Trial Outcomes & Findings for Nutrition and Prostate Cancer (NCT NCT03532308)
NCT ID: NCT03532308
Last Updated: 2021-05-26
Results Overview
The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are usually reported as nanograms of PSA per milliliter (ng/mL) of blood. The PSA range of scores and interpretation are as follows: Normal PSA Levels: 0 - 4 ng/mL, Slightly Elevated PSA: 4 - 10 ng/mL, Moderately Elevated PSA: 10 - 20 ng/mL, Highly Elevated PSA: 20+ ng/mL. Interpretation of these scores is also based on the age of the inidividual.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
19 participants
Primary outcome timeframe
Greater than or equal to 4 weeks (up to 10 weeks)
Results posted on
2021-05-26
Participant Flow
Participant milestones
| Measure |
Intervention
Daily Fermented Soy (two 12.5g packets/day) (\~1 ounce/day) taken between the time of enrollment and radical prostatectomy (RP). Clinical assessment of both groups will take place 1) at baseline, and 2) just prior to RP, estimated at between 4 and 10 weeks from baseline/enrollment. Length of time in the study will vary for each subject, depending on how far out their prostatectomy will occur; all prostatectomies will be scheduled to occur between 4-10 weeks post-baseline.
Fermented Soy: Two 12.5g packets/day) (\~1 ounce/day) taken between the time of enrollment and radical prostatectomy (RP). Time can be between 4 and 10 weeks.
|
Placebo
Daily (matched dose) taken between the time of enrollment and radical prostatectomy (RP). Clinical assessment of both groups will take place 1) at baseline, and 2) just prior to RP, estimated at between 4 and 10 weeks from baseline/enrollment. Length of time in the study will vary for each subject, depending on how far out their prostatectomy will occur; all prostatectomies will be scheduled to occur between 4-10 weeks post-baseline.
Placebo: A placebo compliment to the active intervention with identical packaging and labeling will be used.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
9
|
|
Overall Study
Completed Assessments
|
9
|
7
|
|
Overall Study
COMPLETED
|
10
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nutrition and Prostate Cancer
Baseline characteristics by cohort
| Measure |
Intervention
n=10 Participants
Daily Fermented Soy (two 12.5g packets/day) (\~1 ounce/day) taken between the time of enrollment and radical prostatectomy (RP). Clinical assessment of both groups will take place 1) at baseline, and 2) just prior to RP, estimated at between 4 and 10 weeks from baseline/enrollment. Length of time in the study will vary for each subject, depending on how far out their prostatectomy will occur; all prostatectomies will be scheduled to occur between 4-10 weeks post-baseline.
Fermented Soy: Two 12.5g packets/day) (\~1 ounce/day) taken between the time of enrollment and radical prostatectomy (RP). Time can be between 4 and 10 weeks.
|
Placebo
n=9 Participants
Daily (matched dose) taken between the time of enrollment and radical prostatectomy (RP). Clinical assessment of both groups will take place 1) at baseline, and 2) just prior to RP, estimated at between 4 and 10 weeks from baseline/enrollment. Length of time in the study will vary for each subject, depending on how far out their prostatectomy will occur; all prostatectomies will be scheduled to occur between 4-10 weeks post-baseline.
Placebo: A placebo compliment to the active intervention with identical packaging and labeling will be used.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.6 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
62.9 years
STANDARD_DEVIATION 6.4 • n=7 Participants
|
61.7 years
STANDARD_DEVIATION 6.6 • 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
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 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
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
9 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
CAPRA Score
0-5: Low/Intermediate risk
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
CAPRA Score
6-10: High risk
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Greater than or equal to 4 weeks (up to 10 weeks)Population: Intention to treat analysis population.
The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are usually reported as nanograms of PSA per milliliter (ng/mL) of blood. The PSA range of scores and interpretation are as follows: Normal PSA Levels: 0 - 4 ng/mL, Slightly Elevated PSA: 4 - 10 ng/mL, Moderately Elevated PSA: 10 - 20 ng/mL, Highly Elevated PSA: 20+ ng/mL. Interpretation of these scores is also based on the age of the inidividual.
