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Completed

NCT Number: NCT07790003

Dietary Fibre Supplementation to Delay Disease Progression in Early Prostate Cancer

This qualitative research study, based on semi-structured interviews and a focus group, aims to explore the attitudes of prostate cancer patients on active surveillance (AS) towards dietary fibre supplementation, given the potential benefits demonstrated in previous research. Prostate cancer patients on AS, often overlooked in the literature, experience cyclical anxiety, particularly regarding disease progression. Lifestyle modifications, including dietary changes, are pursued by a number of these patients as a preventative measure. Dietary fibre such as inulin and psyllium have promising results in studies of pelvic cancers. However, it is important to note that these findings do not directly apply to patients who are currently undergoing AS for prostate cancer. Despite potential side effects, these dietary fibres may contribute to anti-inflammatory and antitumorigenic effects.

Building on this evidence, the investigators aim to explore patient perspectives on the feasibility and acceptability of dietary fibre supplementation during AS. The insights gained will guide the development of a feasibility and/or pilot studies and, subsequently, a multicentre randomised controlled trial. If successful, this intervention could potentially reshape clinical practice for patients with prostate cancer on AS.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

NHS Grampian - Aberdeen Royal Infirmary

Aberdeen, Aberdeen City, AB25 2ZD, United Kingdom

About this study

Active surveillance (AS) is commonly recommended for men diagnosed with localised prostate cancer who have a low risk of tumour spread. If the prostate cancer progresses to a more aggressive form, this will require active treatment - typically surgical removal of the prostate (radical prostatectomy) or radical radiotherapy to the prostate.

At Aberdeen Royal Infirmary (ARI) Urological unit, the AS protocol involves repeat MRI scans and biopsies being performed at the end of year 1, followed by subsequent radiological and histological investigations every two years, accompanied by either 3- or 6-monthly routine monitoring of specific biochemical (i.e. prostate-specific antigen) levels. In other words, AS is a clinical pathway that aims to monitor early prostate cancer, rather than treating it straight away.

Men undergoing AS, an often-overlooked group in the literature, experience certain levels of cyclical anxiety. This cohort may experience persistent apprehension regarding disease progression, with the fear lingering in the background of their thoughts. Anxiety intensifies around routine appointments with the AS protocol, and new concerns may emerge, particularly relating to fluctuations in their PSA levels. In a recent descriptive analysis, it was found that out of the 43.6% of men who discontinued AS after five years, roughly 12.8% of dropouts occurred because they converted to active treatment without any evidence of disease progression. Therefore, a considerable number of patients exhibit a strong inclination to actively engage in lifestyle modifications in an effort to attempt the prevention of disease progression. This approach includes an interest in modifying their dietary habits.

Dietary fibre, such as psyllium and inulin, are non-digestible carbohydrates that are found in fruits, vegetables, whole grains and legumes. The gut microbiota anaerobically ferments dietary fibre, producing short-chain fatty acids (SCFAs), including acetate, propionate and butyrate. SCFAs play a pivotal role in the intricate relationship between food, gut microbiota and health, exhibiting notable anti-inflammatory and anti-tumorigenic properties.

In a population-based case-only study conducted in the USA, higher fibre intake was inversely associated with prostate cancer aggressiveness (odds ratios 0.70, 95% confidence interval 0.50-0.97 and 0.61 95% CI 0.40-0.93, for 2nd and 3rd tertiles of total fibre intake, respectively). Additionally, a prospective phase II dietary intervention study, using the fibre supplement modified citrus pectin in men with non-metastatic prostate cancer who had biochemically relapsed, showed promising results. 78% of men responded to the therapy, with 58% having a decreased or stable PSA and 75% an improvement in PSA doubling time (PSADT), and median PSADT was significantly improved (p=0.003).

The Kiltie Lab and others have demonstrated the benefit of the rapidly fermented, soluble dietary fibre inulin in controlling tumour growth in mice compared to low dietary fibre intake, in a range of tumour types (including prostate, colorectal cancer and bladder cancer). However, this can come at the expense of side effects in humans including flatulence and bloatedness. Psyllium is another fibre which is commonly used to treat constipation but it is also widely used to treat the diarrhoea caused by radiotherapy to the prostate region. Recently, the addition of psyllium was found to significantly reduce gas production in the colon from the fermentation of inulin, in human subjects with irritable bowel syndrome.

Given this body of evidence, the investigators would like to explore and evaluate the attitudes of patients regarding the potential of dietary fibre supplementation during AS. It is hoped that this qualitative research will provide valuable insights that will support and inform the development of a pilot and feasibility studies on dietary fibre supplementation for prostate cancer patients on AS, delaying the time to active treatment or obviating its use. Subsequently, the intention is to establish a UK multicentre, randomised controlled trial. This may subsequently change clinical practice for patients with prostate cancer on AS.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants over 18 years of age.
  • Participants with residence in North-East Scotland.
  • Participants must be fluent in the English language.
  • Participants on active surveillance.

Exclusion criteria

  • Participants who do not speak fluent English will be excluded from this study.
  • Participants who were treated with surgery, radiotherapy, chemotherapy or anti-androgen therapy for their prostate cancer.
  • Vulnerable participants, classified as adults who do not have the capacity to consent for themselves, will not be included in the study. If the research team are made aware that someone has lost capacity then they will be withdrawn from the study.

Treatment and study plan

Qualitative semi-structured interviews

Other

The research fellow will conduct a total of 12 semi-structured individual interviews, either via video (MS Teams) or telephone format, based on participant preference. The investigators will employ a semi-structured interview methodology as it collects richer data and allows for in-depth exploration of the participant's insights. Interviews will be conducted at a time convenient to the participant. The topic guide will structure the interview format. Each participant will be interviewed only once.

Focus Group

Other

Subsequently, the investigators will hold one focus group online via video (MS Teams) with six participants, which will be run by the research fellow and one of the academic supervisors. The topic guide will structure the interview format.

Primary outcomes

  1. Attitudes and preferences of men on active surveillance for prostate cancer regarding dietary supplementation.

    Time frame: At a single interview following enrolment (approximately 30-45 minutes)

    Semi-structured interviews will explore men's views on incorporating dietary fibre supplementation (inulin with or without psyllium), into active surveillance for prostate cancer. Responses will be analysed thematically using the Theoretical Framework of Acceptability.

Secondary outcomes

  1. Barriers/facilitators to dietary fibre adherence during active surveillance

    Time frame: At a single interview following enrolment (approximately 30-45 minutes)

    Same semi-structured interviews will explore the practical and personal factors that may make it easier or more difficult for men to regularly take dietary fibre supplements during active surveillance. Responses will be analysed thematically using the Theoretical Framework of Acceptability.supplementation among men on active surveillance, including any physical, emotional or psychological effects.

Sponsors and collaborators

Lead sponsor

University of Aberdeen

Other

Collaborators

  • Friends of ANCHOR

Registry information

Acronym: DEFINITE

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 27, 2026
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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