Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06600802
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-22
Brief Title:
Intrinsic Validity of Molecular Markers Detection on Tissular Tumoral DNA to Predict the Efficacy of 177Lutetium-PSMA-617 Lu-PSMA Treatment for Castration-resistant Metastatic Prostate Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Intrinsic Validity of Molecular Markers Detection on Tissular Tumoral DNA to Predict the Efficacy of 177Lutetium-PSMA-617 Lu-PSMA Treatment for Castration-resistant Metastatic Prostate Cancer PSMA-PRED
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PSMA-PRED
Brief Summary:
Prostate cancer is the most common cancer in men Its incidence is rising as the population ages In the localized stage the 5-year overall survival rate OS is 98 Metastatic progression and resistance to castration have a negative impact on prognosis Despite recent advances in management the 5-year OS is around 30 Therapeutic advances in this indication have been made mainly by the use of taxanes and second-generation hormone therapy These treatments have improved OS and progression-free survival PFS They are now used as standard therapy
More recently the Phase III VISION trial confirmed the improvement in OS and radiological PFS achieved by treatment with the radioligand 177Lutetium-PSMA-617 Lu-PSMA in patients with advanced metastatic castration-resistant prostate cancer mCRPC
This treatment is currently available in early access in France Despite encouraging results 40 of patients will not respond to Lu-PSMA and there are currently no validated predictive factors Studies are currently on going but the identification of biomarkers seems necessary to better stratify risk in these patients
Numerous tissue prognostic tests based on molecular characteristics or cell proliferation are emerging with this in mind At present molecular profiling is not a routine technique for prostate cancer as it is for other solid cancers At an early stage the Decipher Genomic classification tool has shown prognostic utility independently of therapeutic and clinico-pathological data
According to recent studies methylome analysis would enable the subdivision of mCRPCs and could help identify new therapeutic targets
In the metastatic phase certain molecular abnormalities involving DNA repair genes are predictive of response to PARP inhibitors
Molecular analysis mutations copy number alterations gene expression DNA methylation could therefore be useful in optimizing the management of mCRPC patients treated with Lu-PSMA
If reliable molecular abnormalities are identified on tissue a diagnostic technique based on circulating tumor DNA ctDNA analysis will be useful in decision-making for these patients A biological collection will therefore be created during the course of this study with a view to using ctDNA analysis in subsequent research
More recently the Phase III VISION trial confirmed the improvement in OS and radiological PFS achieved by treatment with the radioligand 177Lutetium-PSMA-617 Lu-PSMA in patients with advanced metastatic castration-resistant prostate cancer mCRPC
This treatment is currently available in early access in France Despite encouraging results 40 of patients will not respond to Lu-PSMA and there are currently no validated predictive factors Studies are currently on going but the identification of biomarkers seems necessary to better stratify risk in these patients
Numerous tissue prognostic tests based on molecular characteristics or cell proliferation are emerging with this in mind At present molecular profiling is not a routine technique for prostate cancer as it is for other solid cancers At an early stage the Decipher Genomic classification tool has shown prognostic utility independently of therapeutic and clinico-pathological data
According to recent studies methylome analysis would enable the subdivision of mCRPCs and could help identify new therapeutic targets
In the metastatic phase certain molecular abnormalities involving DNA repair genes are predictive of response to PARP inhibitors
Molecular analysis mutations copy number alterations gene expression DNA methylation could therefore be useful in optimizing the management of mCRPC patients treated with Lu-PSMA
If reliable molecular abnormalities are identified on tissue a diagnostic technique based on circulating tumor DNA ctDNA analysis will be useful in decision-making for these patients A biological collection will therefore be created during the course of this study with a view to using ctDNA analysis in subsequent research
Detailed Description:
Prostate cancer is the most common cancer in men Its incidence is rising as the population ages In the localized stage the 5-year overall survival rate OS is 98 Metastatic progression and resistance to castration have a negative impact on prognosis Despite recent advances in management the 5-year OS is around 30 Therapeutic advances in this indication have been made mainly by the use of taxanes and second-generation hormone therapy These treatments have improved OS and progression-free survival PFS They are now used as standard therapy
More recently the Phase III VISION trial confirmed the improvement in OS and radiological PFS achieved by treatment with the radioligand 177Lutetium-PSMA-617 Lu-PSMA in patients with advanced metastatic castration-resistant prostate cancer mCRPC
This treatment is currently available in early access in France Despite encouraging results 40 of patients will not respond to Lu-PSMA and there are currently no validated predictive factors Studies are currently on going but the identification of biomarkers seems necessary to better stratify risk in these patients
Numerous tissue prognostic tests based on molecular characteristics or cell proliferation are emerging with this in mind At present molecular profiling is not a routine technique for prostate cancer as it is for other solid cancers At an early stage the Decipher Genomic classification tool has shown prognostic utility independently of therapeutic and clinico-pathological data
According to recent studies methylome analysis would enable the subdivision of mCRPCs and could help identify new therapeutic targets
In the metastatic phase certain molecular abnormalities involving DNA repair genes are predictive of response to PARP inhibitors
Molecular analysis mutations copy number alterations gene expression DNA methylation could therefore be useful in optimizing the management of mCRPC patients treated with Lu-PSMA
If reliable molecular abnormalities are identified on tissue a diagnostic technique based on circulating tumor DNA ctDNA analysis will be useful in decision-making for these patients A biological collection will therefore be created during the course of this study with a view to using ctDNA analysis in subsequent research
This is an interventional multi-center study The study is prospective single-arm open-label and non-randomized
Its primary objective is to identify biomarkers of interest in primary tissue predictive of response to Lu-PSMA treatment in patients with mCRPC through the detection of molecular abnormalities in DNARNA and methyloma
More recently the Phase III VISION trial confirmed the improvement in OS and radiological PFS achieved by treatment with the radioligand 177Lutetium-PSMA-617 Lu-PSMA in patients with advanced metastatic castration-resistant prostate cancer mCRPC
This treatment is currently available in early access in France Despite encouraging results 40 of patients will not respond to Lu-PSMA and there are currently no validated predictive factors Studies are currently on going but the identification of biomarkers seems necessary to better stratify risk in these patients
Numerous tissue prognostic tests based on molecular characteristics or cell proliferation are emerging with this in mind At present molecular profiling is not a routine technique for prostate cancer as it is for other solid cancers At an early stage the Decipher Genomic classification tool has shown prognostic utility independently of therapeutic and clinico-pathological data
According to recent studies methylome analysis would enable the subdivision of mCRPCs and could help identify new therapeutic targets
In the metastatic phase certain molecular abnormalities involving DNA repair genes are predictive of response to PARP inhibitors
Molecular analysis mutations copy number alterations gene expression DNA methylation could therefore be useful in optimizing the management of mCRPC patients treated with Lu-PSMA
If reliable molecular abnormalities are identified on tissue a diagnostic technique based on circulating tumor DNA ctDNA analysis will be useful in decision-making for these patients A biological collection will therefore be created during the course of this study with a view to using ctDNA analysis in subsequent research
This is an interventional multi-center study The study is prospective single-arm open-label and non-randomized
Its primary objective is to identify biomarkers of interest in primary tissue predictive of response to Lu-PSMA treatment in patients with mCRPC through the detection of molecular abnormalities in DNARNA and methyloma
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None