Trial Radar AI | ||
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Clinical Trial NCT06334809 (INSIDE) for Prostate Cancer is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
INSIDE: Identification of Genomic Screening Pathways in Cancer Patients With DNA Repair Alterations 400
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.
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 germ...
Identification of Genomic Screening Pathways in Cancer Patients With DNA Repair Alterations
- INSIDE
- 028FPO22
mHSPC
castration-resistant
PARP inhibitory
mCRPC
| Participant Group/Arm | Intervention/Treatment |
|---|---|
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 wi...Show More | N/A |
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 sampl...Show More | N/A |
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 trea...Show More | N/A |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Number of patient-derived preclinical models | Number of patient-derived preclinical models (primary 2D cell lines, organoids or PDXs) | 36 months |
- 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
Fondazione del Piemonte per l'OncologiaTurin