Identification of Genomic Screening Pathways in Cancer Patients With DNA Repair Alterations
Status: Recruiting
Location: See all (2) locations...
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Italy
Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo
RECRUITING
Candiolo
AOU San Luigi Gonzaga
RECRUITING
Orbassano
Contact Information
Primary
ilaria Buondonno, PhD
ilaria.buondonno@ircc.it
+390119933393
Backup
Marco Asioli
ufficio.trials@ircc.it
+390119933463
Time Frame
Start Date:2023-03-09
Estimated Completion Date:2027-12-31
Participants
Target number of participants:400
Treatments
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.