Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04983459 |
| Other study ID # |
RB-PSMA (29BRC21.0040) |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2018 |
| Est. completion date |
December 31, 2020 |
Study information
| Verified date |
July 2021 |
| Source |
University Hospital, Brest |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The aim of this study is to evaluate PSMA-PET for the detection of occult biological
recurrence in patients with prostatic cancer referred to the Brest University Hospital.
Description:
In France, prostate cancer is the most common cancer in men over 50 years of age (nearly
50,000 new cases per year) and is the third leading cause of cancer-related death in men
(approximately 9,000 deaths per year).
Among patients who have undergone a curative treatment strategy for localized prostate
cancer, between 27% and 53% of them will have a biochemical recurrence within 10 years.
Biochemical recurrence is defined as :
- After total prostatectomy by the persistence of a detectable PSA or the reappearance of
a detectable PSA above 0.2 ng/ml after a more or less long period of undetectability.
- After conservative treatment (radiotherapy or brachytherapy) by an increase in PSA above
a threshold set at nadir +2 ng/ml Biological recurrence precedes the occurrence of
symptomatic metastases by an average of 7-8 years.
Currently, after prostatectomy, when the PSA is < 1 ng/mL, no imaging test is recommended for
the assessment of recurrence (grade A recommendation).
The sensitivity of currently available tests does not provide sufficiently discriminating
information for this PSA value.
Multiparametric MRI performs well in detecting local recurrence, particularly in the case of
PSA > 1 ng/mL (sensitivity of 98%, specificity of 94% for the detection of 5 mm lesions).
18F-choline positron emission tomography (PET-choline) is of interest in the detection of
distant lymph node and/or visceral recurrences; indeed, PET-choline has proven its
superiority in detection compared with conventional examinations, particularly for PSA values
above 2ng/ml with a detection rate of up to 90%.
However, the performance of this examination remains dependent on the PSA level and is low
when the PSA level is below 1 ng/ml (sensitivity around 5-24% for a PSA below 1 ng/ml).
The performance of PET-choline is optimised for low PSA by taking into account the PSA
doubling time and velocity.
Recently, prostate specific membrane antigen ligand positron emission tomography (PET-PSMA)
has emerged as the most promising new molecular imaging modality for the management of
prostate cancer.
Prostate-specific membrane antigen (PSMA) is a transmembrane glycoprotein selectively
overexpressed in 90-100% of prostate cancer lesions, as well as in metastatic lymph nodes and
bone metastases, making it an ideal target for molecular imaging of prostate cancer.
This tracer appears to perform better than other imaging modalities, particularly for low PSA
values, with a detection rate of 50% for a PSA level below 0.5 ng/ml compared to 5-20% with
PET-choline. Indeed, a 2019 meta-analysis evaluating the value of PSMA-PET in patients with
biologic recurrence of prostate adenocarcinoma reported detection rates of 45%, 59%, 75% and
95% for PSA levels < 0.5 ng/mL, between 0.5 and 0.9 ng/mL, between 1 and 1.9 ng/mL and 2
ng/mL respectively.
The aim of this study is to evaluate PSMA ligand PET for the detection of occult biological
recurrence in patients with prostatic neoplasia referred to the Brest University Hospital .
