Ignite Creation Date:
2024-05-06 @ 3:44 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04746300
Status:
RECRUITING
Last Update Posted:
2021-02-09
First Post:
2021-01-28
Brief Title:
imPlementing ROutine Molecular Characterization in Patients With Metastatic Castration Resistant ProstaTe Cancer by NGS
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
imPlementing ROutine Molecular Characterization in Patients With Metastatic Castration-resistant ProsTate Cancer by Next Generation DNA Sequencing PROMPT-study
Status:
RECRUITING
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROMPT
Brief Summary:
The PROMPT study aims to routinely implement genomic pre-sorting of metastatic castration-resistant prostate cancer mCRPC patients for personalized treatment eg immuno- PARP inhibitors or platinum-therapy The investigators hypothesize that by doing this early in the disease course before exhausting standard of care options it will improve treatment planning patient outcome quality of life and reduce costs
Detailed Description:
Prostate cancer is a major health problem leading to significant morbidity and mortality in men worldwide Approved therapies for metastatic castration-resistant prostate cancer mCRPC include abiraterone and enzalutamide targeting the androgen signaling pathway radium-223 bone targeting radionuclide therapy and taxane chemotherapy Controversy remains on optimal sequencing of available therapeutic agents and these drugs are still commonly prescribed in a trial-and-error manner Only a minority of patients receives the full benefit of the anticancer armamentarium but all experience unnecessary side-effects quality of life deterioration and delay in onset to adequate life-prolonging treatment In addition the prescription of ineffective drugs and avoidable hospital admissions contribute to the financial burden of health care systems
In recent years distinct molecular subsets of prostate cancer have been identified in mCRPC These molecular defects may guide physicians in proper sequencing of medication and in predicting the individual response more accurately In previous studies using next-generation sequencing NGS mCRPC patients could be grouped into clearly distinct molecular subtypes Moreover in these subtypes biomarkers associated with resistance to certain therapies or biomarkers actually predictive for enhanced response were identified
In this study the investigators will introduce routine molecular characterization in participants with mCRPC as early as possible in their disease state Participants will be screened before initiation of second-line treatment since early identification will maximize clinical and financial benefit Following screening participants will be discussed in molecular tumor board and clinical meetings and stratified to the agent they are most likely to respond to Translational research is included to identify and validate additional predictive molecular biomarkers
In recent years distinct molecular subsets of prostate cancer have been identified in mCRPC These molecular defects may guide physicians in proper sequencing of medication and in predicting the individual response more accurately In previous studies using next-generation sequencing NGS mCRPC patients could be grouped into clearly distinct molecular subtypes Moreover in these subtypes biomarkers associated with resistance to certain therapies or biomarkers actually predictive for enhanced response were identified
In this study the investigators will introduce routine molecular characterization in participants with mCRPC as early as possible in their disease state Participants will be screened before initiation of second-line treatment since early identification will maximize clinical and financial benefit Following screening participants will be discussed in molecular tumor board and clinical meetings and stratified to the agent they are most likely to respond to Translational research is included to identify and validate additional predictive molecular biomarkers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NL6831509119 | REGISTRY | ABR registry | None |