Outcome measures
| Measure |
Intervention
n=10 Participants
Daily Fermented Soy (two 12.5g packets/day) (\~1 ounce/day) taken between the time of enrollment and radical prostatectomy (RP). Clinical assessment of both groups will take place 1) at baseline, and 2) just prior to RP, estimated at between 4 and 10 weeks from baseline/enrollment. Length of time in the study will vary for each subject, depending on how far out their prostatectomy will occur; all prostatectomies will be scheduled to occur between 4-10 weeks post-baseline.
Fermented Soy: Two 12.5g packets/day) (\~1 ounce/day) taken between the time of enrollment and radical prostatectomy (RP). Time can be between 4 and 10 weeks.
|
Placebo
n=9 Participants
Daily (matched dose) taken between the time of enrollment and radical prostatectomy (RP). Clinical assessment of both groups will take place 1) at baseline, and 2) just prior to RP, estimated at between 4 and 10 weeks from baseline/enrollment. Length of time in the study will vary for each subject, depending on how far out their prostatectomy will occur; all prostatectomies will be scheduled to occur between 4-10 weeks post-baseline.
Placebo: A placebo compliment to the active intervention with identical packaging and labeling will be used.
|
|---|---|---|
|
Prostate-specific Antigen (PSA)
Baseline
|
8.97 ng/mL
Standard Error 1.10
|
8.66 ng/mL
Standard Error 1.16
|
|
Prostate-specific Antigen (PSA)
Up to 10 Weeks
|
8.11 ng/mL
Standard Error 1.12
|
8.92 ng/mL
Standard Error 1.21
|
SECONDARY outcome
Timeframe: Greater than or equal to 4 weeks (up to 10 weeks)Population: Participants that were available for assessment at the end of treatment/study.
Pathological investigation of the removed prostate gland will include the assessment of biopsy-proven, index prostate cancer lesion will lead to the analysis of any modulation of PCa grade (Gleason score) compared to preoperative biopsies. The Gleason Score is interpreted as follows: 3+4 (Prognosis = Good), 4+3 (Prognosis = Likely to Spread), 8 - 10 (Prognosis = Likely to Spread Rapidly).
Outcome measures
| Measure |
Intervention
n=8 Participants
Daily Fermented Soy (two 12.5g packets/day) (\~1 ounce/day) taken between the time of enrollment and radical prostatectomy (RP). Clinical assessment of both groups will take place 1) at baseline, and 2) just prior to RP, estimated at between 4 and 10 weeks from baseline/enrollment. Length of time in the study will vary for each subject, depending on how far out their prostatectomy will occur; all prostatectomies will be scheduled to occur between 4-10 weeks post-baseline.
Fermented Soy: Two 12.5g packets/day) (\~1 ounce/day) taken between the time of enrollment and radical prostatectomy (RP). Time can be between 4 and 10 weeks.
|
Placebo
n=8 Participants
Daily (matched dose) taken between the time of enrollment and radical prostatectomy (RP). Clinical assessment of both groups will take place 1) at baseline, and 2) just prior to RP, estimated at between 4 and 10 weeks from baseline/enrollment. Length of time in the study will vary for each subject, depending on how far out their prostatectomy will occur; all prostatectomies will be scheduled to occur between 4-10 weeks post-baseline.
Placebo: A placebo compliment to the active intervention with identical packaging and labeling will be used.
|
|---|---|---|
|
Gleason Score
3+4 (Prognosis = Good)
|
7 Participants
|
5 Participants
|
|
Gleason Score
4+3 (Prognosis = Likely to Spread)
|
0 Participants
|
2 Participants
|
|
Gleason Score
8 - 10 (Prognosis = Likely to Spread Rapidly)
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Greater than or equal to 4 weeks (up to 10 weeks)Population: These data were not collected due to early termination of the study.
