Prostate CancerNCT06172283
Intermittent Fasting in Prostate Cancer Patients Receiving Androgen Deprivation Therapy
A study testing Intermittent Fasting in people with Prostate Cancer, run by State University of New York at Buffalo at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Intermittent Fasting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2023to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University at Buffalo/Great Lakes Cancer Center
Buffalo, New York, 14203
Roberto Pili, 716-881-8918, rpili@buffalo.edu
About this study
Official title: A Pilot, Feasibility Study of Intermittent Fasting in Prostate Cancer Patients Receiving Androgen Deprivation Therapy
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.
- Conditions
- Prostate Cancer
- Being tested
- Intermittent Fasting
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent FastingOther
Dietary intervention
| Study group | Role | What they receive |
|---|---|---|
| Intermittent Fasting | Experimental | Patients will undergo 16h periods of fasting everyday. Optionally, patients will be offered to undergo a plant-based diet consisting of 20% plant based protein, 50% carbohydrates, and 30% fat for the duration of the study. Receives: Other: Intermittent Fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment rate
Feasibility of intermittent fasting (with the option of a plant-enriched diet) in prostate cancer patients receiving androgen deprivation therapy
Measured: 3 years
Drop-out rate
Feasibility of intermittent fasting (with the option of a plant-enriched diet) in prostate cancer patients receiving androgen deprivation therapy
Measured: 3 years
Secondary outcomes (2)
Number of patients who achieve either partial or complete response by RECIST criteria on tumor imaging.
Clinical efficacy of the combination of intermittent fasting with or without a plant-enriched diet plus androgen deprivation therapy
Measured: 3 years
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
Safety, tolerability and reduction of common toxicities of the combination of intermittent fasting and the option of a plant-enriched diet intervention as compared to historical data.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start5 Dec 2023
- Primary completion1 Jan 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Longitudinal
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Pili, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06172283
- Sponsor's protocol ID
- STUDY00007635
- Status last verified
- Apr 2026
- First submitted
- 7 Dec 2023
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot, Feasibility Study of Intermittent Fasting in Prostate Cancer Patients Receiving Androgen Deprivation Therapy
- ClinicalTrials.gov ID
- NCT06172283
- Acronym / sponsor ID
- STUDY00007635
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 5 Dec 2023 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 15 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Longitudinal
| Arm | Type | Receives |
|---|---|---|
| Intermittent Fasting | Experimental | Other: Intermittent FastingPatients will undergo 16h periods of fasting everyday. Optionally, patients will be offered to undergo a plant-based diet consisting of 20% plant based protein, 50% carbohydrates, and 30% fat for the duration of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent FastingDietary intervention | Other | Intermittent Fasting |
Primary outcome
Enrollment rate
Time frame: 3 years
Feasibility of intermittent fasting (with the option of a plant-enriched diet) in prostate cancer patients receiving androgen deprivation therapy
Drop-out rate
Time frame: 3 years
Feasibility of intermittent fasting (with the option of a plant-enriched diet) in prostate cancer patients receiving androgen deprivation therapy
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Fasting in people with Prostate Cancer, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roberto Pili, MD (716-881-8918, rpili@buffalo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment rate (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.