Indolent prostate cancer Cancer
Conditions
Interventions
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 rando
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
Sponsors
Bedford Hospital NHS Trust
Eligibility
Sex/Gender
Male
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prostatic specific antigen doubling time (PSAdt) measured using a routine blood test analysis at trial entry baseline and 4 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
England, United Kingdom
Contacts
Public ContactMadeleine Williams
Outcome results
None listed