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New treatment option for Prostate Cancer
Official title Intermittent Fasting in Prostate Cancer Patients Receiving Androgen Deprivation Therapy
ClinicalTrials.gov ID: NCT06172283
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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.
You likely can't join if
- 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...
- 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...
- 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
See the full eligibility 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).
- people have archival tumor tissue available or are willing to undergo a baseline biopsy prior to treatment.
- people must have a life expectancy of at least 6 months.
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Buffalo, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Buffalo, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.