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:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07462403
Eligibility Criteria:
Inclusion Criteria:
* Individuals must meet all of the following inclusion criteria in order to be eligible to participate in the study:
* Must be 18 years of age or older
* Provide signed and dated informed consent form
* Had a histological diagnosis of PCa (Stage IIA-IVB)
* Are beginning or receiving ADT (including medical castration with LHRH-agonist-antagonist androgen receptor modulators) for PCa with an anticipated duration of ≥ 3 months. The ADT is defined as: (a) Gonadotropin Releasing Hormone (GNRH) agonist (including leuprolide \[Lupron/Eligard\], goserelin \[Zoladex\], triptorelin \[Trelstar\], histrelin \[Vantas\], and abiraterone \[Zytiga\]) alone; (b) GNRH agonist with oral androgen receptor blockade (including bicalutamide \[Casodex\], flutamide \[Eulexin\], and enzalutamide \[Xtandi\]), and (c) GNRH agonist, oral androgen receptor blockade, and 5-alpha reductase inhibitors. Patients on androgen receptor modulators and second-generation androgen receptor antagonists will qualify.
* Intermittent ADT will be allowed as long as the overall duration is more than 3 months.
* BMI ≥25 kg/m2
* Radiation therapy will be allowed concurrently.
* Willing and able to comply with the protocol for the duration of the study
* Able to speak, read and write English
* Has a mobile phone with TXT capability.
Exclusion Criteria:
* An individual who meets any of the following criteria will be excluded from participation in this study:
* Inability to tolerate a normal diet (may include an active malabsorption syndrome at time of consent (i.e. Crohn's disease, major bowel resection leading to permanent malabsorption)
* Patients on concurrent chemotherapy will be excluded.
* ECOG score \> 2
* Medications such as finasteride/dutasteride/saw palmetto are not allowed.
* Insulin injection or glyburide medication
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT07462403
Study Brief:
Protocol Section:
NCT07462403