Personalized prostate cancer prevention and management
| ISRCTN | ISRCTN86138886 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86138886 |
| Secondary identifying numbers | DPPP12345 |
- Submission date
- 02/10/2025
- Registration date
- 03/10/2025
- Last edited
- 03/10/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
The DP3 study is investigating how lifestyle, health history, and new blood biomarkers (particularly lipids and proteins) can improve prostate cancer (PCa) screening. Current PSA testing often leads to unnecessary invasive procedures, such as biopsies. By combining PSA with lifestyle and molecular data, we aim to better identify men who are at higher or lower risk.
As part of DP3, we also launched a Nordic Walking (NW) ancillary study to test whether regular supervised exercise can improve fitness, body composition, cardiometabolic health, PSA levels, and blood biomarkers in sedentary men.
Who can participate?
Men aged 50 years or older who are undergoing PSA testing as part of routine health care or prostate cancer screening in participating centers in the Piedmont region of Italy.
What does the study involve?
Participants provide detailed information on lifestyle, family and medical history, and undergo physical fitness assessments, anthropometric measures, and questionnaires on well-being. Blood samples are collected for PSA and biomarker testing.
In the NW substudy, men are invited to join a supervised Nordic Walking program (twice per week, up to 12 months). A comparison group continues with usual lifestyle.
What are the possible benefits and risks of participating?
Benefits may include improved physical fitness, weight control, blood pressure regulation, and overall well-being. Blood and molecular testing may provide useful information for future prevention strategies. Risks are minimal, limited to possible mild discomfort from blood draws and physical activity (e.g. muscle soreness).
Where is the study run from?
The study is coordinated at the Fondazione Edo ed Elvo Tempia in Biella (Italy) and involves collaborating hospitals in Piedmont.
When is the study starting and how long is it expected to run for?
Recruitment began in 2021. Participants are followed for at least 18 months, with ongoing long-term follow-up planned. The NW study started in 2023 and ended in 2025.
Who is funding the study?
The study is investigator-initiated and supported by institutional and regional resources, with no commercial sponsorship. The DP3 study is funded by Compagnia di San Paolo, Fondazione CRT, Rete Oncologica del Piemonte e della Valle d'Aosta, Banca d'Italia. The NW study is funded by Reale Foundation.
Who is the main contact?
Dr Giovanna Chiorino, giovanna.chiorino@fondazionetempia.org
Contact information
Scientific
Via Malta 3
Biella
13900
Italy
 ORCID ID |
0000-0002-9502-6400 |
|---|---|
| Phone | +39 (0)3475899751 |
| giovanna.chiorino@fondazionetempia.org |
Principal investigator
via dei Ponderanesi 3
Ponderano
13875
Italy
| ORCID ID |
0000-0001-8482-3458 |
|---|---|
| Phone | +39 (0)3272592497 |
| stefano.zaramella@aslbi.piemonte.it |
Public
via dei Ponderanesi 3
Ponderano (Biella)
13875
Italy
| Phone | +39 (0)3343337504 |
|---|---|
| francesca.crivelli@aslbi.piemonte.it |
Study information
| Study design | Prospective observational trial with ancillary real-world longitudinal study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Diagnosis and prognosis prediction of prostate cancer: an integrated model between biology and technology |
| Study acronym | DP3 |
| Study objectives | The objectives of the main study DP3 are to evaluate molecular biomarkers in combination with clinical, lifestyle, and anamnestic data to personalize prostate cancer (PCa) screening strategies in men aged >50 years old men and to predict prostate cancer aggressiveness, especially for intermediate risk tumors. Given the significant association between physical activity and recall rate reduction and the paucity of data on adherence-dependent effects of structured exercise in PCa screening populations, we designed an ancillary study of DP3. This is a real-world prospective study to assess whether different degrees of participation in a supervised NW program could translate into measurable improvements in fitness, cardiometabolic health, and prostate-related outcomes. The primary objective of the ancillary study is to determine whether regular participation of sedentary men over 50 in supervised NW leads to improvements in physical fitness, anthropometric measures, cardiometabolic risk factors, mental well-being, and PSA levels over 6-12 months. We hypothesize that greater adherence to NW sessions is associated with larger health benefits. Therefore, the study is not a randomized intervention study with a strict protocol but a real-world study where participants are free to adhere to the NW sessions according to their possibilities. Controls are randomly chosen men recruited for the DP3 study who agree to participate in the ancillary study and whose characteristics are comparable with those of the NW group in terms of age, PSA, family history of cancer, and physical activity. A secondary, exploratory objective is to evaluate whether NW induces detectable systemic changes in circulating protein profiles. |
