Understanding the role of the microbiome in prostate cancer

Collection of Clinical Material From Patients With Prostate Cancer or Undergoing Investigation for Diagnostic or Follow up Purposes for Molecular Characterisation and Microbiome Analysis

This study is trying to see how the bacteria in our bodies might affect prostate cancer and its treatment by collecting tissue samples from patients with different stages of the disease.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: Institute of Cancer Research, United Kingdom (other)
• Drugs / interventions: immunotherapy, chemotherapy, cyclophosphamide
• Locations: 1 site (Sutton, Surrey)
• Trial ID: NCT06423976 on ClinicalTrials.gov

What this trial studies

This observational study aims to collect prostate cancer tissue or cells from patients with treatment-naïve, hormone-sensitive, and castration-resistant prostate cancer. By analyzing these samples, researchers hope to gain insights into the development of castration resistance and identify new molecular targets for treatment. The study also explores the impact of the human microbiome on cancer progression and treatment response, leveraging recent findings that suggest a link between microbiota composition and therapeutic efficacy. Participants will undergo fresh biopsies to provide the necessary samples for sequencing and analysis.

Who should consider this trial

Good fit: Ideal candidates include males aged 18 and older with a diagnosis of prostate cancer who are undergoing further investigation or clinical trial participation.

Not a fit: Patients with hematological disorders or those unable to undergo a biopsy due to medical contraindications may not benefit from this study.

Why it matters

Potential benefit: If successful, this research could lead to improved treatment strategies for prostate cancer by identifying new molecular targets and understanding the role of the microbiome.

How similar studies have performed: While the role of the microbiome in cancer treatment is being explored, this specific approach focusing on prostate cancer is relatively novel and has not been extensively tested.

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.

Where this trial is running

Sutton, Surrey

• Institute of Cancer Research/Royal Marsden NHS FT — Sutton, Surrey, United Kingdom (RECRUITING)

Study contacts

• Principal investigator: Johann De-Bono — The Royal Marsden NHS FT\The Institute of Cancer Research
• Study coordinator: Omobola Fadahunsi

Conditions: Prostate Cancer