Black Raspberry Products for Prostate Cancer

Overseen by Steven Clinton, MD

Age: Any Age

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Ohio State University Comprehensive Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial uses dried black raspberries in gummies and juice to see if they can help men having surgery for prostate cancer by changing hormone levels and reducing cancer-related markers.

Research Team

Steven Clinton, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

Men with confirmed prostate cancer who have chosen surgery (radical prostatectomy) as their treatment and are not on hormone/chemotherapy or other clinical trials. They should not be taking berry supplements, must have normal kidney and liver function, normal blood counts, and clotting times. Participants need to be relatively healthy (ECOG status 0-1) and willing to consent.

Inclusion Criteria

Have BUN/Cr (blood urea nitrogen and serum creatinine) within normal limits

Have prothrombin time/partial thromboplastin time (PT/PTT/INR) within normal limits

Agree to follow a controlled polyphenolic and/ or ellagitannin diet

Exclusion Criteria

Have a known allergy to black raspberries, corn, and wheat products or those who have never consumed any of these products

My prostate biopsy shows less than 5% cancer involvement.

I have trouble swallowing or experience pain when swallowing, and I may have dry mouth or issues with my salivary glands.

Treatment Details

Interventions

• Lyophilized Black Raspberry Confection (Phytochemical)

Trial Overview The trial is examining how men with prostate cancer absorb and process compounds from black raspberries before their surgery. It involves eating a special raspberry confection, filling out questionnaires, undergoing lab tests for biomarkers related to cancer, and assessing quality of life.

Participant Groups

Group I: Arm VII (higher-dose black raspberry confection) Experimental Treatment 5 Interventions

Patients follow a low ellagitannin diet and receive higher-dose black raspberry confection PO daily for 4-6 weeks and then undergo prostatectomy.

Group II: Arm VI (lower-dose black raspberry confection) Experimental Treatment 5 Interventions

Patients follow a low ellagitannin diet and receive lower-dose black raspberry confection PO daily for 4-6 weeks and then undergo prostatectomy.

Group III: Arm V (higher-dose black raspberry gummy) Experimental Treatment 5 Interventions

Patients follow a low ellagitannin diet and receive higher-dose black raspberry gummy PO daily for 4-6 weeks and then undergo prostatectomy.

Group IV: Arm IV (lower-dose lyophilized black raspberry gummy) Experimental Treatment 5 Interventions

Patients follow a low ellagitannin diet and receive lower-dose black raspberry gummy PO daily for 4-6 weeks and then undergo prostatectomy.

Group V: Arm III (low ellagitannin diet) Active Control 4 Interventions

Patients follow a low ellagitannin diet for 4-6 weeks and then undergo prostatectomy.

Group VI: Arm I (regular diet) Active Control 3 Interventions

Patients follow a regular diet for 4-6 weeks and then undergo prostatectomy.

Group VII: Arm II (low polyphenol diet) Active Control 4 Interventions

Patients follow a low polyphenol diet for 4-6 weeks and then undergo prostatectomy.

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

Dr. David Cohn

Ohio State University Comprehensive Cancer Center

Interim Chief Executive Officer since 2022

MD, MBA

Dr. David Cohn

Ohio State University Comprehensive Cancer Center

Chief Medical Officer since 2018

MD