NCT03532308

Nutrition and Prostate Cancer

Terminated Phase 3 Results posted Last updated 26 May 2021

What this trial tests

Phase 3 trial testing Fermented Soy in Prostate Cancer in 19 participants. Terminated before completion.

Timeline

21 November 2018

Primary endpoint
14 December 2019

14 December 2019

Quick facts

Lead sponsor	Yale University
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	19
Start date	21 November 2018
Primary completion	14 December 2019
Estimated completion	14 December 2019
Sites	3 locations across United States

Drugs / interventions tested

• Fermented Soy — full drug profile →
• Placebo

Conditions studied

• Prostate Cancer — all drugs for Prostate Cancer →

Sponsor

Yale University

Who can join

18 and older, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Prostate-specific Antigen (PSA) Primary · Greater than or equal to 4 weeks (up to 10 weeks)

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.

Baseline

Group	Value	95% CI
Intervention	8.97	± 1.10
Placebo	8.66	± 1.16

Up to 10 Weeks

Group	Value	95% CI
Intervention	8.11	± 1.12
Placebo	8.92	± 1.21

Gleason Score Secondary · Greater than or equal to 4 weeks (up to 10 weeks)

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).

Group	Value	95% CI
Intervention	7
Placebo	5
Intervention	0
Placebo	2
Intervention	1
Placebo	1

Cancer of the Prostate Risk Assessment (CAPRA-S) Score Change Secondary · Baseline to final visit (up to 10 weeks)

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.

Group	Value	95% CI
Intervention	-1.3	± 0.9
Placebo	-1.4	± 1.3

Functional Assessment of Cancer Therapy - Prostate (FACT-P v4©) Secondary · Greater than or equal to 4 weeks (up to 10 weeks)

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.

Baseline

Group	Value	95% CI
Intervention	121.50	104.47 – 138.53
Placebo	128.44	118.07 – 138.82

End of Study (up to 10 weeks)

Group	Value	95% CI
Intervention	126.00	113.04 – 138.96
Placebo	123.25	112.79 – 133.71

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 10 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Intervention

Serious: 1/10 (10%)

Deaths: 0/10

Placebo

Serious: 0/9 (0%)

Deaths: 0/9

Serious adverse events (2 terms)

Reaction	System	Intervention	Placebo
Pneumonia	Respiratory, thoracic and mediastinal disorders	—	—
Aortic Aneurysm	Cardiac disorders	—	—

Other adverse events (3 terms — click to expand)

Reaction	System	Intervention	Placebo
Rash	Skin and subcutaneous tissue disorders	—	—
Nausea/Dizzyness	Nervous system disorders	—	—
Atrial Fibrillation	Cardiac disorders	—	—

Most-reported serious reactions: Pneumonia, Aortic Aneurysm.

Data from ClinicalTrials.gov NCT03532308 adverse events section.

Sponsor's own description

The purpose of this study is to assess the efficacy of Fermented Soy vs. placebo in 72 adults with localized prostate cancer prior to radical prostatectomy.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A Randomized Controlled Trial of a Fermented Soy Beverage Among Patients with Localized Prostate Cancer Prior to Radical Prostatectomy
   Lokeshwar SD, Ali A, Weiss TR, Reynolds J, et al · · 2023 · DOI 10.21203/rs.3.rs-3240223/v1