NCT05764330Completed
Weight Loss Interventions to Reduce Cancer Progression in Prostate Cancer Patients Under Active Surveillance
Source: ClinicalTrials.gov · Last updated 6 Aug 2025
Brief summary (registry, in English)
This clinical trial examines weight loss interventions in reducing cancer progression in prostate cancer patients under active surveillance. Intensive lifestyle interventions that recommend modest reductions in daily caloric intake (i.e. continuous calorie energy reduction \[CER\]) are the gold-standard for weight loss, and have been tested in cancer survivors, including prostate cancer patients. However, few interventions have been developed for low-risk prostate cancer patients on active surveillance. Intermittent fasting (IF) may be superior to CER in the context of prostate cancer progression given its dual role in weight loss and metabolic switching from the use of glucose as a fuel source to the use of fatty acids and ketone bodies. This study may help researchers determine which weight loss strategies can reduce their risk of prostate cancer recurrence, and other negative health effects of being overweight or obese.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 21 Feb 2023
- Start date
- Apr 2024
- Primary completion date
- Jun 2025
- Lead sponsor
- Roswell Park Cancer Institute
- Diseases
- Prostate cancer
- NCT number
- NCT05764330
What you commit to
- Study type: Interventional
- Participants enrolled: 20
- From Apr 2024 to the primary completion date, Jun 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.
Other illness
- History of partial or radical prostatectomy
Lab values
- Adults who have had a myocardial infarction (heart attack) or stroke without medical clearance from their primary care physician to participate in the study
- Adults who currently have type 1 or type 2 diabetes without medical clearance from their primary care physician to participate in the study
Other
- Unable to consent
- Unwilling or unable to follow protocol requirements
- Unable to complete study measures in English
Who the study is looking for
- Age 18 years old or older (no upper limit)
- Body mass index (BMI) \>= 25 kg/m\^2
- English speaking
- Not currently on weight loss medications
- Prostate cancer patients who are under active surveillance (including observation) and actively followed at Roswell Park
- Not under active treatment for other cancer diagnosis
- Free of medical problems that might contraindicate participation in a behavioral weight reduction program containing an exercise component
- Has not lost at least 10% of their body weight in the last 6 months
- Has not had bariatric surgery in the last 10 years
- Able to walk unassisted and continuously for 10 minutes
- Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
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 |
|---|---|---|---|
| Roswell Park Cancer Institute Coordinator of this site? Confirm its status | Buffalo | United States | Unknown status |
Related publications
- Intermittent fasting versus continuous calorie energy reduction in prostate cancer patients on active surveillance.Transl Behav Med · 2026 · PMID 42816069
This page is information, not medical advice. Discuss any trial with your doctor.