Valid Biomarkers in Blood to Predict the Response to Therapy in Prostate Cancer Patients

Oncology Institute of Southern Switzerland (IOSI)

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Other: biological samples collection and analysis

Study type: Observational

Funder types: Other

Identifiers

NCT03408964

IOSI-IOR-002

Details and patient eligibility

About

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.

Full description

Participants to the study will be assigned to 5 cohorts according to the stage of disease and planned antitumor treatment at time of study entry.

Group 0 (set-up): blood sampling and rectal swab will be collected at a single time-point during the PC treatment. No follow-up is required.

Group 1a (control): the first blood sampling will be performed within 4 weeks since the negative biopsy; subsequent samplings will be done according to a schedule comparable to that of Group 1 up to 1 year or evidence of tumor, whichever occurs first.

Group 1, Group 2 and Group 3: the first blood sampling will be performed before radical treatment or HT start or CT start, on the basis of the planned antitumor therapy; subsequent sampling will be done after radical intervention at 4 weeks (only for Group 1) and then every 3 months (or more frequently if clinically indicated), up to 3 years or evidence of tumor recurrence/progression (radiological or biochemical), whichever occurs first.

At the time of recurrence/progression, patients of Group 1 could become part and could be followed as per Group 2, and patients of Group 2 could become part and could be followed as per Group 3.

Group Exo and Group Bio: blood sampling will be performed at a single time-point during the PC treatment. No follow-up is required.

Enrollment: 600 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

600 participants in 7 patient groups

Group 0 (set-up)

Description:

Patients with known diagnosis of CSPC (Group 0a) and CRPC (Group 0b) irrespective of the PC treatment (not first diagnosis)

Treatment:

Other: biological samples collection and analysis

Group 1a (control)

Description:

Patients who underwent biopsies for suspected Prostate Cancer (PC), with a negative result for invasive cancer

Treatment:

Other: biological samples collection and analysis

Group 1

Description:

Patients with a first diagnosis of localized biopsy-proven PC, untreated, planned to undergo radical surgery and / or radical radiotherapy

Treatment:

Other: biological samples collection and analysis

Group 2

Description:

Patients with a diagnosis of locally advanced unresectable, recurrent or metastatic PC planned to receive first-line hormono therapy

Treatment:

Other: biological samples collection and analysis

Group 3

Description:

Patients with recurrent/progressive/metastatic CRPC planned to receive chemotherapy

Treatment:

Other: biological samples collection and analysis

Group Exo

Description:

Patients with a known or suspected diagnosis of PC or at any stage of the disease and irrespective of the treatment undergoing an imaging investigation.

Treatment:

Other: biological samples collection and analysis

Group Bio

Description:

Patients with a known or suspected diagnosis of PC at any stage of the disease and irrespective of the treatment undergoing a tumour sampling.

Treatment:

Other: biological samples collection and analysis