Prostate cancer Cancer
Conditions
Interventions
Longitudinal blood sampling is carried out with isolation and storage of plasma, serum and PBMCs
PSA dosage is performed from serum
analysis of circulating microRNAs, sphingolipids and proteins is carried out from plasma
totRNA-sequencing is done starting from fixed tissue
image analysis is performed on digital pathology records
urine samples and questionnaire records on recent clinical history, family history of (prostate) cancer and lifestyle are collected at baseline.
For the ancillary study: PSA levels, functional tests
Sponsors
Fondazione Edo ed Elvo Tempia
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Informed consent signed 2. Males, caucasian 3. 50-79 years 4. Availability of clinical records Only for the ancillary NW study: 5. Willing to enroll or already enrolled in the DP3 main study 6. Informed consent signed 7. Not used to regular physical activity 8. Non-competitive medical certificate signed before starting the NW program
Exclusion criteria
Exclusion criteria: 1. Previous diagnosis of prostate cancer 2. Previous (in the last 5 years) or current diagnosis of malignant cancer 3. Immunosuppressive therapy for transplant Only for the NW ancillary study: 4. Impossibility of carrying out physical activity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood sampling is performed at baseline and: every 6 months, for at least three times, in men without any prostate cancer suspicion; at each recall in men with prostate cancer suspicion; before prostatectomy and at each follow-up up to three years after radical prostatectomy in men who undergo surgery. Plasma only is isolated at every time point after baseline. 1. Serum, plasma and PBMCs are isolated within 1 hour after blood sampling at baseline using centrifugation and Ficoll gradient separation 2. Plasma is isolated at every time point after baseline using centrifugation of EDTA K2 tubes at 2500 rpm for 10 min at 4°C, repeated twice 3. Serum is isolated at baseline using centrifugation of serum-specific tubes at 2500 rpm for 10 min at 4°C 4. PBMCs are isolated at baseline using Ficoll gradient separation 5. Urine supernatant and pellet are isolated at baseline or before fusion biopsy using centrifugation at 15000 rpm for 30 min at 4°C 6. PSA concentration is measured using Elecsys total PSA kit IVD at baseline and at each follow-up time point 7. Plasma circulating levels of miR-103a-3p, miR-5100, and let-7a-5p are measured using RT-qPCR and Taqman assays at baseline and after prostatectomy in men diagnosed with prostate cancer and treated surgically 8. Plasma circulating sphingolipids are measured using targeted lipidomics via mass spectrometry at baseline and after prostatectomy in men diagnosed with prostate cancer and treated surgically 9. Plasma circulating proteome is measured using the Olink Explore HT platform at baseline, after prostatectomy in men diagnosed with prostate cancer and treated surgically, and after 6 months in men enrolled in the NW ancillary study 10. Transcriptomic profile of PBMCs is measured using total RNA sequencing at baseline 11. Transcriptomic profile of fixed prostate tissue is measured using total RNA sequencing in men with intermediate-risk prostate tumors (ISUP grade 2–3) 12. Urinary microbiota is measured | — |
Secondary
| Measure | Time frame |
|---|---|
| These measures are carried out in the ancillary study only: 1. Sedentary behavior is measured using the Global Physical Activity Questionnaire (GPAQ) at baseline, 6 months, and 1 year (for NW group only) 2. Physical activity in occupational, transport-related, and leisure-time contexts is measured using the Global Physical Activity Questionnaire (GPAQ) at baseline, 6 months, and 1 year (for NW group only) 3. Weekly level of moderate to vigorous physical activity (MVPA) is measured using metabolic equivalents (METs) derived from GPAQ data at baseline, 6 months, and 1 year (for NW group only) 4. Psycho-physical health and quality of life are measured using the SF-12 questionnaire at baseline, 6 months, and 1 year (for NW group only) 5. Height, weight, and hip and waist circumferences are measured using anthropometric assessment at baseline, 6 months, and 1 year (for NW group only) 6. Body mass index (BMI) is calculated from height and weight measurements at baseline, 6 months, and 1 year (for NW group only) 7. Blood pressure, O2 saturation level, and resting heart rate are measured using clinical assessment at baseline, 6 months, and 1 year (for NW group only) 8. Upper limb strength is measured using the Handgrip Test at baseline, 6 months, and 1 year (for NW group only) 9. Dynamic balance, mobility, and fall risk are measured using the Timed-Up-and-Go Test at baseline, 6 months, and 1 year (for NW group only) 10. Lower limb strength and endurance are measured using the 30’’ Sit-to-Stand Test at baseline, 6 months, and 1 year (for NW group only) 11. Aerobic capacity and endurance are measured using the 6 Minute Walking Test (6WT) at baseline, 6 months, and 1 year (for NW group only) 12. Rating of perceived exertion (RPE) is measured using subjective self-assessment during the 6 Minute Walking Test at baseline, 6 months, and 1 year (for NW group only) 13. Body roundness index (BRI) is calculated using waist circumference and height measurements | — |
Countries
Italy
Contacts
Public ContactFrancesca Crivelli
Outcome results
None listed