Indolent prostate cancer, phytochemicals and probiotics
| ISRCTN | ISRCTN81939514 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81939514 |
| IRAS number | 321309 |
| Secondary identifying numbers | IRAS 321309 |
- Submission date
- 13/06/2023
- Registration date
- 19/06/2023
- Last edited
- 06/11/2024
- Recruitment status
- Recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English Summary
Background and study aims
Emerging studies are linking poor gut health (dysbiosis) with greater risk and progression of prostate cancer (PCa). Various dietary and lifestyle factors influence dysbiosis but probiotic supplements have also been shown to improve the microbiome floral to a more favourable, less inflammatory profile. Likewise, studies have linked a higher intake of phytochemical-rich foods with a lower risk of PCa and progression of prostatic specific antigen (PSA), a protein produced by the prostate gland commonly used as a biomarker for prostate cancer detection and monitoring. Phytochemicals have numerous direct and indirect anti-cancer properties, including reducing excess chronic inflammation and enhancing oxidative pathways, but they also act as prebiotics, which supports commensal and ingested probiotic bacteria. The hypothesis for this study is that a probiotic supplement could enhance the benefits of a phytochemical-rich supplement via this synergistic effect. A combination of phytochemical-rich food and probiotic supplements has not previously been explored in a cohort of men with PCa, hence the rationale for this study. The aim of this study is to establish whether boosting the diet with a lactobacillus probiotic blend in addition to a phytochemical-rich food supplement will influence PSA progression. Secondary endpoints include an assessment of prostate-related symptoms (waterworks and erectile function) and well-being measured by grip strength.
Who can participate?
Adult men aged over 18 years old with histologically proven, early PCa, not taking androgen deprivation therapy (ADT), managed with surveillance
What does the study involve?
Following written informed consent, all men will be given the phytochemical-rich food supplement and asked to stop all other over-the-counter supplements. They will then be randomly assigned to take either a probiotic supplement or a placebo. The supplements will be taken twice a day for 4 months. The PSA doubling time (PSAdt), a method used to evaluate the progression and severity of prostate cancer based on changes in PSA levels over time, will be taken at baseline and 4 months together with measures of prostate symptoms and wellbeing.
The probiotic capsule will contain 10 billion colony-forming units (CFU) of 5 lactobacillus strains with built-in prebiotics. The phytochemical-rich capsule will contain whole foods which have previously reported potential benefits for men with PCa in epidemiological, laboratory and prospective studies (broccoli, green tea, pomegranate, turmeric, cranberry and ginger). The ingredients of both supplements have been shown to have a high safety profile in previous studies.
What are the possible benefits and risks of participating?
The possible benefits include the financial side, as men can stop all over-the-counter supplements, which many men already take - many will save money. Most men have a strong interest in nutrition and self-empowerment strategies so hopefully this study should provide welcomed information.
The possible risks include that both these food supplements have been used in previous studies with a low incidence of side effects with no significant reported adverse event. Mild abdominal Bloating occurred in 3% of participants - this is a possible side effect is this study.
Where is the study run from?
Bedford Hospital (UK)
When is the study starting and how long is it expected to run for?
February 2023 to October 2024
Who is funding the study?
Bedford Hospital Research Fund (UK)
Who is the main contact?
Prof Robert Thomas, robert.thomas@bedfordhospital.nhs.uk (UK)
Contact information
Principal Investigator
Bedford and Addenbrookes Cambridge University Hospital NHS Trusts
c/o The Primrose Research Unit
Bedford
MK42 9DJ
United Kingdom
 ORCID ID |
0000-0002-3824-5615 |
|---|---|
| Phone | +44(0)1234 795787 |
| robert.thomas@bedfordhospital.nhs.uk |
Scientific
Chief investigator and scientific contact
Consultant urological surgeon
Bedford Hospital
Bedford Hospital NHS Trust
Bedford
MK42 9DJ
United Kingdom
| Phone | +44 (0)1234795787 |
|---|---|
| Zahoor.Fazili@bedfordhospital.nhs.uk |
Public
Research Manager Bedford Hospital
c/o The Primrose Unit
Bedford Hospital
Bedford Hospital NHS Trust
Bedford
MK42 9DJ
United Kingdom
| Phone | +44 (0)1234795787 |
|---|---|
| madeleine.williams@bedfordhospital.nhs.uk |
Study information
| Study design | Randomized double-blind controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Safety, Efficacy |
| Participant information sheet | 43788_PIS_24May2023.pdf |
| Scientific title | Do probiotics aid men with indolent prostate cancer in addition to phytochemical-rich whole foods? A randomised, double-blind, placebo-controlled trial |
| Study acronym | The YourPhyto Study |
| Study hypothesis | A food capsule, containing lactobacillus probiotic, in addition to a phytochemical-rich whole food capsule, could have an influence on prostate-specific antigen (PSA) progression compared to men taking a phytochemical-rich whole food supplement alone, among men with prostate cancer, managed with surveillance. |
