Nutrition and Prostate Cancer

NCT03532308 | Terminated Phase 3 Results DMC FDA Drug

• 1 other identifier: 2000020868
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

Fermented Soy

Outcome Measures

Primary Outcomes (1)

• Prostate-specific Antigen (PSA)

  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.

  Greater than or equal to 4 weeks (up to 10 weeks)

Secondary Outcomes (5)

• Gleason Score

  Greater than or equal to 4 weeks (up to 10 weeks)

• PCa Tissue Telomeric DNA Length

  Greater than or equal to 4 weeks (up to 10 weeks)

• Cancer of the Prostate Risk Assessment (CAPRA-S) Score Change

  Baseline to final visit (up to 10 weeks)

• Cell Cycle Progression Score

  Greater than or equal to 4 weeks (up to 10 weeks)

• Functional Assessment of Cancer Therapy - Prostate (FACT-P v4©)

  Greater than or equal to 4 weeks (up to 10 weeks)

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Drug: Fermented Soy

Placebo

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

Fermented Soy DRUG

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.

Also known as: Q-CAN Plus

Intervention

Placebo OTHER

A placebo compliment to the active intervention with identical packaging and labeling will be used.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically verified Prostate Cancer (at any stage)
• Scheduled to be treated by radical prostatectomy within the next 4-10 weeks
• Understanding and willingness to provide consent

You may not qualify if:

• Previous (within 6 months of enrollment) or concurrent hormonal therapy or chemotherapy; specifically, treatment with 5-alpha reductase inhibitors (finasteride and dutasteride)
• History of hormone dependent malignancies
• Concomitant thyroid disease or currently taking thyroid hormone replacement medication
• Current high-dose soy consumption, micronutrient, or herbal supplements, on soy or vegetarian nutrition, or any other extreme dietary habits
• Current or past history of any liver or pancreas disease
• History of allergy or hypersensitivity to soy-containing products
• Malabsorption conditions that might interfere with absorption of the investigational product

Sponsors & Collaborators

• Yale University: lead

Study Sites (3)

Yale University

New Haven, Connecticut, 06520, United States

Location

Yale New Haven Health- Lawrence + Memorial Hospital

New London, Connecticut, 06320, United States

Location

South County Hospital

Wakefield, Rhode Island, 02879, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Michael S. Leapman, MD
• Organization: Yale University School of Medicine

michael.leapman@yale.edu

(203) 785-2815

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2018
• First Posted: May 22, 2018
• Study Start: November 21, 2018
• Primary Completion: December 14, 2019
• Study Completion: December 14, 2019
• Last Updated: May 26, 2021
• Results First Posted: May 6, 2021

Record last verified: 2021-05

Locations

US (3)