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Biomarkers of Sulforaphane/Broccoli Sprout Extract in Prostate Cancer

Primary Purpose

Prostate Cancer

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

BroccoMax®

Placebo

About this trial

This is an interventional basic science trial for Prostate Cancer focused on measuring prostatectomy

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Men ≥ 18 years of age scheduled to undergo radical prostatectomy as standard of care for a diagnosis of prostate adenocarcinoma.
Subjects willing to take oral placebo or BroccoMax® pills (4 capsules twice daily after breakfast and dinner) on a daily basis for 4 weeks prior to prostatectomy. Subjects have the ability to swallow BroccoMax® or placebo pills.
Subjects in good health per investigator evaluation with liver enzyme and blood count values within the following ranges:
White blood cells ≥ 3,000/mL Total bilirubin ≤ 1.5 x Upper Limits of Normal (ULN) Aspartate Aminotransferase (AST (SGOT))/ Alanine Aminotransferase (ALT (SGPT)) ≤ 2.5 x ULN Blood Urea Nitrogen (BUN) and serum creatinine ≤ 1.5 x ULN
Subjects willing to abstain from dietary sources of glucosinolates and isothiocyanates (see Appendix) for the duration of the study (4 weeks)
Subjects must be fully informed of the investigational nature of this study and must sign a written informed consent in accordance within institutional and regulatory guidelines

Exclusion Criteria:

Subjects ineligible to undergo prostatectomy due to co-morbidities.
Subjects with a second malignancy or any other cancer at least 3 years following definitive treatment with no evidence of disease, except for adequately treated basal cell or squamous cell skin cancer.
Subjects with malabsorption issues or gastrointestinal ailments than can interfere with the ability to adequately absorb SFN.
Subjects with prior or concurrent androgen deprivation therapy with Luteinizing hormone-releasing hormone (LHRH) agonist or antagonists
Subjects taking any other investigational agent, dietary supplement or herbal supplement or participating in clinical studies involving investigational agents
Subjects with clinically significant comorbid diseases including active infection, uncontrolled angina, New York Heart Assoc. (NYHA) class III or IV heart failure, uncontrolled or uncontrollable hypertension, severe diabetes with complications, chronic liver disease.
Subjects with prior history of known intolerance or allergic reactions attributed to cruciferous vegetables or specific fillers used in the placebo.

Sites / Locations

Shadyside Urology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BroccoMax®

Placebo

Arm Description

Following randomization, subjects will begin to take four BroccoMax® tablets in the morning with breakfast and four tablets in the evening with dinner. The eight BroccoMax® tablets will provide a daily internal dose of 64 mg of SFN.

Following randomization, subjects will begin to take four placebo tablets in the morning with breakfast and four tablets in the evening with dinner.

Outcomes

Primary Outcome Measures

Palmitic Acid Reduction

Change in serum levels of palmitic acid (the primary free fatty acid) in subjects treated with BroccoMax® compared to placebo.

Secondary Outcome Measures

Evaluation of safety of BroccoMax® (side effects or adverse events)

Assessing any side effects or adverse events that could be associated with the oral intake of BroccoMax®

Serum SFN levels

Compare the levels of SFN and its metabolites in serum at day 14 and week 4 to baseline

Urine SFN levels

Compare the levels of SFN and its metabolites in urine at day 14 and week 4 to baseline.

Prostate adenocarcinoma SFN level

Evaluate the SFN and its metabolites in the prostate/ prostate adenocarcinoma tissue.

Mean proliferative index (Ki-67) and apoptotic marker (TUNEL) in prostate adenocarcinoma sections

Evaluate the biomarkers of the collected tissue.

Evaluation of Prostate adenocarcinoma tissue by immunohistochemistry.

