Aborption and Metabolism of Lyophilized Black Raspberry Food Products in Men With Prostate Cancer… (NCT01823562) | Clinical Trial Compass
CompletedPhase 1
Aborption and Metabolism of Lyophilized Black Raspberry Food Products in Men With Prostate Cancer Undergoing Surgery
United States60 participantsStarted 2012-10-17
Plain-language summary
This Phase I/Ib trial is studying the absorption and metabolism of phytochemicals found in black raspberries in men undergoing surgery for prostate cancer. This knowledge will help us design future chemoprevention studies and assist in making future dietary recommendations for men at high risk for prostate cancer.
Who can participate
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, adren…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Adverse Events Assessed Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Timeframe: Up to 30 days after completion of study treatment
2
Percentage of Intervention Consumed
Timeframe: Up to 6-weeks
Trial details
NCT IDNCT01823562
SponsorOhio State University Comprehensive Cancer Center