Analysis of telomere length in research samples of human peripheral blood mononuclear cells reveals that telomere length decreases with increased replication of cells, reflecting the replicative history of those cells.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to final visit (up to 10 weeks)Population: Per protocol change in scores from baseline in those with complete data at baseline and end of study/treatment.
Post surgical/post intervention CAPRA score will be used for comparison with baseline (screening) value. The CAPRA score can range from 0 to 10 where: a score of 0 to 2 indicates low-risk, 3 to 5 indicates intermediate-risk, and 6 to 10 indicates high-risk.
Outcome measures
| Measure |
Intervention
n=8 Participants
Daily Fermented Soy (two 12.5g packets/day) (\~1 ounce/day) taken between the time of enrollment and radical prostatectomy (RP). Clinical assessment of both groups will take place 1) at baseline, and 2) just prior to RP, estimated at between 4 and 10 weeks from baseline/enrollment. Length of time in the study will vary for each subject, depending on how far out their prostatectomy will occur; all prostatectomies will be scheduled to occur between 4-10 weeks post-baseline.
Fermented Soy: Two 12.5g packets/day) (\~1 ounce/day) taken between the time of enrollment and radical prostatectomy (RP). Time can be between 4 and 10 weeks.
|
Placebo
n=8 Participants
Daily (matched dose) taken between the time of enrollment and radical prostatectomy (RP). Clinical assessment of both groups will take place 1) at baseline, and 2) just prior to RP, estimated at between 4 and 10 weeks from baseline/enrollment. Length of time in the study will vary for each subject, depending on how far out their prostatectomy will occur; all prostatectomies will be scheduled to occur between 4-10 weeks post-baseline.
Placebo: A placebo compliment to the active intervention with identical packaging and labeling will be used.
|
|---|---|---|
|
Cancer of the Prostate Risk Assessment (CAPRA-S) Score Change
|
-1.3 units on a scale
Standard Deviation 0.9
|
-1.4 units on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Greater than or equal to 4 weeks (up to 10 weeks)Population: These data were not collected due to early termination of the study.
Assessment of prostate cancer mRNA can be determined from PCa tissue. Cell cycle progression score assessment of PCa mRNA is a novel RNA expression-based assay that directly measures tumor cell growth characteristics in order to stratify patients with localized PCa according to disease aggressiveness.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Greater than or equal to 4 weeks (up to 10 weeks)Population: Presented are data for all participants with complete data.
Quality of life assessment for men with PCa will be assessed with the Functional Assessment of Cancer Therapy - Prostate (FACT-P v4©). The FACT-P contains 39 items that use a 0-4 rating scale. The highest possible score is 156 (lowest possible score = 0). The total score is an indication of overall quality of life where the higher scores indicate better quality of life.
Outcome measures
| Measure |
Intervention
n=10 Participants
Daily Fermented Soy (two 12.5g packets/day) (\~1 ounce/day) taken between the time of enrollment and radical prostatectomy (RP). Clinical assessment of both groups will take place 1) at baseline, and 2) just prior to RP, estimated at between 4 and 10 weeks from baseline/enrollment. Length of time in the study will vary for each subject, depending on how far out their prostatectomy will occur; all prostatectomies will be scheduled to occur between 4-10 weeks post-baseline.
Fermented Soy: Two 12.5g packets/day) (\~1 ounce/day) taken between the time of enrollment and radical prostatectomy (RP). Time can be between 4 and 10 weeks.
|
Placebo
n=9 Participants
Daily (matched dose) taken between the time of enrollment and radical prostatectomy (RP). Clinical assessment of both groups will take place 1) at baseline, and 2) just prior to RP, estimated at between 4 and 10 weeks from baseline/enrollment. Length of time in the study will vary for each subject, depending on how far out their prostatectomy will occur; all prostatectomies will be scheduled to occur between 4-10 weeks post-baseline.
