|---|---|---|
|
Cardiac disorders
Cardiac valve disease
|
0.00%
0/13
|
0.00%
0/15
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/13
|
0.00%
0/15
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/13
|
0.00%
0/15
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/13
|
0.00%
0/15
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.00%
0/13
|
0.00%
0/15
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
Investigations
Urine analysis abnormal
|
0.00%
0/13
|
6.7%
1/15 • Number of events 1
|
0.00%
0/14
|
0.00%
0/13
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/13
|
6.7%
1/15 • Number of events 1
|
0.00%
0/14
|
0.00%
0/13
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/13
|
0.00%
0/15
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/13
|
6.7%
1/15 • Number of events 1
|
0.00%
0/14
|
0.00%
0/13
|
Other adverse events
| Measure |
Arm A: Finasteride + Selenium Placebo
n=13 participants at risk
Patients receive oral placebo and oral finasteride once daily for 4-5 weeks.
Finasteride: Given orally
Placebo: Given orally
|
Arm B: Finasteride + Selenium
n=15 participants at risk
Patients receive oral selenomethionine and oral finasteride once daily for 4-5 weeks.
Selenomethionine: Given orally
Finasteride: Given orally
|
Arm C: Finasteride Placebo + Selenium Placebo
n=14 participants at risk
Patients receive two oral placebos once daily for 4-5 weeks.
Placebo: Given orally
|
Arm D: Finasteride Placebo + Selenium
n=13 participants at risk
Patients receive oral selenomethionine and oral placebo once daily for 4-5 weeks.
Selenomethionine: Given orally
Placebo: Given orally
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
7.7%
1/13 • Number of events 1
|
0.00%
0/15
|
0.00%
0/14
|
0.00%
0/13
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/13
|
0.00%
0/15
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
|
Gastrointestinal disorders
Diarrhoea
|
7.7%
1/13 • Number of events 1
|
0.00%
0/15
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
|
Gastrointestinal disorders
Nausea
|
7.7%
1/13 • Number of events 1
|
6.7%
1/15 • Number of events 1
|
0.00%
0/14
|
0.00%
0/13
|
|
General disorders
Fatigue
|
0.00%
0/13
|
0.00%
0/15
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
|
Infections and infestations
Orchitis
|
0.00%
0/13
|
0.00%
0/15
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/13
|
6.7%
1/15 • Number of events 1
|
0.00%
0/14
|
0.00%
0/13
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/13
|
0.00%
0/15
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/13
|
6.7%
1/15 • Number of events 1
|
0.00%
0/14
|
0.00%
0/13
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/13
|
0.00%
0/15
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
|
Nervous system disorders
Headache
|
0.00%
0/13
|
6.7%
1/15 • Number of events 1
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/13
|
0.00%
0/15
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/13
|
6.7%
1/15 • Number of events 1
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/13
|
0.00%
0/15
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/13
|
6.7%
1/15 • Number of events 1
|
0.00%
0/14
|
0.00%
0/13
|
Additional Information
Senior Administrator, Compliance - Clinical Research Services
Roswell Park Cancer Institute
Phone: 716-845-2300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place