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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06172283
Other study ID # STUDY00007635
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 5, 2023
Est. completion date December 31, 2028

Study information

Verified date December 2023
Source State University of New York at Buffalo
Contact Roberto Pili, MD
Phone 716-881-8918
Email rpili@buffalo.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 31, 2028
Est. primary completion date January 1, 2027
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Intermittent Fasting
Dietary intervention

Locations

Country Name City State
United States University at Buffalo/Great Lakes Cancer Center Buffalo New York

Sponsors (1)

Lead Sponsor Collaborator
State University of New York at Buffalo

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Enrollment rate Feasibility of intermittent fasting (with the option of a plant-enriched diet) in prostate cancer patients receiving androgen deprivation therapy 3 years
Primary Drop-out rate Feasibility of intermittent fasting (with the option of a plant-enriched diet) in prostate cancer patients receiving androgen deprivation therapy 3 years
Secondary 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 3 years
Secondary 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. 3 years
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