AzTrials
AzTrials

Prostate CarcinomaNCT05764330

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

A study testing Biospecimen Collection, Dietary Intervention and Fasting in people with Prostate Carcinoma, run by Roswell Park Cancer Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Carcinoma
What is being tested?
Biospecimen Collection, Dietary Intervention and Fasting
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
24 Apr 2024to 30 Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

Other trials in United States

About this study

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Develop two evidence-based behavioral weight loss intervention programs (IF and CER) with a goal to cause weight loss in prostate cancer (PCa) patients on active surveillance (AS).

II. Determine the initial comparative effectiveness of two intervention programs (IF and CER) on weight loss and PCa progression outcomes.

SECONDARY OBJECTIVE:

  1. Compare the effects of the interventions on biomarkers underlying obesity and PCa to provide mechanistic insights and potential surrogate biomarkers for PCa prognosis.

OUTLINE: Patients are randomized to 1 of 2 arms.

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

ARM II: 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 fasting. Patients will undergo fasting 2 days per week and eat according to the National Cancer Institute (NCI) guidelines the remaining 5 days. Patients also undergo collection of blood samples throughout the trial.

Being tested
Biospecimen Collection, Dietary Intervention, Fasting
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo collection of blood samples

  • Dietary InterventionOther

    Also called Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions

    Undergo CER intervention

  • Dietary InterventionOther

    Also called Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions

    Undergo IF intervention

  • FastingBehavioural

    Also called Fast

    Undergo fasting

Study groups in NCT05764330
Study groupRoleWhat they receive
Arm I (CER)Active comparatorPatients 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.
Receives: Procedure: Biospecimen Collection; Other: Dietary Intervention
Arm II (IF)ExperimentalPatients 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.
Receives: Procedure: Biospecimen Collection; Other: Dietary Intervention; Behavioral: Fasting

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Body weight

    Weight will be measured using a body composition monitor.

    Measured: Up to 6 months

  2. 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.

    Measured: Up to 6 months

Secondary outcomes (6)

  1. Dietary intake

    Will confirm the extent changes in body weight are due to changes in caloric intake. Dietary intake will be assessed by the interview administered Nutrition Data System for Research.

    Measured: Up to 6 months

  2. Physical activity

    Will be assessed using the Paffenbarger Physical Activity Questionnaire (PAQ). The PAQ provides an estimate of calories expended per week in overall leisure time activity and in activities of light (5 kcal/min), medium (7.5 kcal/min) and high (19 kcal/min) intensity.

    Measured: Up to 6 months

  3. Change from baseline in Prostate Cancer related biomarkers

    Correlation of weight loss and PCa biomarkers.

    Measured: Up to 6 months

  4. Change in Urinary functions

    urinary function changes will be tracked using a validated questionnaire, the International Prostate Symptom Score

    Measured: Up to 6 months

  5. Improvement of Quality of life

    Self-reported outcomes routinely collected at each follow up clinic visit using validated questionnaire - UCLA PCI for quality of life.The UCLA PCI domain is scored on a scale of 0-100 points with higher values representing better outcomes.

    Measured: Up to 6 months

  6. Change in Sexual functions

    Sexual health inventory for men (SHIM). The total score is obtained by adding all five item scores, and can range from 5 to 25. Higher scores indicate higher level of sexual function and less erectile dysfunction.

    Measured: Up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2023
  2. Study start24 Apr 2024
  3. Primary completion6 Jun 2025
  4. Study completion30 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05764330
Sponsor's protocol ID
I-2980822
Other IDs
NCI-2023-01092, I-2980822
Status last verified
Aug 2025
First submitted
21 Feb 2023
Last updated
6 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Yeary KHK, Yu H, Hussein AA, Varady K, DiCarlo E, Escaldi A, Tang L. Intermittent fasting versus continuous calorie energy reduction in prostate cancer patients on active surveillance. Transl Behav Med. 2026 Jan 7;16(1):ibag069. doi: 10.1093/tbm/ibag069.

    PubMed 42816069

Questions about this trial

What is this clinical trial studying?

A study testing Biospecimen Collection, Dietary Intervention and Fasting in people with Prostate Carcinoma, run by Roswell Park Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Body weight (time frame: Up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05764330, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in