Clinical trial NCT06172283: Intermittent Fasting in Prostate Cancer Patients Receiving Androgen Deprivation Therapy
Official title: A Pilot, Feasibility Study of Intermittent Fasting in Prostate Cancer Patients Receiving Androgen Deprivation Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2023-12-15
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Longitudinal
Primary purpose: TREATMENT

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 feasibility measures will include enrollment rate, drop-out rate and compliance with diet measured by self-reports.


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.

Primary outcomes:
measure: Enrollment rate
timeFrame: 3 years
measure: Drop-out rate
timeFrame: 3 years
Secondary outcomes:
measure: Number of patients who achieve either partial or complete response by RECIST criteria on tumor imaging.
timeFrame: 3 years
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
timeFrame: 3 years
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: University at Buffalo/Great Lakes Cancer Center
state: New York
Study officials:
References: