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Trial record 2 of 2 for:    PRIMARY2 | Prostate Cancer
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INSIDE: Identification of Genomic Screening Pathways in Cancer Patients With DNA Repair Alterations (INSIDE)

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ClinicalTrials.gov Identifier: NCT06334809
Recruitment Status : Recruiting
First Posted : March 28, 2024
Last Update Posted : March 28, 2024
Sponsor:
Information provided by (Responsible Party):
Fondazione del Piemonte per l'Oncologia

Study Description
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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.


Condition or disease
Prostate Cancer

Detailed 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.

Study Design
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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Identification of Genomic Screening Pathways in Cancer Patients With DNA Repair Alterations
Actual Study Start Date : March 9, 2023
Estimated Primary Completion Date : December 31, 2026
Estimated Study Completion Date : December 31, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. Number, type and frequency of DDR and MMR germline/somatic alterations [ Time Frame: 24 months ]
    Evaluation of the frequency, number and type of DDR and MMR germline/somatic alterations in the study population

  2. Changes in PSA levels in the 3 cohorts [ Time Frame: 36 months ]
    Evaluation of PSA levels (baseline versus follow-up) in the 3 cohorts compared with radiological assessment


Secondary Outcome Measures :
  1. Number of patient-derived preclinical models [ Time Frame: 36 months ]
    Number of patient-derived preclinical models (primary 2D cell lines, organoids or PDXs)


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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06334809


Contacts
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Contact: ilaria Buondonno, PhD +390119933393 ilaria.buondonno@ircc.it
Contact: Marco Asioli +390119933463 ufficio.trials@ircc.it

Locations
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Italy
Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo Recruiting
Candiolo, Turin, Italy, 10060
Contact: Pasquale Rescigno, MD       pasquale.rescigno@ircc.it   
Contact: Ilaria Buondonno, PhD    +390119933393    ilaria.buondonno@ircc.it   
AOU San Luigi Gonzaga Recruiting
Orbassano, Turin, Italy, 10060
Contact: Francesco Porpiglia, MD         
Sponsors and Collaborators
Fondazione del Piemonte per l'Oncologia
Investigators
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Principal Investigator: Pasquale Rescigno, MD Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo
More Information
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Responsible Party: Fondazione del Piemonte per l'Oncologia
ClinicalTrials.gov Identifier: NCT06334809    
Other Study ID Numbers: 028FPO22
First Posted: March 28, 2024    Key Record Dates
Last Update Posted: March 28, 2024
Last Verified: March 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fondazione del Piemonte per l'Oncologia:
prostate cancer
mHSPC
castration-resistant
PARP inhibitory
mCRPC
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases