Intermittent Fasting in Prostate Cancer Patients Receiving Androgen Deprivation Therapy

Launched by STATE UNIVERSITY OF NEW YORK AT BUFFALO · Dec 14, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how intermittent fasting, which involves reducing calorie intake at certain times, may affect prostate cancer patients who are receiving androgen deprivation therapy (a treatment that lowers male hormones to slow cancer growth). The study aims to see if this approach, potentially combined with a diet rich in plants, is practical and acceptable for participants. Researchers will track how many people join the study, how many drop out, and how well participants stick to the diet based on their own reports.

To take part in this trial, participants must be males aged 18 or older with measurable prostate cancer who can give consent and have a good performance status, meaning they are generally well enough to participate. They should also have a life expectancy of at least six months. Throughout the study, participants can expect regular check-ins and support as they follow the fasting and diet guidelines. It's important to note that individuals with certain health issues or those currently involved in other studies may not be eligible to join.

Gender

MALE

Eligibility 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.