Microbiome Molecular Charaterisation

Launched by INSTITUTE OF CANCER RESEARCH, UNITED KINGDOM · May 16, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how the bacteria in our gut, known as the microbiome, might affect the treatment of prostate cancer. Researchers want to better understand how prostate cancer develops and changes, especially when it becomes resistant to hormone therapy. They will collect tissue or cells from men with either newly diagnosed or advanced prostate cancer to see how gut bacteria might influence the effectiveness of treatments and any side effects patients may experience.

To be eligible for this study, participants must be men aged 18 or older who are currently being checked for prostate cancer or already have a diagnosis. They should also be healthy enough to undergo a biopsy, where a small sample of tissue is taken from their tumor. Participants will need to provide written consent and have recent PSA test results, which help monitor prostate cancer. If you join this study, you’ll help researchers learn more about how the gut microbiome might improve treatment outcomes and reduce side effects for men with prostate cancer.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Male \>=18 years.
• • 2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 - 2.
• • 3. Undergoing investigation for diagnosis, or with a proven diagnosis of prostate cancer and undergoing further investigation or clinical trial participation.
• • 4. 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.
• • 5. Willing and able to comply with the requirements of the sample collection including fresh tumour biopsy.
• • 6. The subject is capable of understanding and complying with the protocol requirements and has given written informed consent.
• • 7. A record of PSA levels within last 3 months.
• Exclusion Criteria:
• • 1. The presence of any haematological disorders, including coagulation disorders, which would be a contraindication if patient were to undergo a biopsy.
• • 2. Any psychiatric illness/social situations that would limit compliance with study requirements.
• • 3. 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.