Prostate Cancer
Conditions
Keywords
prostate cancer, mHSPC, castration-resistant, PARP inhibitory, mCRPC
Brief summary
400 patients will be enrolled and divided into 3 cohorts: Cohort A: patients with high risk localized prostate cancer (PC) defined as \>cT3 or PSA \> 20 ng/mL or presence of ECE or SVI at mpMRI; Cohort B: patients with de novo metastatic hormone sensitive prostate cancer (mHSPC); Cohort C: patients with metastatic castration resistant prostate cancer (mCRPC) progressing on a standard treatment.
Detailed description
In this study 150 patients will be enrolled in cohort A, 100 patients in cohort B and 100-150 patients in Cohort C. Considering the known frequency of DDR and MMR germline/somatic alterations, it is expected to see: * 15-23 patients with germline/somatic DDR defects and 5-7 MMR alterations in cohort A; * 20-25 patients with germline/somatic DDR defects and 5-7 MMR alterations in cohort B; * 25-35 patients with germline/somatic DDR defects and 7-10 MMR alterations in cohort C. Patients within Cohort A will be followed up with PSA every 3 months for 3 years and early scans. They will also receive a blood sample for ctDNA/CTC before (when feasible) and after radical treatment, 6 months and 12 months (if not progressed), at time of PSA or radiological progression; Patients within Cohort B will be followed up with PSA and scans every 3 months. They will also receive a blood sample before (when feasible) or after the start of systemic treatment, 6 months and 12 months (if not progressed), at time of PSA or radiological progression. Patients within Cohort C will be followed up with PSA monthly and scans every 3 month. They will also receive a blood sample for ctDNA/CTC before (when feasible) or after the start of systemic treatment, 6 months and 12 months (if not progressed), at time of PSA or radiological progression.
Interventions
None listed
Sponsors
Fondazione del Piemonte per l'Oncologia
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years * Diagnosis of prostate cancer as indicated below: Cohort A: patients with high risk localized prostate cancer (defined as \>cT3 or PSA \> 20 ng/mL or presence of ECE or SVIat mpMRI), with tissue available from diagnostic biopsy/ prostatectomy undergoing or who underwent curative treatment (prostatectomy/ radical radiotherapy) but have not started a FU pathway. Cohort B: patients with de novo metastatic hormone sensitive prostate cancer (mHSPC) with tissue available from diagnostic biopsy of the primary and when possiblepossible, from a metastatic site. Patients must either have not started a standard treatment or have started for not longer than 3 months. Cohort C: patients with metastatic castration resistant prostate cancer tissue (mCRPC) progressing on a standard treatment with available from biopsy of a metastatic site, and when possiblepossible, from the primary. * Ability to understand and consent to informed consent; * Patient must be compliant with receiving a biopsy of the metastatic site (cohort C) and with FU assessments schedule
Exclusion criteria
• Patients not willing to comply with study's procedures or fulfilling the inclusion criteria.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number, type and frequency of DDR and MMR germline/somatic alterations | 24 months | Evaluation of the frequency, number and type of DDR and MMR germline/somatic alterations in the study population |
| Changes in PSA levels in the 3 cohorts | 36 months | Evaluation of PSA levels (baseline versus follow-up) in the 3 cohorts compared with radiological assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patient-derived preclinical models | 36 months | Number of patient-derived preclinical models (primary 2D cell lines, organoids or PDXs) |
Countries
Italy
Contacts
Primary Contactilaria Buondonno, PhD
Backup ContactMarco Asioli
Outcome results
None listed