Recruiting NCT06172283
Intermittent Fasting in Prostate Cancer Patients Receiving Androgen Deprivation Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intermittent Fasting.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Pilot, Feasibility Study of Intermittent Fasting in Prostate Cancer Patients Receiving Androgen Deprivation Therapy
Overview
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.
Interventions
- Other Intermittent Fasting
Dietary intervention
Primary outcome measures
- Enrollment rate [Time frame: 3 years]
- Drop-out rate [Time frame: 3 years]
Secondary outcome measures (2)
- Number of patients who achieve either partial or complete response by RECIST criteria on tumor imaging. [Time frame: 3 years]
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0. [Time frame: 3 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University at Buffalo/Great Lakes Cancer Center — Buffalo
Identifiers
NCT: NCT06172283 · STUDY00007635