Weight Loss Interventions to Reduce Cancer Progression in Prostate Cancer Patients Under Active Surveillance

NCT05764330 | Completed

• 2 other identifiers: I-2980822NCI-2023-01092
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Carcinoma

Outcome Measures

Primary Outcomes (2)

• Change in Body weight

  Weight will be measured using a body composition monitor.

  Up to 6 months

• Changes in prostate cancer (PCa) progression

  Will assess changes in PCa progression indicated by serum prostate specific antigen (PSA) doubling time, and biopsy tumor upgrading and/or upstaging if required clinically, between the timepoints prior and post to the intervention. The timing of the intervention and data collection visits will be scheduled to correspond with the PCa patient's regular management check-up with their physician to allow their scheduled PSA test fall within at least a 6-month time window. For patients if prostate biopsy per clinical guidance is scheduled within 6 months after the intervention, the results from the biopsy post to the intervention as well as the nearest biopsy prior to the intervention will be requested. PSA test results (level and doubling time) and pathology reports on biopsies tissues (stage and grade) will be requested from the Biomedical Research Informatics Shared Resource for both baseline and follow-up visits and defined based on clinical criteria.

  Up to 6 months

Secondary Outcomes (6)

• Dietary intake

  Up to 6 months

• Physical activity

  Up to 6 months

• Change from baseline in Prostate Cancer related biomarkers

  Up to 6 months

• Change in Urinary functions

  Up to 6 months

• Improvement of Quality of life

  Up to 6 months

Study Arms (2)

Arm I (CER)

ACTIVE COMPARATOR

Patients undergo CER intervention consisting of remote lesson containing information and behavioral strategies about weight loss, session with study interventionist to review lessons, and self-monitoring of body weight. Patients also undergo collection of blood samples throughout the trial.

Procedure: Biospecimen Collection; Other: Dietary Intervention

Arm II (IF)

EXPERIMENTAL

Patients undergo IF intervention consisting of remote lesson containing information and behavioral strategies about fasting, session with study interventionist to review lessons, and self-monitoring of body weight. Patients also undergo fasting 2 days per week and eat according to the NCI guidelines the remaining 5 days. Patients also undergo collection of blood samples throughout the trial.

Procedure: Biospecimen Collection; Other: Dietary Intervention; Behavioral: Fasting

Interventions

Biospecimen Collection PROCEDURE

Undergo collection of blood samples

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Arm I (CER); Arm II (IF)

Dietary Intervention OTHER

Undergo CER intervention

Also known as: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions, Nutritional Interventions

Arm I (CER)

Fasting BEHAVIORAL

Undergo fasting

Also known as: Fast

Arm II (IF)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unable to consent
• Unwilling or unable to follow protocol requirements
• Unable to complete study measures in English
• 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
• History of partial or radical prostatectomy

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Specimen Handling; Diet Therapy; Angptl4 protein, mouse

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Nutrition Therapy; Therapeutics

Study Officials

• Karen Yeary

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: March 10, 2023
• Study Start: April 24, 2024
• Primary Completion: June 6, 2025
• Study Completion: June 30, 2025
• Last Updated: August 6, 2025

Record last verified: 2025-08

Locations

US (1)