Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04983628
Other study ID # TR_9/21
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 1, 2020
Est. completion date August 1, 2023

Study information

Verified date March 2022
Source Hellenic Cooperative Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

We aim to employ targeted DNA NGS to evaluate the prevalence of germline and somatic mutations in cancer predisposing genes, such as BRCA1 and BRCA2, and other HR and DDR genes, including also a few additional clinically relevant genes, in patients with metastatic, locally advanced or high-grade prostate cancer. In addition, we will investigate the prognostic role of these mutations as well as their association with various clinicopathological parameters. This will be the first study investigating the prevalence of germline and somatic pathogenic mutations in Greek patients with prostate cancer.


Description:

This study will include formalin-fixed paraffin-embedded tumor tissue (FFPE) from 250 patients with metastatic, recurrent, locally advanced or "intermediate or high risk" (Gleason >7), operable prostate cancer. FFPE tumor blocks alongside peripheral blood will be retrieved for all patients from Pathology Laboratories. Available FFPE blocks will be subjected to histological review by an experienced pathologist to evaluate H&E sections for confirmation of diagnosis, histologic type, grade and tumor cell content (TCC%), as well as mark tumor dense areas for manual macro-dissection, prior to DNA extraction, in order to enrich samples for tumor DNA. Clinicopathologic characteristics of patients with prostate cancer will be retrieved from their respective medical records. Diagnosis will be confirmed through pathology reports, which will also provide information about Gleason Score and histological subtype. In all instances, the collection of patient information will be in compliance with the regulations of the Bioethics committees of participating Hospitals. The study will be conducted in accordance with the principles of the Helsinki Declaration of Human Rights. Following manual macro-dissection, FFPE tumor tissue material will be processed for DNA extraction, according to standard procedures with the QIAamp DNA Mini Kit (Qiagen GmbH, Hilden, Germany). Sequencing will be performed at the Laboratory of Molecular Oncology, using an Ion Torrent Proton Sequencer (Life Technologies/Ion Torrent). For the purpose of targeted NGS genotyping of tumor and available matched germline DNA samples, we designed a custom Ampliseq panel to target coding relevant regions of genes involved in homologous recombination (HR), along with several others. Data retrieval and base calling will be performed on the Torrent Server (v5.8.0.8). Consequently, we will then employ appropriate Ion Reporter Workflows (version 5.10) to automatically annotate single nucleotide variants (SNVs), multiple nucleotide variants (MNVs), small insertions / deletions (INDELs) and copy number variations (CNVs).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 250
Est. completion date August 1, 2023
Est. primary completion date January 30, 2023
Accepts healthy volunteers
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - metastatic prostate cancer - recurrent prostate cancer - locally advanced prostate cancer - "intermediate or high risk" (Gleason >7), operable prostate cancer - available FFPE tumor tissue Exclusion Criteria: - absence of tumor tissue available for analysis

Study Design


Intervention

Other:
Tumor molecular profiling
targeted DNA NGS

Locations

Country Name City State
Greece Hellenic Cooperative Oncology Group Athens

Sponsors (1)

Lead Sponsor Collaborator
Hellenic Cooperative Oncology Group

Country where clinical trial is conducted

Greece, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of germline and somatic mutations in cancer predisposing genes Number of patients with either germline or somatic mutations 1 year
Secondary Overall survival Time from diagnosis to the date of death, through the completion of the study 3 years
See also
  Status Clinical Trial Phase
Completed NCT04400656 - PROState Pathway Embedded Comparative Trial
Suspended NCT05361915 - Study to Assess Abivertinib in Combination With Abiraterone in Metastatic Castration Resistant Prostate Cancer Phase 2
Recruiting NCT05067140 - A Study of ARV-766 Given by Mouth in Men With Metastatic Prostate Cancer Phase 1/Phase 2
Completed NCT03646162 - Study of VERU-944 to Ameliorate Hot Flashes in Men With Advanced Prostate Cancer Phase 2
Active, not recruiting NCT03413995 - Trial of Rucaparib in Patients With Metastatic Hormone-Sensitive Prostate Cancer Harboring Germline DNA Repair Gene Mutations Phase 2
Recruiting NCT05078151 - Whole-Body Diffusion-Weighted Magnetic Resonance Imaging (MRI) as a Response Biomarker for Metastatic Prostate Cancer N/A
Recruiting NCT03507595 - Evaluation of the Metastasis and Recurrence of Prostate Cancer
Completed NCT03362359 - Ga-68-PSMA-11 in High-risk Prostate Cancer Phase 1/Phase 2
Recruiting NCT04116775 - Fecal Microbiota Transplant and Pembrolizumab for Men With Metastatic Castration Resistant Prostate Cancer. Phase 2
Completed NCT03223727 - Treatment Outcomes in a Non-study Population of Symptomatic mCRPC Patients Treated With Radium-223
Recruiting NCT04983095 - Metastasis Directed Stereotactic Body Radiotherapy for Oligo Metastatic Hormone Sensitive Prostate Cancer Phase 3
Recruiting NCT04086290 - National Danish Protocol. Surgery+ SBRT for M1 Prostate Cancer Patients Phase 1/Phase 2
Recruiting NCT03129139 - A Phase 1, Multi-Center, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Minnelideā„¢ Capsules Given Alone or in Combination With Protein-Bound Paclitaxel in Patients With Advanced Solid Tumors Phase 1
Active, not recruiting NCT03414437 - Post-eRADicAte - A Long Term Follow up of Subjects That Completed the eRADicAte Study (NCT 02097303)
Completed NCT02485691 - Cabazitaxel Versus the Switch to Alternative AR-targeted Agent (Enzalutamide or Abiraterone) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Patients Previously Treated With Docetaxel and Who Rapidly Failed a Prior AR-targeted Agent Phase 4
Completed NCT03693742 - MSG Use With 18F-DCFPyL PET/CT Imaging N/A
Completed NCT01322490 - A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F +/- GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic Castrate-Resistant Prostate Cancer Phase 3
Completed NCT03739684 - Study of 18F-DCFPyL PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer Phase 3
Recruiting NCT05655715 - Checkpoint Inhibitors and SBRT for mCRPC Phase 2
Recruiting NCT03784755 - Local Ablative Therapy For Hormone Sensitive Oligometastatic Prostate Cancer N/A