Blood biomarkers to predict therapy response in prostate cancer
An Exploratory proof-of Valid Biomarkers in Blood to Predict the Response to Therapy in Prostate Cancer Patients, a Single Center Study
Oncology Institute of Southern Switzerland · NCT03408964
This project will test whether blood biomarkers can predict how people with prostate cancer will respond to their treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Oncology Institute of Southern Switzerland (other) |
| Locations | 1 site (Bellinzona) |
| Trial ID | NCT03408964 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (age ≥18) with histologically confirmed prostate adenocarcinoma at various stages who are able to provide informed consent and either are about to start or are receiving indicated antitumor treatment, plus a control subgroup of men with negative prostate biopsies.
Not a fit: Patients with active infections, significant comorbidities, recent second cancers, those needing systemic steroids, or those unable to adhere to follow-up are unlikely to benefit or may be ineligible.
Why it matters
Potential benefit: If successful, this could allow doctors to use a simple blood test to predict treatment response and better tailor therapy for people with prostate cancer.
How similar studies have performed: Similar blood-based approaches (circulating tumor DNA, circulating tumor cells, exosomes) have shown promising but inconsistent results, so the approach is plausible but not yet proven.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Bellinzona
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prostate Cancer