Intermittent fasting for prostate cancer patients on hormone therapy
A Pilot, Feasibility Study of Intermittent Fasting in Prostate Cancer Patients Receiving Androgen Deprivation Therapy
This study tests if intermittent fasting and a plant-based diet can be safely followed by men with prostate cancer who are on hormone therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | State University of New York at Buffalo Academic / other |
| Locations | 1 site (Buffalo, New York) |
| Trial ID | NCT06172283 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the feasibility of intermittent caloric restriction, potentially combined with a plant-enriched diet, in men with prostate cancer undergoing androgen deprivation therapy. The study will measure enrollment and drop-out rates, as well as compliance with the dietary regimen through self-reports. The aim is to determine whether this dietary approach can be effectively implemented in this patient population.
Who should consider this trial
Good fit: Ideal candidates are males aged 18 and older with measurable prostate cancer who are eligible for androgen deprivation therapy.
Not a fit: Patients with an ECOG performance status of 2 or higher or those currently participating in other investigational studies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve the management of prostate cancer and enhance the quality of life for patients undergoing hormone therapy.
How similar studies have performed: While intermittent fasting has been explored in various contexts, this specific approach in prostate cancer patients undergoing hormone therapy is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * In order to be eligible for participation in this trial, the subject must: * Be willing and able to provide written informed consent for the trial. * Be male at birth and least 18 years of age on day of signing informed consent. * Have measurable prostate cancer disease and be eligible for androgen deprivation therapy. * Have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale. * Demonstrate adequate organ function (all screening labs should be performed within 10 days of treatment initiation). * Subjects have archival tumor tissue available or are willing to undergo a baseline biopsy prior to treatment. * Subjects must have a life expectancy of at least 6 months. Exclusion Criteria: * Has an ECOG performance of 2 or higher. * Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the beginning of the treatment. * Has a known additional malignancy that is progressing or requires active treatment. * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. * Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. * Has a known allergy, intolerance, or medical contraindication to receiving the contrast dye required for the protocol-specified CT/MRI imaging * Has any other medical intervention or condition which, in the opinion of the Principal Investigator, could compromise adherence with study requirements or otherwise compromise the study's objectives. * Is not willing and able to provide written informed consent for the trial.
Where this trial is running
Buffalo, New York
- University at Buffalo/Great Lakes Cancer Center — Buffalo, New York, United States (Recruiting)
Study contacts
- Study coordinator: Roberto Pili, MD
- Email: rpili@buffalo.edu
- Phone: 716-881-8918
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.