| Ethics approval(s) |
Approved 07/09/2020, Comitato Etico Territoriale Interaziendale AOU Maggiore della Carità (Corso Mazzini 18, Novara, 28100, Italy; +39 (0)3213733081; comitatoetico@maggioreosp.novara.it), ref: Prot. N°968/CE 07/09/2020, integrations Prot. N°263/CE, 10/03/2021 and Prot. N°250/CE, 21/03/2023 specific for the NW ancillary study |
| Health condition(s) or problem(s) studied | Prostate cancer |
| Intervention | 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, anthropometric measures, and questionnaires on lifestyle, well-being, and disease risk factors are collected at baseline, 6, and 12 months. |
| Intervention type | Behavioural |
| Primary outcome measure | 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 using Pathochip arrays (Agilent) starting from DNA and RNA isolated from urine sediments at baseline or before fusion biopsy 13. Lifestyle factors including physical activity, BMI, diet, smoking and alcohol consumption are measured using self-reported questionnaires at baseline 14. Familial history, past prostate biopsies and concurrent pathologies are measured using self-reported questionnaires at baseline 15. PSA levels and digital rectal examination outcomes are measured using clinical records and urological visit reports at baseline and at each follow-up time point 16. Histological and clinical information for prostate tumors is recorded using pathology reports and clinical records at each follow-up time point 17. Electronic Case Report Forms (eCRF) including questionnaires, urological visit reports, PSA dosage and lab analyses are uploaded to a password-protected online database (https://www.keyform.eu) at each follow-up time point |
| Secondary outcome measures | 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 at baseline, 6 months, and 1 year (for NW group only) 14. A Body Shape Index (ABSI) is calculated using waist circumference, BMI, and height measurements at baseline, 6 months, and 1 year (for NW group only) 15. Conicity index is calculated using waist circumference, weight, and height measurements at baseline, 6 months, and 1 year (for NW group only) 16. Plasma circulating proteome is measured using the Olink Explore HT platform at baseline and after 6 months (for NW group only) |
| Overall study start date | 01/12/2019 |
| Completion date | 30/06/2028 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Senior |
| Lower age limit | 50 Years |
| Upper age limit | 79 Years |
| Sex | Male |
| Target number of participants | 1500 for the main study and at least 30 per group for the ancillary NW study |
| Key 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 |
| Key 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 |
| Date of first enrolment | 22/02/2021 |
| Date of final enrolment | 31/12/2026 |
Locations
Countries of recruitment
- Italy
Study participating centres
Biella
13900
Italy
Ponderano
13875
Italy
Torino
10126
Italy
Sponsor information
Research organisation
Via Malta 3
Biella
13900
Italy
| Website | http://www.fondazionetempia.org/ |
|---|---|
"ROR" |
https://ror.org/01x5t2m44 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- San Paolo Company, San Paolo Company Foundation, Compagnia San Paolo, Fondazione Compagnia di San Paolo, CSP, FCSP
- Location
- Italy
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- CRT Foundation
- Location
- Italy
Government organisation / Other non-profit organizations
- Alternative name(s)
- Oncology Network of Piedmont and Valle d'Aosta
- Location
- Italy
Government organisation / National government
- Alternative name(s)
- Bank of Italy
- Location
- Italy
No information available
Results and Publications
| Intention to publish date | 31/10/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Peer-reviewed journals. The first results of the DP3 study have already been published: https://translational-medicine.biomedcentral.com/articles/10.1186/s12967-025-06820-9 |
| IPD sharing plan | The data published in Journal of Translational Medicine are available from the corresponding author upon request; the data of the NW ancillary study are deposited at the following link: https://doi.org/10.5281/zenodo.16100008. The studies did not include the use of custom codes. The future data obtained from proteomics analyses will be stored in a publicly available repository (Zenodo). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Dataset | 26/07/2025 | 02/10/2025 | No | No | |
| Interim results article | 14/07/2025 | 02/10/2025 | Yes | No | |
| Statistical Analysis Plan | 03/10/2025 | No | No |
Additional files
Editorial Notes
02/10/2025: Study's existence confirmed by the Comitato Etico Territoriale Interaziendale AOU Maggiore della Carità.
