INSIDE: Identification of Genomic Screening Pathways in Cancer Patients With DNA Repair Alterations
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Identification of Genomic Screening Pathways in Cancer Patients With DNA Repair Alterations
Overview
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.
Primary outcome measures
- Number, type and frequency of DDR and MMR germline/somatic alterations [Time frame: 24 months]
- Changes in PSA levels in the 3 cohorts [Time frame: 36 months]
Secondary outcome measures (1)
- Number of patient-derived preclinical models [Time frame: 36 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 2 centers
- Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo — Candiolo
- AOU San Luigi Gonzaga — Orbassano
Identifiers
NCT: NCT06334809 · 028FPO22