Valid Biomarkers in Blood to Predict the Response to Therapy in Prostate Cancer Patients
An Exploratory proof-of Valid Biomarkers in Blood to Predict the Response to Therapy in Prostate Cancer Patients, a Single Center Study
About This Trial
- This study is researching whether routine blood tests can help doctors predict how well prostate cancer treatments will work for each person.
- It is open to adults diagnosed with prostate cancer at various stages who are planning to start a new treatment.
- Instead of testing a new drug, the study only requires giving small blood samples at different times during your care.
- Before joining, you should know that having other major health conditions, active infections, or another cancer within the past five years will make you ineligible.
More Information
- Participants to the study will be assigned to 7 cohorts according to the stage of disease and planned antitumor treatment at time of study entry.
- In all patients, 12 ml of blood sample will be collected in EDTA tube for analysis of biological biomarkers in different time points.
Who Can Enroll
- Age Range: 18 years and older
- Gender: Male
- Who This Trial is For: This study is researching whether routine blood tests can help doctors predict how well prostate cancer treatments will work for each person.
Study Details
- Start Date: December 15, 2017
- Lead Sponsor: Oncology Institute of Southern Switzerland
Full Eligibility 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)
Treatments
- Other: biological samples collection and analysis