Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06334809
Status:
RECRUITING
Last Update Posted:
2024-03-28
First Post:
2024-02-16
Brief Title:
INSIDE Identification of Genomic Screening Pathways in Cancer Patients With DNA Repair Alterations
Sponsor:
Fondazione del Piemonte per lOncologia
Organization:
Fondazione del Piemonte per lOncologia
Study Overview
Official Title:
Identification of Genomic Screening Pathways in Cancer Patients With DNA Repair Alterations
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INSIDE
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 ngmL 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
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 germlinesomatic alterations it is expected to see
15-23 patients with germlinesomatic DDR defects and 5-7 MMR alterations in cohort A
20-25 patients with germlinesomatic DDR defects and 5-7 MMR alterations in cohort B
25-35 patients with germlinesomatic 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 ctDNACTC 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 ctDNACTC 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
Considering the known frequency of DDR and MMR germlinesomatic alterations it is expected to see
15-23 patients with germlinesomatic DDR defects and 5-7 MMR alterations in cohort A
20-25 patients with germlinesomatic DDR defects and 5-7 MMR alterations in cohort B
25-35 patients with germlinesomatic 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 ctDNACTC 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 ctDNACTC 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None