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Plant-Based meals delivered to home may help prostate cancer patients fight weight gain

NCT ID NCT05471414

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether a whole-food, plant-based diet can help overweight or obese men with prostate cancer who are on hormone therapy (ADT) control their weight and reduce inflammation. About 76 men will either receive free plant-based meals at home or standard nutrition advice. The main goal is to see if the diet leads to weight loss after 4 weeks, with follow-ups up to 26 weeks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

76 people

The number who actually took part.

Started

Sep 2022

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

45 to 99 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria 1. Histologically or cytologically confirmed adenocarcinoma of the prostate 2. Receiving androgen deprivation therapy (ADT) with an LHRH/GnRH analogue (agonist/antagonist); or have undergone bilateral orchiectomy. Patients with localized prostate cancer, non-metastatic castrate resistant prostate cancer (CRPC), metastatic hormone sensitive prostate cancer and metastatic CRPC are all eligible. 3. On ADT for at least 24 weeks pre-study with anticipation of at least 26 more weeks of therapy from the date of initiation of the dietary intervention 4. Patients receiving an anti-androgen (including, but not limited to drugs such as bicalutamide, abiraterone, enzalutamide or apalutamide) are eligible if they have been on therapy for at least 3 months and plan to continue for the duration of the study 5. At least 3 months post completion of chemotherapy and/or radiation 6. Bone resorptive agents such as bisphosphanates and denosumab are allowed. 7. Testosterone level \<50 ng/dL 8. Age ≥ 45 years 9. BMI ≥ 27 10. ECOG performance status of 0 to 1 11. Adequate organ and marrow function, based upon meeting all of the following laboratory criteria: 1. White blood cell count ≥ 2500/mm3 (≥ 2.5 GI/L) 2. Platelets ≥ 100,000/mm3 (≥ 100 GI/L) without transfusion 3. Hemoglobin ≥ 9 g/dL (≥ 90 g/L) 4. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin ≤ 2x ULN (or for subjects with Gilbert's disease direct bilirubin WNL) Note: Subjects with elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) (up to 5x ULN) will be eligible if elevation is felt to be due to fatty liver disease related to obesity. 5. Serum albumin ≥ 2.8 g/dl 12. Willingness and ability to comply with all study-related procedures 13. Capable of understanding and complying with the protocol requirements and must have signed the informed consent document Exclusion Criteria 1. Insulin-dependent diabetes mellitus 2. Nut or legume allergy, gluten intolerance or celiac disease 3. Currently consuming a vegetarian or vegan diet 4. Concurrent participation in other nutrition or weight loss programs 5. Expected changes in chronic medications, including statins or oral diabetes medication during the study period (including a change in medication dosage) 6. Expected radiation, chemotherapy, bone resorptive agents or anti-androgen within 2 months of beginning the diet intervention 7. Expected changes in exercise patterns during the study period 8. Psychiatric illnesses or social situations that would limit compliance with study requirements, including a living situation that does not allow for the delivery of Plantable prepared meals, or the inability or lack of equipment to perform basic cooking tasks 9. Known history of electrolyte imbalance or micronutrient deficiency, e.g., magnesium, cobalamin 10. Ongoing use of warfarin anticoagulants 11. Diagnosed, active inflammatory bowel disease 12. Inability to receive Emails or have a smart phone

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Maryland, 21231, United States

  • Weill Cornell Medicine

    New York, New York, 10021, United States

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Other studies related to the condition(s) this trial covers.