Ignite Creation Date:
2024-05-06 @ 3:11 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04541030
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-15
First Post:
2020-09-05
Brief Title:
Integrated Genomic Prostate Score With MRI Targeted Prostate Biopsies
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
UAB-NCI Collaborative Study on Integrating Genomic Prostate Score With MRI Targeted Prostate Biopsies
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06-10
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:
None
Brief Summary:
Background
Prostate cancer is one of the most common cancers in men For some men their cancer is monitored Others have surgery to remove the prostate Focal therapy is another treatment option It treats the areas of cancer selectively which leaves the rest of the prostate intact This can help lessen side effects Men who get focal therapy must be chosen carefully The Oncotype DX Genomic Prostate Score GPS assay tests biopsy samples for certain cancer-related genes It then then gives a score from 1 to 100 to predict the likelihood of poor outcomes The GPS is used to choose men for focal therapy Researchers want to test the GPS further
Objective
To assess how GPS may be useful when used with MRI to improve how men are chosen for focal therapy of prostate cancer
Eligibility
Men age 18 and older who had NCCN low or intermediate risk prostate cancer and had MRI and radical prostatectomy at the Urologic Oncology Branch National Cancer Institute and collaborating centers
Design
This is a multisite study It will review data and samples that were collected in the past Samples and images from up to 277 participants will be used
Tumor tissue will be tested with the GPS
Data such as age at diagnosis race biopsy results and pathology results will be merged with the GPS results
Data will be entered into an in-house electronic system It will be password protected All data will be kept in secure sites that comply with NIH security standards
Prostate cancer is one of the most common cancers in men For some men their cancer is monitored Others have surgery to remove the prostate Focal therapy is another treatment option It treats the areas of cancer selectively which leaves the rest of the prostate intact This can help lessen side effects Men who get focal therapy must be chosen carefully The Oncotype DX Genomic Prostate Score GPS assay tests biopsy samples for certain cancer-related genes It then then gives a score from 1 to 100 to predict the likelihood of poor outcomes The GPS is used to choose men for focal therapy Researchers want to test the GPS further
Objective
To assess how GPS may be useful when used with MRI to improve how men are chosen for focal therapy of prostate cancer
Eligibility
Men age 18 and older who had NCCN low or intermediate risk prostate cancer and had MRI and radical prostatectomy at the Urologic Oncology Branch National Cancer Institute and collaborating centers
Design
This is a multisite study It will review data and samples that were collected in the past Samples and images from up to 277 participants will be used
Tumor tissue will be tested with the GPS
Data such as age at diagnosis race biopsy results and pathology results will be merged with the GPS results
Data will be entered into an in-house electronic system It will be password protected All data will be kept in secure sites that comply with NIH security standards
Detailed Description:
Background
Prostate cancer is one of the most common malignancies occurring in men While many men will qualify for active surveillance AS those with intermediate risk disease are often recommended definitive therapy despite the morbidity
Focal therapy for prostate cancer has been promoted as an alternative to the standard paradigm of immediate radical prostatectomy RP versus AS for prostate cancer management Focal therapy treats the areas of cancer selectively leaving the remainder of the prostate intact
While focal therapy offers great promise in terms of minimizing side effects and helping prostate cancer patients avoid radical therapies careful patient selection is required
The Oncotype DX Genomic Prostate Score GPS assay was developed using the ability to extract and amplify RNA of sufficient quantity and quality from the very small amounts of prostate tumor tissue from biopsy samples Using these samples a discovery study identified 12 cancerrelated genes associated with multiple clinically relevant endpoints including adverse pathology biochemical recurrence clinical recurrence and prostate cancer associated death
The GPS assay uses these 12 genes and 5 reference genes to construct an algorithm giving a score from 0-100 to predict the likelihood of adverse pathology
The goal of this study is to evaluate how GPS may be useful in conjunction with MRI to improve patient selection for focal therapy of prostate cancer
Objectives
