Prostate AdenocarcinomaPhase 2NCT05832086
Intermittent Fasting Using a Fasting-Mimicking Diet to Improve Prostate Cancer Control and Metabolic Outcomes
A Phase 2 study testing Fasting Mimicking Diet (FMD) and Standard Anti-Cancer Diet in people with Prostate Adenocarcinoma, run by Stephen Freedland at 3 sites in United States.
Trial summary
This is a Phase 2, randomized two-armed, multi-site study of 138 patients with metastatic castrate sensitive prostate adenocarcinoma. Patients will be randomized 1:1 to receive the fasting mimicking diet, or usual diet. All patients will receive standard of care treatment for their prostate cancer. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Adenocarcinoma
- What is being tested?
- Fasting Mimicking Diet (FMD) and Standard Anti-Cancer Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 138 participants
- Where
- 3 sitesUnited States
- Study dates
- 13 Sep 2023to 30 Mar 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Metastatic castrate sensitive prostate adenocarcinoma (Adenocarcinoma prostate histologically confirmed by biopsy AND Metastatic disease confirmed biopsy, or MRI scan)
- Men receiving or planning to start first-line intensified ADT (within 30 days of registration) with abiraterone, apalutamide, enzalutamide, or darolutamide with or without current or prior chemotherapy
- Reads, writes, and understands English or Spanish and has telephone access for remote contact with the study dietitian.
- Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
Who cannot join
- Allergies to any ingredients listed on the Xentigen Ingredient List
- Men with diabetes who are not on stable doses of antihyperglycemic medication for at least 6 months and without physician consent that they may safely hold antihyperglycemic medication during the 5 days of FMD
- Regularly practicing a fasting diet that in the opinion of the study physician would impact study participation
- Significant co-morbidities (i.e., cardiac, pulmonary, liver disease, ongoing alcohol/drug abuse) that in the opinion of the study physician would preclude enrollment in this study.
- Body Mass Index (BMI) <20kg/m2
- Men actively trying to lose weight OR on weight loss medications (including but not limited to Contrave, Saxenda, Xenical) or planning to receive weight loss surgery in the next six months
- Self-reported weight loss ≥ 10% in the last 6 months
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Beckman Research Institute of the City of Hope
Duarte, California, 91010
Tanya Dorff, MD, (626) 256-4673, tdorff@coh.or
- Recruiting
Duke University
Durham, North Carolina, 27710
Pao-Hwa Lin, PhD, (919) 660-6685, lin00004@mc.duke.edu
Daniel George, MD
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Stephen Freedland, MD, 310-423-5842, Stephen.Freedland@csmc.edu
Gillian Gresham, PhD
About this study
This is a Phase 2, randomized two-armed, multi-site study of 138 patients with metastatic castrate sensitive prostate adenocarcinoma. Patients will be randomized 1:1 to receive the fasting mimicking diet, or usual diet. All patients will receive standard of care treatment for their prostate cancer. The fasting mimicking diet will be consumed for 5 days per month for a total of 6 months and will be monitored by trained research dietitians.
This study aims to examine the effects of a fasting mimicking diet (5 days per month eating L-Nutra products only for 6 months) vs. usual diet on response to cancer treatment of metastatic castrate sensitive prostate adenocarcinoma.
- Conditions
- Prostate Adenocarcinoma
- Being tested
- Fasting Mimicking Diet (FMD), Standard Anti-Cancer Diet
- Keywords
- Fasting
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fasting Mimicking Diet (FMD)Behavioural
Consume the FMD (Xentigen, L-Nutra, Los Angeles, CA) for 5 days every monthly cycle for 6 cycles total in 6 months.
Standard Anti-Cancer DietBehavioural
Will receive standard of care diet and exercise recommendations from the study dietitian. The diet advice will be consistent with the American Cancer Society for cancer survivors and exercise recommendation of a goal of 150 minutes/week of cardiovascular exercise and weight resistance training at least twice a week.
| Study group | Role | What they receive |
|---|---|---|
| Fasting Mimicking Diet | Experimental | Intermittent fasting using a fasting mimicking diet Receives: Behavioral: Fasting Mimicking Diet (FMD) |
| Standard Anti-Cancer Diet | Placebo comparator | Standard Anti-Cancer Diet Receives: Behavioral: Standard Anti-Cancer Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to cancer treatment
Will be measured by the proportion of patients who achieved PSA nadir ≤0.2 ng/dL at any time point within the 6-month study and absolute PSA nadir.
Measured: 6 Month visit
Secondary outcomes (8)
Castration resistance 1
will be measured by Testosterone (ng/dl)
Measured: 6 Month visit
Castration resistance 2
will be measured by PSA levels (ng/mL)
Measured: 6 Month visit
Metabolic Toxicity 1
Will be measured by the changes in HbA1c
Measured: Change from Baseline to 6 Month visit
Metabolic Toxicity 2
Will be measured by the changes in waist circumference
Measured: Change from Baseline to 6 Month visit
Metabolic Toxicity 3
Will be measured by the changes in fat mass (assessed via bioelectrical expedience)
Measured: Change from Baseline to 6 Month visit
Metabolic Toxicity 4
Will be measured by the changes in body weight
Measured: Change from Baseline to 6 Month visit
Self-reported overall well-being
will be measured in changes in the scores calculated from the Medical Outcomes Study Short Form Health Survey (SF-12) questionnaire. Scores can range from 12-56 with a higher score indicating a better outcome.
