Indolent prostate cancer, phytochemicals and probiotics

Not Applicable

• Conditions: Indolent prostate cancer; Cancer

• Registration Number: ISRCTN81939514
• Lead Sponsor: Bedford Hospital NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-06-19
• Last Update Posted: 30 October 2023
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: Male
• Target Recruitment: 180

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prostatic specific antigen doubling time (PSAdt) measured using a routine blood test analysis at trial entry baseline and 4 months

Secondary Outcome Measures

Name	Time	Method
The following secondary outcome measures will be assessed at baseline and 4 months:<br>1. Urinary symptoms measured using the International Prostate Symptoms score<br>2. Erectile function measured using the validated International Index of Erectile Function<br>3. Grip strength measured using a portable Hand help grip strength dynameter<br>