| Ethics approval(s) |
Approved 12/10/2023, East Midlands - Nottingham 1 Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 207 104 8115; Nottingham1.rec@hra.nhs.uk), ref: 321309 |
| Condition | Indolent prostate cancer |
| Intervention | This is a double-blind, randomised, controlled trial in men who have a diagnosis of indolent prostate cancer managed with surveillance alone. Following written informed consent, patients will be randomised (1:1) to: • Men in one randomised arm (blinded) will receive a phytochemical-rich food supplement (PFS) containing whole dried pomegranate, turmeric, green tea, broccoli, cranberry and ginger plus a probiotic capsule containing a blend of 10 billion colony-forming units (CFU) of 5 lactobacilli plus inulin and low dose cholecalciferol as prebiotics. • Men in the other blinded randomised group will be given the PFS plus placebo Each capsule will be taken twice a day, for 4 months. Participants are asked to stop all other over-the-counter supplements The phytochemical-rich capsule contains dried whole foods which have previously been reported as safe among men with prostate cancer in prospective studies. The ingredients of both supplements have been shown to have a high safety profile. This blend has been used in two previous studies and was safe and well-tolerated. Computer generated Block Randomisation will be employed. A spreadsheet will be created; in column 1, sequential participant numbers will be recorded. In column 2, block-generated randomised Arms (A or B), will be recorded. After a participant has consented they will be allocated the next trial number and randomised Arm in strict order. Participants will be given a four-month supply of either "A" or "B" plus the whole food supplement. Contact will be face-to-face consultations with the medical team at baseline and at trial termination during their routine clinical management for surveillance. Location: Primrose Oncology Research Unit within the Oncology department of Bedford Hospital, Bedfordshire Hospitals NHS Foundation Trust, which specialises in Prostate cancer. Prostatic specific antigen doubling time (PSAdt) will be taken at baseline and 4 months together with measures of prostate symptoms, erectile function and strength. |
| Intervention type | Supplement |
| Primary outcome measure | Prostatic specific antigen doubling time (PSAdt) measured using a routine blood test analysis at trial entry baseline and 4 months |
| Secondary outcome measures | The following secondary outcome measures will be assessed at baseline and 4 months: 1. Urinary symptoms measured using the International Prostate Symptoms score 2. Erectile function measured using the validated International Index of Erectile Function 3. Grip strength measured using a portable Hand help grip strength dynameter |
| Overall study start date | 02/02/2023 |
| Overall study end date | 01/10/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | Male |
| Target number of participants | 180 |
| Participant inclusion criteria | 1. Histologically confirmed prostate cancer 2. Written informed consent 3. No current androgen deprivation or other medication for prostate cancer 4. Patients who are willing to comply with an oral food supplement 5. Patients who are willing to cease all non-trial, over-the-counter oral food supplements 6. Patients considered for surveillance or watch and wait for strategy, following multidisciplinary team discussion |
| Participant exclusion criteria | 1. No histological diagnosis of prostate cancer 2. Not willing to stop other over-the-counter supplements 3. Patients with liver function tests more than twice the abnormal laboratory range 4. Patients with gastric or small bowel malabsorption or dysfunction 5. Patients with a known allergy to any of the trial food components. |
| Recruitment start date | 01/08/2023 |
| Recruitment end date | 01/08/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Bedford
MK42 9DJ
United Kingdom
Sponsor information
Hospital/treatment centre
South Wing
Kempston Road
Bedford
MK42 9DJ
England
United Kingdom
| Phone | +44 (0)1234792023 |
|---|---|
| mohammad.wasil@bedfordhospital.nhs.uk | |
| Website | https://www.bedfordhospital.nhs.uk/ |
"ROR" |
https://ror.org/031nbgr73 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/12/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | After external audit and independent statistical analysis, the data will be presented at an international conference and submitted to a peer reviewed scientific paper |
| IPD sharing plan | No personal patient identifying information will be available on any date. After the datasets for both randomised groups have been externally audited and statistically validated it will made available to the public, in an excel spread sheet on the trials website (A page on http://www.cancernet.co.uk) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 24/05/2023 | 19/06/2023 | No | Yes | |
| Protocol file | 17/05/2023 | 19/06/2023 | No | No |
Additional files
Editorial Notes
06/11/2024: The overall study end date was changed from 01/12/2025 to 01/10/2024.
20/10/2023: The following changes were made to the trial record:
1. The acronym was added.
2. The ethics approval was added.
21/06/2023: Internal review.
19/06/2023: Trials' existence confirmed by Bedford Hospitals Research Trust (UK).
