Prostate CancerNCT07220499
Whole Food Plant-based Diet to Improve Outcomes in Prostate Cancer
A study testing Whole Food Plant-based Diet in people with Prostate Cancer, run by Pacific Cancer Care at 1 site in United States.
Trial summary
The purpose of this research is to determine if consuming a whole food plant-based diet for six months impacts outcomes in men with prostate cancer that have a rising prostate-specific antigen (PSA) level. Read more about this study
- Who is it for?
- Ages 45 to 99 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Whole Food Plant-based Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2023to 25 Sep 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 45 to 99 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males 45-99 years of age
- Histologically or cytologically confirmed adenocarcinoma of the prostate
- Increasing PSA on at least 2 sequential tests not more than 6 months apart.
- Eastern Cooperative Oncology Group Performance Status Scale of 0 to 2
- Adequate organ and marrow function, based upon meeting all of the following laboratory criteria:
- White blood cell count ≥ 2500/mm3 (≥ 2.5 GI/L)
Show all 11Show fewer
- Platelets ≥ 50,000/mm3 (≥ 100 GI/L) without transfusion
- Hemoglobin ≥ 9 g/dL (≥ 90 g/L)
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin ≤ 2x upper limit of normal (or for subjects with Gilbert's syndrome direct bilirubin WNL) Serum albumin ≥ 2.8 g/dl
- Willingness and ability to comply with all study-related procedures
- Capable of understanding and complying with the protocol requirements and must have signed the informed consent document
Who cannot join
- Nut or legume allergy
- Currently consuming a vegetarian or vegan diet
- Concurrent participation in other nutrition or weight loss programs
- Expected changes in exercise patterns during the study period
- Active prostatitis
- Insulin-dependent or requiring diabetes mellitus
Show all 13Show fewer
- Expected changes in chronic medications, including statins or oral diabetes medication during the study period (including a change in medication dosage)
- Expected radiation, chemotherapy, bone resorptive agents or anti-androgen within 2 months of beginning the diet intervention
- Known history of electrolyte imbalance or micronutrient deficiency, e.g., magnesium, cobalamin
- Ongoing use of warfarin anticoagulants
- Diagnosed, active inflammatory bowel disease
- Alcohol and/or drug abuse
- Psychiatric illnesses or social situations that would limit compliance with study requirements including the inability or lack of equipment to perform basic cooking tasks
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this research is to determine if consuming a whole food plant-based diet for six months impacts outcomes in men with prostate cancer that have a rising prostate-specific antigen (PSA) level. The main questions it aims to answer are:
Does a whole-food plant-based impact PSA? Does a whole food plant-based diet impact risk factors associated with treatment for prostate cancer including LDL cholesterol, hemoglobin A1C, C-reactive protein?
Participants will be asked to attend twelve two-hour plant-based cooking and nutrition classes throughout a six-month period, consume a mostly whole food plant-based diet, provide blood samples, and complete three-day food journals to assess nutrient intake.
Read the detailed description
Ten men with histologically or cytologically confirmed adenocarcinoma of the prostate will be recruited from local urologists and oncologists. Eligible participants will be asymptomatic with a rising PSA on at least two tests no more than 6 months apart. Participants will come from one of four categories: 1) early stage, not on therapy; 2) non-metastatic prostate cancer on therapy; 3) metastatic, not on therapy; 4) metastatic, on antiandrogen (i.e. leuprolide) therapy that is no longer effective.
Participants will attend 12 two-hour group educational sessions at Pacific Cancer Care over the course of 24 weeks to encourage increased consumption of whole plant foods including fruits, vegetables, legumes, nuts, seeds, and decreased consumption of processed and animal foods including refined carbohydrates, meat, seafood, eggs, and dairy. Strict elimination of animal foods will not be required allowing dietary flexibility.
Educational sessions will consist of a 1-hour presentation on various nutrition topics with an emphasis on the benefits of whole plant foods, a 30-minute cooking demonstration of a whole food plant-based meal and taste test, and a 30-minute discussion. Participants will be encouraged to bring one support person, preferably someone they share meals with such as a spouse, to the sessions. A booklet summarizing the information presented in the educational sessions, including whole food plant-based recipes, will be provided to participants and their support person. Participants will be provided with a "take-home" ingredient that was used to prepare the meal in class and organic produce boxes from weeks 1 through 9 and $20 gift cards for weeks 10 through 24.
The primary outcome will be change in PSA, which will be measured at baseline, 12 weeks, and 24 weeks. Secondary outcome measures will be assessed at baseline and 24 weeks including changes in nutrient intake as assessed by 3-day food journals, LDL cholesterol, hemoglobin A1C, and high sensitivity C-reactive protein. Insulin-like growth factor-1 and insulin-like growth factor binding protein-3 will also be measured.
