Ignite Creation Date:
2024-05-06 @ 3:13 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04556916
Status:
RECRUITING
Last Update Posted:
2022-01-04
First Post:
2020-06-23
Brief Title:
Early Detection of Prostate Cancer
Sponsor:
University Hospital Montpellier
Organization:
University Hospital Montpellier
Study Overview
Official Title:
Early Detection of Prostate Cancer by Liquid Biopsy
Status:
RECRUITING
Status Verified Date:
2021-12
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:
PROLIPSY
Brief Summary:
This study is the early detection of prostate cancer by analysing circulating bloodbased biomarkers Based on our latest developments we primarily aim to assess the validity of CTCs circulating tumour cells and tumour cell products circulating in blood DNA exosomes for early PCa Prostate cancer detection
In the first discovery period the investigators will assess which Liquid biopsy marker will provide the best discrimination between the patients with histologically proven PCa and age-matched noncancer controls Further subset analysis with special emphasis on the identification of high risk PCa patients with aggressive tumours as defined by a Gleason score gold standard of 8 or higher ISUP 4 and higher will be performed The resulting biomarker candidates will then be further explored in the subsequent training and validation study years 2 and 3 in order to obtain the single blood test or combination of tests with the highest sensitivity and specificity for detection of early PCa andor high-risk PCa The investigators will also compare these new biomarkers with recently FDA cleared CE-IVD assays for early detection of prostate cancer based on classic peripheral tumour markers such as Prostate Health Index PHI and PCA3 Follow up evaluations will be initiated to assess the prognostic relevance of the candidate biomarkers determined in this project Here the investigators will set up the data management system including all relevant information on the tissues collected and the results of the analyses as well as the clinical data of the patients investigated in this study
In the first discovery period the investigators will assess which Liquid biopsy marker will provide the best discrimination between the patients with histologically proven PCa and age-matched noncancer controls Further subset analysis with special emphasis on the identification of high risk PCa patients with aggressive tumours as defined by a Gleason score gold standard of 8 or higher ISUP 4 and higher will be performed The resulting biomarker candidates will then be further explored in the subsequent training and validation study years 2 and 3 in order to obtain the single blood test or combination of tests with the highest sensitivity and specificity for detection of early PCa andor high-risk PCa The investigators will also compare these new biomarkers with recently FDA cleared CE-IVD assays for early detection of prostate cancer based on classic peripheral tumour markers such as Prostate Health Index PHI and PCA3 Follow up evaluations will be initiated to assess the prognostic relevance of the candidate biomarkers determined in this project Here the investigators will set up the data management system including all relevant information on the tissues collected and the results of the analyses as well as the clinical data of the patients investigated in this study
Detailed Description:
In this preclinical validation study patients suspicious of prostate cancer who will undergo initial prostate biopsy are going to be asked for blood samples during a routine visit Each patient will have had an MRI Magnetic Resonance Imaging as part of the care before performing the biopsy The investigators will draw a total of 49 ml peripheral blood from consented patients before the initial diagnostic biopsy is taken Within this project validation of liquid biopsy assays for early detection of prostate cancer patients is the primary goal
In order to determine CTC numbers 21 ml of blood will be subjected to either CTC-Capture and 28 ml for the EPIDROP analysis according to standard protocol For analysis of circulating blood products plasma analysis of tumor specific mutations or promotor methylation analysis of extracellular vesicles and microRNA The investigators will also analyze the Prostate Health Index marker from the additional EDTA tube 7 ml
The investigators will assess whether CTC counts andor detection of tumor specific blood products will provide discrimination between the men with histologically proven prostate cancer and agematched non-cancer controls as well as identification of high-risk PCa patients
Furthermore the investigators will compare results from tested liquid biopsy assay with current standard of early prostate cancer detection using both serum PSA and digital rectal examination MRImp and PSA density
The discovery phase is a non-blind study on 70 subjects with elevated PSA and 50 negative controls Healthy patients no suspicion of prostate cancer PSA25 The 70 patients are patients with suspected prostate cancer and will undergo prostate biopsy
The samples will be tested for the 3 biomarkers CTCs cfDNA exosome The validation study is a non-blind study on 167 subjects with elevated PSA and designated for a biopsy this biopsy may be positive presence of cancer or negative no cancer revealed by the biopsy and 33 negative controls The samples will be tested with the best biomarkers or biomarker combination selected in the discovery phase
In order to determine CTC numbers 21 ml of blood will be subjected to either CTC-Capture and 28 ml for the EPIDROP analysis according to standard protocol For analysis of circulating blood products plasma analysis of tumor specific mutations or promotor methylation analysis of extracellular vesicles and microRNA The investigators will also analyze the Prostate Health Index marker from the additional EDTA tube 7 ml
The investigators will assess whether CTC counts andor detection of tumor specific blood products will provide discrimination between the men with histologically proven prostate cancer and agematched non-cancer controls as well as identification of high-risk PCa patients
Furthermore the investigators will compare results from tested liquid biopsy assay with current standard of early prostate cancer detection using both serum PSA and digital rectal examination MRImp and PSA density
The discovery phase is a non-blind study on 70 subjects with elevated PSA and 50 negative controls Healthy patients no suspicion of prostate cancer PSA25 The 70 patients are patients with suspected prostate cancer and will undergo prostate biopsy
The samples will be tested for the 3 biomarkers CTCs cfDNA exosome The validation study is a non-blind study on 167 subjects with elevated PSA and designated for a biopsy this biopsy may be positive presence of cancer or negative no cancer revealed by the biopsy and 33 negative controls The samples will be tested with the best biomarkers or biomarker combination selected in the discovery phase
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 |
|---|---|---|---|
| 2019-A02253-54 | OTHER | IDRCB | None |