Black raspberries under the microscope for prostate cancer prevention
NCT ID NCT01823562
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial studied how compounds from black raspberries are absorbed and processed in 60 men with prostate cancer who were scheduled for surgery. Participants ate a black raspberry confection and followed a special diet before surgery. The goal was not to treat cancer but to gather information that could guide future research on dietary prevention. No side effects were reported.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- black raspberry confection
- What this could lead to
- If successful, this could help design future studies on whether black raspberries might help prevent prostate cancer.
- What could go wrong
- This is a very early phase 1 trial focused on absorption and safety, not on treating or preventing cancer. It does not test whether black raspberries actually affect cancer outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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60 people
The number who actually took part.
- Started
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Oct 2012
- Finished
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Nov 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Have biopsy proven carcinoma of the prostate * Have chosen a radical prostatectomy for treatment of their disease after the medical team has presented all possible treatment options * Not be receiving neoadjuvant hormonal or chemotherapy (other clinical trials) * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * Not currently taking berry dietary supplements, or "alternative" products (Acai berry, pomegranate, black raspberry, Optiberry, Juice Plus) * Have BUN/Cr (blood urea nitrogen and serum creatinine) within normal limits * Have liver enzymes within normal limits * Have complete blood count (CBC) within normal limits * Have prothrombin time/partial thromboplastin time (PT/PTT/INR) within normal limits * Voluntarily agree to participate and sign an informed consent document * Agree to have prostate biopsy blocks provided to the study for evaluation * Agree to consume a standardized vitamin and mineral supplement and avoid other nutrition, dietary, or alternative medications/supplements for the duration of the study * Agree to follow a controlled polyphenolic and/ or ellagitannin diet Exclusion Criteria: * Have an active malignancy other than prostate cancer that requires therapy * Have a prostate biopsy with less than 5% cancer involvement * Have a history of traumatic or surgical castration * Have a history of pituitary hormone diseases that currently require supplemental hormonal administration (thyroid hormones, adrenocorticotropic hormone \[ACTH\], growth hormone) or other endocrine disorders requiring hormone administration with the exception of diabetes and osteoporosis * Are taking certain medications; no concurrent finasteride (Proscar) or other hormonal agents for chemoprevention/treatment of benign prostate hyperplasia (BPH); utilizing prescription medications for urinary outlet obstructive symptoms will not be permitted; the use of non-prescription substances to improve urinary tract symptoms will not be permitted (i.e. Saw Palmetto, other herbal, alternative products) * Have a known allergy to black raspberries, corn, and wheat products or those who have never consumed any of these products * Have active metabolic or digestive illnesses such as malabsorptive disorders (Crohn's, Celiac disease, irritable bowel syndrome \[IBS\]), renal insufficiency, hepatic insufficiency, cachexia, or short bowel syndrome * Have significant loss of gastrointestinal organs due to surgery, except for appendix * Have altered immunity such as autoimmune disorders, cancer, anemia, hemophilia, and blood dyscrasias * Have noticeable open lesions in the oral cavity, sores that have not healed for more than 2 months or have a history of leukoplakia, tumors of the buccal cavity, throat, and lips * Have difficulty swallowing (dysphagia), pain with swallowing (odynophagia), salivary gland dysfunction, or xerostomia (dry mouth) * Are taking medications that inhibit clotting (warfarin sodium) or using prescribed oral rinses (Peridex)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, 43210, United States
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Other studies related to the condition(s) this trial covers.
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