Prostate adenocarcinoma expression of acetyl-Coenzyme A carboxylase 1 (ACC1), fatty acid synthase (FASN), carnitine palmitoyltransferase1A (CPT1A), androgen receptor (AR), phosphatase and tensin homolog (PTEN), sterol regulatory binding protein 1 (SREBP-1) and c-Myc by immunohistochemistry (IHC)

Evaluation of serum levels of fatty acid metabolism intermediates.

Evaluate Serum levels of Acetyl-Coenzyme A, Malonyl-Coenzyme A, total phospholipids, adenosine triphosphate (ATP), and global lipidemic

Evaluation of prostate adenocarcinoma levels of fatty acid metabolism intermediates

Evaluate prostate adenocarcinoma levels of Acetyl-Coenzyme A, Malonyl-Coenzyme A, total phospholipids, ATP, and global lipidemic

Full Information

NCT ID

NCT03665922

First Posted

September 5, 2018

Last Updated

July 9, 2023

Sponsor

University of Pittsburgh

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT03665922

Brief Title

Biomarkers of Sulforaphane/Broccoli Sprout Extract in Prostate Cancer

Official Title

Biomarkers of Sulforaphane/Broccoli Sprout Extract in Prostate Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

May 1, 2019 (Actual)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Pittsburgh

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study will test whether oral intake of a dietary supplement called BroccoMax®, which is a special blend of broccoli extract containing a chemical called sulforaphane (hereafter abbreviated as SFN), may result in changes in chemicals that feed prostate cancer. BroccoMax® is available over the counter.

Detailed Description

Eligible subjects will be randomly assigned to either BroccoMax® or placebo arm with a 1:1 randomization. Each subject will be given BroccoMax® equivalent to 4 weeks supply. Following randomization, subjects will begin to take four study tablets (BroccoMax® or placebo) in the morning with breakfast and four tablets in the evening with dinner. The eight BroccoMax® tablets will provide a daily internal dose of 64 mg of SFN. Baseline evaluation will be 28 days before scheduled prostatectomy, the same day of study drug dispensation, and will include. Data collection on patient's medical history (which includes age, cancer history, review of medications, food intolerances and food habits), and concomitant medications. Physical exam including height and weight measurements. Blood (approximately 15 mL) will be collected in Serum Separator Tube-tiger tubes (SST)for determination of SFN and its metabolite levels and for biomarker analyses. Spot urine collection (15 mL) for measuring SFN and its metabolite levels. Four-week supply of study drug (BroccoMax® or Placebo) dispensation Day 28 ± 3 days (End of study evaluation) Physical exam including height and weight measurements Blood (approximately 15 mL) will be collected in SST-tiger tubes for determination of SFN and its metabolite levels and for biomarker analyses. Spot urine collection (15 mL) for measuring SFN and its metabolite levels. Adverse event assessment. A portion of the prostate tumor after surgical resection will be fresh frozen in liquid nitrogen. After pathological assessment is complete, tumor blocks or slides (6 or more) will be requested by the clinical research coordinator from the Health Sciences Tissue Bank of the University of Pittsburgh for biomarker analyses. Post-Treatment Follow-Up All study participants will have routine follow-up as determined by their treating urologist and/ or medical oncologist. This usually occurs 6 ± 2 weeks post-surgery and every 3 months thereafter. These are considered standard of care visits. The patient chart will be reviewed for their history and physical findings at these visits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

prostatectomy

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Double-blind randomized placebo controlled design

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

39 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BroccoMax®

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Following randomization, subjects will begin to take four placebo tablets in the morning with breakfast and four tablets in the evening with dinner.

Intervention Type

Dietary Supplement

Intervention Name(s)

BroccoMax®

Intervention Description

Nutraceutical neoadjuvant

Intervention Type

Other

Intervention Name(s)

Placebo

Other Intervention Name(s)

Microcrystalline cellulose

Intervention Description

control

Primary Outcome Measure Information:

Title

Palmitic Acid Reduction

Description

Change in serum levels of palmitic acid (the primary free fatty acid) in subjects treated with BroccoMax® compared to placebo.

