Blood biomarkers to predict therapy response in prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational study that groups participants by disease stage and planned cancer treatment and collects blood samples for biomarker analysis. A single 12 ml EDTA blood draw is taken for some cohorts, while other cohorts have baseline sampling before treatment and repeated sampling every 3 months (with some interim checks) for up to 3 years or until recurrence/progression. Some groups have only a single-time sampling (including rectal swab for a setup group), while others follow a scheduled longitudinal collection tied to clinical events. Samples will be analyzed for biological markers (including exosome-related and other blood biomarkers) to see if patterns predict treatment response or disease course.

Why it matters

Who can join: the full rules

Inclusion Criteria:

General inclusion criteria (for entering all groups)

* Age ≥ 18 years
* Histological diagnosis of prostate adenocarcinoma at different stages of disease (see Section 6.2) for which a treatment is indicated
* Written Informed Consent

Inclusion criterion only for entering Group 0

• Patients with a known diagnosis of CSPC or CRPC

Inclusion criterion only for entering Group 1a

• Patients that underwent biopsies for a suspect of PC, but resulted negative for cancer

Exclusion Criteria:

General exclusion criteria (for entering all groups)

* Active infection requiring treatment
* Decrease of general condition
* Concomitant severe comorbities
* Difficult socioeconomic conditions making regular follow up unfeasible.
* Need of concomitant steroids at study entry and during the study
* Diagnosis of second tumor in the previous 5 years

Exclusion criterion only for entering Group 0

• No antibiotic treatments in the previous 2 months before enrollment

Exclusion criteria only for entering Group 1

* Previous radical surgery and / or radical radiotherapy
* Previous hormonal treatments

Exclusion criteria only for entering Group 2

* No antibiotic treatments in the previous 2 months before enrollment (only in patients enrolling also for metagenomics and metabolomics)
* Previous hormonal treatments for advanced disease

Exclusion criterion only for entering Group 3

• No antibiotic treatments in the previous 2 months before enrollment (only in patients enrolling also for metagenomics and metabolomics analyses)

Where it's running

• Oncology Institute of Southern Switzerland (IOSI)
  Bellinzona, Switzerland Recruiting

Study contacts

• Principal investigator: Ricardo Pereira Mestre, MD — Oncology Institute of Southern Switzerland (IOSI)
• Study coordinator: Ricardo Pereira Mestre, MD
• Email: ricardo.pereiramestre@eoc.ch
• Phone: +41 (0)91 811 8446

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.