Measured: Change from Baseline to 6 Month visit
Self-reported energy levels
will be measured in changes in the scores calculated from the Godin leisure-time physical activity questionnaire. Scores can range from 0 and above, with a higher score indicating a better physical activity outcome.
Measured: Change from Baseline to 6 Month visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start13 Sep 2023
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stephen Freedland
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Stephen Freedland, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05832086
- Sponsor's protocol ID
- IIT2023-02-FREEDLAND-FAST-PRO
- Other IDs
- 1R01CA280081-01
- Status last verified
- Aug 2026
- First submitted
- 3 Apr 2023
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Fasting Using a Fasting-Mimicking Diet to Improve Prostate Cancer Control and Metabolic Outcomes
- ClinicalTrials.gov ID
- NCT05832086
- Acronym / sponsor ID
- IIT2023-02-FREEDLAND-FAST-PRO
- Conditions
- Prostate Adenocarcinoma
- Keywords
- Fasting
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Stephen FreedlandUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 13 Sep 2023 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Mar 2029 (estimated)
- First posted
- 27 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 2, randomized two-armed, multi-site study of 138 patients with metastatic castrate sensitive prostate adenocarcinoma. Patients will be randomized 1:1 to receive the fasting mimicking diet, or usual diet. All patients will receive standard of care treatment for their prostate cancer. The fasting mimicking diet will be consumed for 5 days per month for a total of 6 months and will be monitored by trained research dietitians.
This study aims to examine the effects of a fasting mimicking diet (5 days per month eating L-Nutra products only for 6 months) vs. usual diet on response to cancer treatment of metastatic castrate sensitive prostate adenocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fasting Mimicking Diet | Experimental | Behavioral: Fasting Mimicking Diet (FMD)Intermittent fasting using a fasting mimicking diet |
| Standard Anti-Cancer Diet | Placebo comparator | Behavioral: Standard Anti-Cancer DietStandard Anti-Cancer Diet |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Metastatic castrate sensitive prostate adenocarcinoma (Adenocarcinoma prostate histologically confirmed by biopsy AND Metastatic disease confirmed biopsy, or MRI scan)
- Men receiving or planning to start first-line intensified ADT (within 30 days of registration) with abiraterone, apalutamide, enzalutamide, or darolutamide with or without current or prior chemotherapy
- Reads, writes, and understands English or Spanish and has telephone access for remote contact with the study dietitian.
- Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
Key exclusion criteria (7 listed)
- Allergies to any ingredients listed on the Xentigen Ingredient List
- Men with diabetes who are not on stable doses of antihyperglycemic medication for at least 6 months and without physician consent that they may safely hold antihyperglycemic medication during the 5 days of FMD
- Regularly practicing a fasting diet that in the opinion of the study physician would impact study participation
- Significant co-morbidities (i.e., cardiac, pulmonary, liver disease, ongoing alcohol/drug abuse) that in the opinion of the study physician would preclude enrollment in this study.
- Body Mass Index (BMI) <20kg/m2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fasting Mimicking Diet (FMD)Consume the FMD (Xentigen, L-Nutra, Los Angeles, CA) for 5 days every monthly cycle for 6 cycles total in 6 months. | Behavioural | Fasting Mimicking Diet |
| Standard Anti-Cancer DietWill receive standard of care diet and exercise recommendations from the study dietitian. The diet advice will be consistent with the American Cancer Society for cancer survivors and exercise recommendation of a goal of 150 minutes/week of cardiovascular exercise and weight resistance training at least twice a week. | Behavioural | Standard Anti-Cancer Diet |
Primary outcome
Response to cancer treatment
Time frame: 6 Month visit
Will be measured by the proportion of patients who achieved PSA nadir ≤0.2 ng/dL at any time point within the 6-month study and absolute PSA nadir.
8 secondary outcomes
Castration resistance 1
Time frame: 6 Month visit
Castration resistance 2
Time frame: 6 Month visit
Metabolic Toxicity 1
Time frame: Change from Baseline to 6 Month visit
Metabolic Toxicity 2
Time frame: Change from Baseline to 6 Month visit
Metabolic Toxicity 3
Time frame: Change from Baseline to 6 Month visit
Metabolic Toxicity 4
Time frame: Change from Baseline to 6 Month visit
Self-reported overall well-being
Time frame: Change from Baseline to 6 Month visit
Self-reported energy levels
Time frame: Change from Baseline to 6 Month visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fasting Mimicking Diet (FMD) and Standard Anti-Cancer Diet in people with Prostate Adenocarcinoma, run by Stephen Freedland at 3 sites 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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trial Recruitment Navigator (310-423-5842, GroupCancerTrialInformation@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response to cancer treatment (time frame: 6 Month visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.