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

NCT06334809 | Recruiting

• 1 other identifier: 028FPO22
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 2

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.

Conditions

Prostate Cancer

Keywords

prostate cancer; mHSPC; castration-resistant; PARP inhibitory; mCRPC

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Number of patient-derived preclinical models

  36 months

Study Arms (3)

Cohort A:patients with high risk localized prostate cancer

Cohort A:150 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. 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

Cohort B: patients with de novo metastatic hormone sensitive prostate cancer (mHSPC)

Cohort B: 100 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;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

Cohort C:Patients with metastatic castration resistant prostate cancer (mCRPC) progressing

Cohort C:100-150 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.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.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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

Sponsors & Collaborators

• Fondazione del Piemonte per l'Oncologia: lead

Study Sites (2)

Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo

Candiolo, Turin, 10060, Italy

RECRUITING

AOU San Luigi Gonzaga

Orbassano, Turin, 10060, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

will be collected: one test tube of ctDNA before the radical biomedical treatment, one will be collected after 6 and 12 months and at the time of progression. A representative sample of archival tumor tissue from diagnostic biopsy/prostatectomy and a biopsy of the metastasis will also be collected

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Pasquale Rescigno, MD

  Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo

  PRINCIPAL INVESTIGATOR

• Sabrina Arena, PhD

  Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ilaria Buondonno, PhD

CONTACT

+390119933393; ilaria.buondonno@ircc.it

Marco Asioli

CONTACT

+390119933463; ufficio.trials@ircc.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2024
• First Posted: March 28, 2024
• Study Start: March 9, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 12, 2025

Record last verified: 2025-06

Locations

IT (2)