INSIDE: Identification of Genomic Screening Pathways in Cancer Patients With DNA Repair Alterations
- Conditions
- Prostate Cancer
- Registration Number
- NCT06334809
- Lead Sponsor
- Fondazione del Piemonte per l'Oncologia
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 400
- 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
• Patients not willing to comply with study's procedures or fulfilling the inclusion criteria.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Number of patient-derived preclinical models 36 months Number of patient-derived preclinical models (primary 2D cell lines, organoids or PDXs)
Trial Locations
- Locations (2)
Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo
🇮🇹Candiolo, Turin, Italy
AOU San Luigi Gonzaga
🇮🇹Orbassano, Turin, Italy