Placebo: A placebo compliment to the active intervention with identical packaging and labeling will be used.
|
|---|---|---|
|
Functional Assessment of Cancer Therapy - Prostate (FACT-P v4©)
Baseline
|
121.50 units on a scale
Interval 104.47 to 138.53
|
128.44 units on a scale
Interval 118.07 to 138.82
|
|
Functional Assessment of Cancer Therapy - Prostate (FACT-P v4©)
End of Study (up to 10 weeks)
|
126.00 units on a scale
Interval 113.04 to 138.96
|
123.25 units on a scale
Interval 112.79 to 133.71
|
Adverse Events
Intervention
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intervention
n=10 participants at risk
Daily Fermented Soy (two 12.5g packets/day) (\~1 ounce/day) taken between the time of enrollment and radical prostatectomy (RP). Clinical assessment of both groups will take place 1) at baseline, and 2) just prior to RP, estimated at between 4 and 10 weeks from baseline/enrollment. Length of time in the study will vary for each subject, depending on how far out their prostatectomy will occur; all prostatectomies will be scheduled to occur between 4-10 weeks post-baseline.
Fermented Soy: Two 12.5g packets/day) (\~1 ounce/day) taken between the time of enrollment and radical prostatectomy (RP). Time can be between 4 and 10 weeks.
|
Placebo
n=9 participants at risk
Daily (matched dose) taken between the time of enrollment and radical prostatectomy (RP). Clinical assessment of both groups will take place 1) at baseline, and 2) just prior to RP, estimated at between 4 and 10 weeks from baseline/enrollment. Length of time in the study will vary for each subject, depending on how far out their prostatectomy will occur; all prostatectomies will be scheduled to occur between 4-10 weeks post-baseline.
Placebo: A placebo compliment to the active intervention with identical packaging and labeling will be used.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
10.0%
1/10 • Number of events 1 • Up to 10 weeks
|
0.00%
0/9 • Up to 10 weeks
|
|
Cardiac disorders
Aortic Aneurysm
|
10.0%
1/10 • Number of events 1 • Up to 10 weeks
|
0.00%
0/9 • Up to 10 weeks
|
Other adverse events
| Measure |
Intervention
n=10 participants at risk
Daily Fermented Soy (two 12.5g packets/day) (\~1 ounce/day) taken between the time of enrollment and radical prostatectomy (RP). Clinical assessment of both groups will take place 1) at baseline, and 2) just prior to RP, estimated at between 4 and 10 weeks from baseline/enrollment. Length of time in the study will vary for each subject, depending on how far out their prostatectomy will occur; all prostatectomies will be scheduled to occur between 4-10 weeks post-baseline.
Fermented Soy: Two 12.5g packets/day) (\~1 ounce/day) taken between the time of enrollment and radical prostatectomy (RP). Time can be between 4 and 10 weeks.
|
Placebo
n=9 participants at risk
Daily (matched dose) taken between the time of enrollment and radical prostatectomy (RP). Clinical assessment of both groups will take place 1) at baseline, and 2) just prior to RP, estimated at between 4 and 10 weeks from baseline/enrollment. Length of time in the study will vary for each subject, depending on how far out their prostatectomy will occur; all prostatectomies will be scheduled to occur between 4-10 weeks post-baseline.
Placebo: A placebo compliment to the active intervention with identical packaging and labeling will be used.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
10.0%
1/10 • Number of events 1 • Up to 10 weeks
|
0.00%
0/9 • Up to 10 weeks
|
|
Nervous system disorders
Nausea/Dizzyness
|
10.0%
1/10 • Number of events 1 • Up to 10 weeks
|
0.00%
0/9 • Up to 10 weeks
|
|
Cardiac disorders
Atrial Fibrillation
|
10.0%
1/10 • Number of events 1 • Up to 10 weeks
|
11.1%
1/9 • Number of events 1 • Up to 10 weeks
|
Additional Information
Michael S. Leapman, MD
Yale University School of Medicine
Phone: (203) 785-2815
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place