Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04541030 |
| Other study ID # |
999920136 |
| Secondary ID |
20-C-N136 |
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 2, 2020 |
| Est. completion date |
March 1, 2025 |
Study information
| Verified date |
July 31, 2023 |
| Source |
National Institutes of Health Clinical Center (CC) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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 and/or 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.