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Evaluation of safety of BroccoMax® (side effects or adverse events)

Description

Assessing any side effects or adverse events that could be associated with the oral intake of BroccoMax®

Time Frame

2 months

Title

Serum SFN levels

Description

Compare the levels of SFN and its metabolites in serum at day 14 and week 4 to baseline

Time Frame

4 weeks

Title

Urine SFN levels

Description

Compare the levels of SFN and its metabolites in urine at day 14 and week 4 to baseline.

Time Frame

4 weeks

Title

Prostate adenocarcinoma SFN level

Description

Evaluate the SFN and its metabolites in the prostate/ prostate adenocarcinoma tissue.

Time Frame

Week 4

Title

Mean proliferative index (Ki-67) and apoptotic marker (TUNEL) in prostate adenocarcinoma sections

Description

Evaluate the biomarkers of the collected tissue.

Time Frame

Week 4

Title

Evaluation of Prostate adenocarcinoma tissue by immunohistochemistry.

Description

Time Frame

Week 4

Title

Evaluation of serum levels of fatty acid metabolism intermediates.

Description

Evaluate Serum levels of Acetyl-Coenzyme A, Malonyl-Coenzyme A, total phospholipids, adenosine triphosphate (ATP), and global lipidemic

Time Frame

Weeks 2 and 4.

Title

Evaluation of prostate adenocarcinoma levels of fatty acid metabolism intermediates

Description

Evaluate prostate adenocarcinoma levels of Acetyl-Coenzyme A, Malonyl-Coenzyme A, total phospholipids, ATP, and global lipidemic

Time Frame

Week 4

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Men ≥ 18 years of age scheduled to undergo radical prostatectomy as standard of care for a diagnosis of prostate adenocarcinoma. Subjects willing to take oral placebo or BroccoMax® pills (4 capsules twice daily after breakfast and dinner) on a daily basis for 4 weeks prior to prostatectomy. Subjects have the ability to swallow BroccoMax® or placebo pills. Subjects in good health per investigator evaluation with liver enzyme and blood count values within the following ranges: White blood cells ≥ 3,000/mL Total bilirubin ≤ 1.5 x Upper Limits of Normal (ULN) Aspartate Aminotransferase (AST (SGOT))/ Alanine Aminotransferase (ALT (SGPT)) ≤ 2.5 x ULN Blood Urea Nitrogen (BUN) and serum creatinine ≤ 1.5 x ULN Subjects willing to abstain from dietary sources of glucosinolates and isothiocyanates (see Appendix) for the duration of the study (4 weeks) Subjects must be fully informed of the investigational nature of this study and must sign a written informed consent in accordance within institutional and regulatory guidelines Exclusion Criteria: Subjects ineligible to undergo prostatectomy due to co-morbidities. Subjects with a second malignancy or any other cancer at least 3 years following definitive treatment with no evidence of disease, except for adequately treated basal cell or squamous cell skin cancer. Subjects with malabsorption issues or gastrointestinal ailments than can interfere with the ability to adequately absorb SFN. Subjects with prior or concurrent androgen deprivation therapy with Luteinizing hormone-releasing hormone (LHRH) agonist or antagonists Subjects taking any other investigational agent, dietary supplement or herbal supplement or participating in clinical studies involving investigational agents Subjects with clinically significant comorbid diseases including active infection, uncontrolled angina, New York Heart Assoc. (NYHA) class III or IV heart failure, uncontrolled or uncontrollable hypertension, severe diabetes with complications, chronic liver disease. Subjects with prior history of known intolerance or allergic reactions attributed to cruciferous vegetables or specific fillers used in the placebo.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bruce Jacobs, MD

Organizational Affiliation

University of Pittsburgh

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shadyside Urology

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15232

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Citation

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Biomarkers of Sulforaphane/Broccoli Sprout Extract in Prostate Cancer

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