- Conditions
- Prostate Cancer
- Being tested
- Whole Food Plant-based Diet
- Keywords
- whole food plant-based diet
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Food Plant-based DietOther
6-months of a predominately whole food plant-based diet
| Study group | Role | What they receive |
|---|---|---|
| Whole Food Plant-based Diet | Experimental | Not described Receives: Other: Whole Food Plant-based Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prostate Specific Antigen
Measured: 6 months
Secondary outcomes (3)
LDL-cholesterol
mg/dL
Measured: 6 months
Hemoglobin A1C
% of total hemoglobin
Measured: 6 months
high sensitivity C-reactive protein
mg/L
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2025
- Study start7 Nov 2023
- Primary completion25 Sep 2025
- Study completion25 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacific Cancer Care
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dorothy Tenney, Pacific Cancer Care
- Investigators
- John Hausdorff, MD, Principal investigator, Pacific Cancer Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07220499
- Sponsor's protocol ID
- PCC-001
- Status last verified
- Oct 2025
- First submitted
- 21 Oct 2025
- Last updated
- 24 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole Food Plant-based Diet to Improve Outcomes in Prostate Cancer
- ClinicalTrials.gov ID
- NCT07220499
- Acronym / sponsor ID
- PCC-001
- Conditions
- Prostate Cancer
- Keywords
- whole food plant-based diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Pacific Cancer CareUniversity, hospital or other
- Study start
- 7 Nov 2023 (actual)
- Primary completion
- 25 Sep 2025 (actual)
- Study completion
- 25 Sep 2025 (actual)
- First posted
- 24 Oct 2025 (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.
The purpose of this research is to determine if consuming a whole food plant-based diet for six months impacts outcomes in men with prostate cancer that have a rising prostate-specific antigen (PSA) level. The main questions it aims to answer are:
Does a whole-food plant-based impact PSA? Does a whole food plant-based diet impact risk factors associated with treatment for prostate cancer including LDL cholesterol, hemoglobin A1C, C-reactive protein?
Participants will be asked to attend twelve two-hour plant-based cooking and nutrition classes throughout a six-month period, consume a mostly whole food plant-based diet, provide blood samples, and complete three-day food journals to assess nutrient intake.
Detailed description
Ten men with histologically or cytologically confirmed adenocarcinoma of the prostate will be recruited from local urologists and oncologists. Eligible participants will be asymptomatic with a rising PSA on at least two tests no more than 6 months apart. Participants will come from one of four categories: 1) early stage, not on therapy; 2) non-metastatic prostate cancer on therapy; 3) metastatic, not on therapy; 4) metastatic, on antiandrogen (i.e. leuprolide) therapy that is no longer effective.
Participants will attend 12 two-hour group educational sessions at Pacific Cancer Care over the course of 24 weeks to encourage increased consumption of whole plant foods including fruits, vegetables, legumes, nuts, seeds, and decreased consumption of processed and animal foods including refined carbohydrates, meat, seafood, eggs, and dairy. Strict elimination of animal foods will not be required allowing dietary flexibility.
Educational sessions will consist of a 1-hour presentation on various nutrition topics with an emphasis on the benefits of whole plant foods, a 30-minute cooking demonstration of a whole food plant-based meal and taste test, and a 30-minute discussion. Participants will be encouraged to bring one support person, preferably someone they share meals with such as a spouse, to the sessions. A booklet summarizing the information presented in the educational sessions, including whole food plant-based recipes, will be provided to participants and their support person. Participants will be provided with a "take-home" ingredient that was used to prepare the meal in class and organic produce boxes from weeks 1 through 9 and $20 gift cards for weeks 10 through 24.
The primary outcome will be change in PSA, which will be measured at baseline, 12 weeks, and 24 weeks. Secondary outcome measures will be assessed at baseline and 24 weeks including changes in nutrient intake as assessed by 3-day food journals, LDL cholesterol, hemoglobin A1C, and high sensitivity C-reactive protein. Insulin-like growth factor-1 and insulin-like growth factor binding protein-3 will also be measured.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Whole Food Plant-based Diet | Experimental | Other: Whole Food Plant-based Diet |
Who may qualify
- Ages
- 45 to 99 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Males 45-99 years of age
- Histologically or cytologically confirmed adenocarcinoma of the prostate
- Increasing PSA on at least 2 sequential tests not more than 6 months apart.
- Eastern Cooperative Oncology Group Performance Status Scale of 0 to 2
- Adequate organ and marrow function, based upon meeting all of the following laboratory criteria:
Key exclusion criteria (13 listed)
- Nut or legume allergy
- Currently consuming a vegetarian or vegan diet
- Concurrent participation in other nutrition or weight loss programs
- Expected changes in exercise patterns during the study period
- Active prostatitis
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 |
|---|---|---|
| Whole Food Plant-based Diet6-months of a predominately whole food plant-based diet | Other | Whole Food Plant-based Diet |
Primary outcome
Prostate Specific Antigen
Time frame: 6 months
3 secondary outcomes
LDL-cholesterol
Time frame: 6 months
Hemoglobin A1C
Time frame: 6 months
high sensitivity C-reactive protein
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2025.
- Individual participant dataSharing planned: Yes. Data will be made available upon reasonable request.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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. This study is not recruiting at the moment.
John Hausdorff, MD principal investigator
Pacific Cancer Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole Food Plant-based Diet in people with Prostate Cancer, run by Pacific Cancer Care 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 13 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 24 Oct 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?
Prostate Specific Antigen (time frame: 6 months). 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 24 Oct 2025.