What side effects are associated with this type of intervention?

Common treatments for prostate cancer, particularly those involving dietary supplements and herbal treatments like saw palmetto, pomegranate, and modified citrus pectin, generally have mild side effects. Saw palmetto may cause headache, nausea, and dizziness, but these are infrequent and comparable to placebo. Pomegranate intake has not shown significant adverse effects in controlled trials. Modified citrus pectin has been associated with gastrointestinal discomfort in some cases. It is important to note that while these treatments are generally well-tolerated, their efficacy in treating prostate cancer remains unproven, and they should be used under medical supervision.

What prior FDA approvals exist?

FDA-approved treatments for prostate cancer include a variety of drugs and therapies. These range from androgen receptor signaling inhibitors like enzalutamide and abiraterone, to taxane-based chemotherapies such as docetaxel and cabazitaxel. Additionally, radioligand therapy with lutetium Lu 177 vipivotide tetraxetan has been approved for PSMA-positive metastatic castration-resistant prostate cancer. While specific phytochemicals from black raspberries are not mentioned among FDA-approved treatments, other plant-derived compounds like modified citrus pectin have shown potential in early studies but require further research for definitive conclusions.

What other types of research exist?

Promising alternatives to phytochemicals from black raspberries for prostate cancer patients include: 1) Green and black tea, which have shown chemopreventive effects in prostate cancer. 2) Saw palmetto, which has been studied for its effects on lower urinary tract symptoms and benign prostate hyperplasia, though it has some associated risks. 3) NSAIDs, including aspirin, which have shown potential in cancer prevention, though they come with cardiovascular risks. Patients should discuss these options with their healthcare provider to determine the best course of action based on their individual health profile.

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Phytochemical

Black Raspberry Products for Prostate Cancer

Phase 1

Waitlist Available

Led By Steven Clinton

Research Sponsored by Ohio State University Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have biopsy proven carcinoma of the prostate

Have liver enzymes within normal limits

Must not have

Have significant loss of gastrointestinal organs due to surgery, except for appendix

Have difficulty swallowing (dysphagia), pain with swallowing (odynophagia), salivary gland dysfunction, or xerostomia (dry mouth)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 weeks

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this study focuses on dietary intervention rather than medication or invasive procedures, side effects may be minimal but could include potential allergic reactions or gastrointestinal discomfort from the black raspberry products.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with prostate cancer through a biopsy.

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My liver function tests are normal.

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I am not currently on hormone or chemotherapy as part of another clinical trial.

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I am fully active or can carry out light work.

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I agree to follow a specific vitamin and mineral plan and not take other supplements during the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had surgery that removed significant parts of my digestive system, except for my appendix.

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

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I have undergone castration due to surgery or an injury.

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I take hormone supplements for a pituitary or other hormone disorder, but not for diabetes or osteoporosis.

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I do not have conditions like Crohn's, Celiac, IBS, kidney or liver issues, extreme weight loss, or short bowel syndrome.

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I have a condition that affects my immune system, like an autoimmune disorder or cancer.

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I have long-lasting sores or a history of oral cavity issues.

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I am currently using blood thinners or prescribed mouthwash.

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I am being treated for a cancer other than prostate cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Compliance determined by consumption of at least 80% of black raspberries (BRB) and positive tests for urinary berry metabolites

Secondary study objectives

Black Raspberry metabolites levels in the prostate tissue removed at surgery

Changes in PSA or PSA doubling time

Presence of black raspberry metabolites in the urine collected 24 hours before surgery

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

7Treatment groups

Experimental Treatment

Active Control

Group I: Arm VII (higher-dose black raspberry confection)Experimental Treatment5 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 Treatment5 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 Treatment5 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 Treatment5 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 Control4 Interventions

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

Group VI: Arm I (regular diet)Active Control3 Interventions

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

Group VII: Arm II (low polyphenol diet)Active Control4 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

dietary intervention

2000

Completed Phase 2

~600

quality-of-life assessment

2012

Completed Phase 3

~2780

0 / 14Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for prostate cancer include surgery (removal of the prostate gland), radiation therapy (using high-energy rays to kill cancer cells), hormone therapy (blocking or lowering testosterone to slow cancer growth), chemotherapy (using drugs to kill rapidly dividing cells), and newer treatments like immunotherapy (stimulating the immune system to attack cancer cells) and targeted therapy (targeting specific molecules involved in cancer growth). These treatments are crucial for managing prostate cancer by either removing or reducing the tumor burden, slowing disease progression, or alleviating symptoms. The study of phytochemicals from black raspberries is relevant as these compounds may offer chemopreventive benefits by potentially inhibiting cancer cell growth and metastasis, providing a complementary approach to traditional treatments.

Investigating the effects of lycopene and green tea on the metabolome of men at risk of prostate cancer: The ProDiet randomised controlled trial.