Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT03679260
Eligibility Criteria:
Inclusion Criteria:
* Pathologically confirmed prostate adenocarcinoma
* Most recent biopsy positive for prostate cancer
* Currently on or starting active surveillance
* Ability to read, write, and understand English
* BMI \>24 kg/m2
* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
* Scheduled to undergo a prostate biopsy in 6 months as part of standard of care for their prostate cancer
* Age \> 18 years
Exclusion Criteria:
* Already consuming a severely carbohydrate-restricted (i.e. \<20g total carbohydrates per day) or vegetarian diet
* Medical comorbidities that in the opinion of the investigator limits the patient's ability to complete this study
* Anticipate needing prostate cancer therapy within the next 12 months (i.e. surgery, radiation, or hormonal therapy)
* Loss of \>10% of body weight within the previous 6 months
* Currently receiving any oral hormonal therapy for prostate cancer or BPH (finasteride, dutasteride, bicalutamide)
* If prior oral hormonal therapy use for prostate cancer or BPH (as defined above), must not have been taking at time of prior biopsy and must be off for at least 3 months prior to study enrollment (oral medications)
* Having ever received any injection hormonal therapy or investigational vaccine for prostate cancer (LHRH agonist, LHRH antagonists, ProstVax, Provenge)
* Current use of weight loss medications including herbal weight loss supplements or enrolled in a diet/weight loss program
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT03679260
Study Brief:
Protocol Section:
NCT03679260