Microbiome Molecular Charaterisation
ConditionProstate Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorInstitute of Cancer Research, United Kingdom
About this trial
Preclinical models of prostate cancer have proved to be poorly predictive of the behaviour of the disease in patients. This protocol describes the acquisition of prostate cancer tissue or cells from patients with treatment naïve/hormone-sensitive and castration-resistant prostate cancer or patients undergoing diagnostic or follow up investigations. The knowledge gained will improve the investigators' understanding of the steps leading to the development of castration resistance and identify new molecular targets for treatment.
The human microbiome has been under investigation in a range of human diseases (i.e. metabolic disease/obesity, neurological disorders, cardiovascular disease, mental disorders, autoimmune disease, asthma and allergies) and cancer. The human microbiota can have direct (e.g. via direct genotoxicity, induction of chronic inflammation, etc.) and/or indirect (e.g. effects on tumour effects on tumour development or progression exerted through microbial communities that exist at a site distant to the tumour) effects on the disease. Emerging data supports the influence of the gut microbiota on the efficacy of anti-cancer treatments, including immunotherapy. To date, the impact of the gut microbiome on prostate cancer therapies is virtually unexplored. Based on the evidence to date, the investigators hypothesize that the gut flora may be altered by certain treatments for advanced prostate cancer, and that the composition of the microbiome in the gastrointestinal tract may be used to predict therapeutic efficacy or therapy-related toxicities; as well as prevent treatment toxicity and/or enhance treatment response.
Furthermore, the purpose is to investigate the association between gut flora and treatment response and related toxicities/morbidities in advanced prostate cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male >=18 years.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 - 2.
Undergoing investigation for diagnosis, or with a proven diagnosis of prostate cancer and undergoing further investigation or clinical trial participation.
Patients with tumour deemed by the designated investigator as safely suitable for fresh biopsy AND who are medically fit (according to local practice) to undergo a biopsy or surgical procedure to acquire tumour tissue.
Disqualifiers
The presence of any haematological disorders, including coagulation disorders, which would be a contraindication if patient were to undergo a biopsy.
Any psychiatric illness/social situations that would limit compliance with study requirements.
Presence of any concurrent condition or situation, which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study.
Trial population
The sample size is not based on formal statistical power analyses but rather on pragmatic and feasibility considerations. Our experience with our previous MC study lets us assume that we will be able to recruit 200 patients per year (from 1-2 participating centres) over a recruitment period of five years. Thus, the total expected sample size will be 1000 patients. The expected study endpoint analysis will commence following the 5-year recruitment period but no longer than the overall 15-year end of study timeline.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Sequencing study
Other interventionSequencing of tumour samples for microbiome analysis and molecular charcterisation.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Microbiome composition in prostate cancer patients
Describing the microbiome composition in prostate cancer patients using metagenomic and metabolomic studies.
Time frame
through study completion, an average of 1 yearSecondary outcomes
1
Prevalence of prostate cancer aberrations
Prevalence of prostate cancer aberrations including at DNA, RNA, protein or metabolite level.
Time frame
through study completion, an average of 1 year2
Patient clinical outcomes
Overall response rate defined as the proportion of patients with partial or complete response to a given treatment according to clinical \[Symptoms\], biochemical \[PSA\] or radiographic criteria (e.g., RECIST). * Prognostic clinical parameters - Hb \[Haemoglobin\], Albumin, LDH \& ALP * Time to castration resistance defined as time from study entry to diagnosis of castration resistant prostate cancer. * Time to treatment progression defined as time from start of therapy to progression (clinical \[Symptoms\], biochemical \[PSA\], or radiographic) on treatment. * Progression-free survival defined as the time from start of treatment to progression on treatment (clinical \[Symptoms\], biochemical \[PSA\] or radiographic) or death from any cause. * Overall survival defined as time from study entry to death from any cause.
Time frame
time to castration resistance, time to treatment progression and overall survival.Sponsors and contacts
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Source ClinicalTrials.gov