-To determine if there is a positive association between continuous GPS score and occult high risk andor non-organ confined disease on whole mount prostatectomy specimens where an MRI was performed less than 6 months before diagnostic biopsy and the biopsy was less than 6 months before RP and the lesion was not identified on multiparameter MRI mpMRI
Eligibility
Samples and images from men over 18 years old who were diagnosed with NCCN low or intermediate risk prostate cancer and were managed with radical prostatectomy at the Urologic Oncology Branch National Cancer Institute and collaborating centers
Biopsy Gleason Score 7
Multiparametric MRI with images available for review within 6 months prior to the prostatectomy
Availability of adequate diagnostic biopsy tissue specimen for GPS analysis
Design
This multisite study will be a prospective analysis of retrospective data
Samples and images will be obtained from will consist of approximately 277 evaluable patients who were diagnosed with NCCN low or intermediate risk prostate cancer and were managed with RP at the Urologic Oncology Branch National Cancer Institute and collaborating centers
In the interest of a demographically diverse cohort samples and images from patients from UAB will be identified working in reverse chronological order until the cohort is complete or eligible specimens are exhausted remaining cases will then be selected from the NCI patient population also working in reverse chronological order
Tumor tissue from the highest-grade lesion will be tested with the Oncotype DX Genomic Prostate Scor for generation of the GPS
Clinical characteristics including but not limited to age at diagnosis race PSA biopsy results Prostate MRI PIRADS score and surgical pathology results will be collected and merged with GPS results
Prostate cancer is one of the most common malignancies occurring in men While many men will qualify for active surveillance AS those with intermediate risk disease are often recommended definitive therapy despite the morbidity
Focal therapy for prostate cancer has been promoted as an alternative to the standard paradigm of immediate radical prostatectomy RP versus AS for prostate cancer management Focal therapy treats the areas of cancer selectively leaving the remainder of the prostate intact
While focal therapy offers great promise in terms of minimizing side effects and helping prostate cancer patients avoid radical therapies careful patient selection is required
The Oncotype DX Genomic Prostate Score GPS assay was developed using the ability to extract and amplify RNA of sufficient quantity and quality from the very small amounts of prostate tumor tissue from biopsy samples Using these samples a discovery study identified 12 cancerrelated genes associated with multiple clinically relevant endpoints including adverse pathology biochemical recurrence clinical recurrence and prostate cancer associated death
The GPS assay uses these 12 genes and 5 reference genes to construct an algorithm giving a score from 0-100 to predict the likelihood of adverse pathology
The goal of this study is to evaluate how GPS may be useful in conjunction with MRI to improve patient selection for focal therapy of prostate cancer
Objectives
-To determine if there is a positive association between continuous GPS score and occult high risk andor non-organ confined disease on whole mount prostatectomy specimens where an MRI was performed less than 6 months before diagnostic biopsy and the biopsy was less than 6 months before RP and the lesion was not identified on multiparameter MRI mpMRI
Eligibility
Samples and images from men over 18 years old who were diagnosed with NCCN low or intermediate risk prostate cancer and were managed with radical prostatectomy at the Urologic Oncology Branch National Cancer Institute and collaborating centers
Biopsy Gleason Score 7
Multiparametric MRI with images available for review within 6 months prior to the prostatectomy
Availability of adequate diagnostic biopsy tissue specimen for GPS analysis
Design
This multisite study will be a prospective analysis of retrospective data
Samples and images will be obtained from will consist of approximately 277 evaluable patients who were diagnosed with NCCN low or intermediate risk prostate cancer and were managed with RP at the Urologic Oncology Branch National Cancer Institute and collaborating centers
In the interest of a demographically diverse cohort samples and images from patients from UAB will be identified working in reverse chronological order until the cohort is complete or eligible specimens are exhausted remaining cases will then be selected from the NCI patient population also working in reverse chronological order
Tumor tissue from the highest-grade lesion will be tested with the Oncotype DX Genomic Prostate Scor for generation of the GPS
Clinical characteristics including but not limited to age at diagnosis race PSA biopsy results Prostate MRI PIRADS score and surgical pathology results will be collected and merged with GPS results
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 |
|---|---|---|---|
| 20-C-N136 | None | None | None |