NCT07462403Completed
A Prolonged Nightly Fasting for Men on ADT for PCa
A Prolonged Nightly Fasting Plus Telehealth Coaching Intervention (PNF+) for Men on Androgen Deprivation Therapy for PCa: A Pilot Feasibility Randomized Controlled
Source: ClinicalTrials.gov · Last updated 2 Oct 2026
Brief summary (registry, in English)
This small study tested a 3-month text-based health coaching program for men with prostate cancer on hormone therapy. The program was feasible and well accepted, with participants showing good engagement and some improvements in weight and quality of life. However, differences between groups were not statistically significant, so larger studies are needed to confirm the benefits.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 4 Mar 2026
- Start date
- 2 May 2024
- Primary completion date
- 2 May 2025
- Lead sponsor
- Thomas Jefferson University
- Diseases
- Prostate cancer
- NCT number
- NCT07462403
What you commit to
- Study type: Interventional
- Participants enrolled: 40
- From 2 May 2024 to the primary completion date, 2 May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Thomas Jefferson University Hospital Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.