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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorFondazione del Piemonte per l'Oncologia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age > 18 years

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

Disqualifiers

None

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

400 Participants
are grouped into 3 trial groups
Group A: Cohort A:patients with high risk localized prostate cancer
Group B: Cohort B: patients with de novo metastatic hormone sensitive prostate cancer (mHSPC)
Group C: Cohort C:Patients with metastatic castration resistant prostate cancer (mCRPC) progressing

Trial outcomes

Primary outcomes

1

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

Time frame
24 months
2

Changes in PSA levels in the 3 cohorts

Evaluation of PSA levels (baseline versus follow-up) in the 3 cohorts compared with radiological assessment

Time frame
36 months

Secondary outcomes

1

Number of patient-derived preclinical models

Number of patient-derived preclinical models (primary 2D cell lines, organoids or PDXs)

Time frame
36 months

Other outcomes

Sponsors and contacts

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