Status:
RECRUITING
Intermittent Fasting in Prostate Cancer Patients Receiving Androgen Deprivation Therapy
Lead Sponsor:
State University of New York at Buffalo
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
This is a a pilot study to assess the feasibility of intermittent caloric restriction (plus a plant-enriched diet optionally) in prostate cancer patients receiving androgen deprivation therapy. Study ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06172283
Start Date
December 5 2023
End Date
December 31 2028
Last Update
February 17 2025
Active Locations (1)
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1
University at Buffalo/Great Lakes Cancer Center
Buffalo, New York, United States, 14203