INSIDE: Identification of Genomic Screening Pathways in Cancer Patients With DNA Repair Alterations

Prostate Cancer Clinical Trial

— INSIDE  

Official title:

Identification of Genomic Screening Pathways in Cancer Patients With DNA Repair Alterations

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06334809
• Other study ID #: 028FPO22
• Status: Recruiting
• Start date: March 9, 2023
• Est. completion date: December 31, 2027

Study information

• Verified date: March 2024
• Source: Fondazione del Piemonte per l'Oncologia
• Contact: ilaria Buondonno, PhD
• Phone: +390119933393
• Email: ilaria.buondonno[@]ircc.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
Italy	Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo	Candiolo	Turin
Italy	AOU San Luigi Gonzaga	Orbassano	Turin

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione del Piemonte per l'Oncologia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number, type and frequency of DDR and MMR germline/somatic alterations	Evaluation of the frequency, number and type of DDR and MMR germline/somatic alterations in the study population	24 months
Primary	Changes in PSA levels in the 3 cohorts	Evaluation of PSA levels (baseline versus follow-up) in the 3 cohorts compared with radiological assessment	36 months
Secondary	Number of patient-derived preclinical models	Number of patient-derived preclinical models (primary 2D cell lines, organoids or PDXs)	36 months