Prostate Cancer Clinical Trial
Official title:
Prospective Phase II Trial Evaluating Multiparametric MRI, Radiomics, MR-guided Biopsy, and Molecular Markers for Active Surveillance of Patients With Low- and Intermediate-Risk Prostate Cancer
Active Surveillance (AS) is a treatment option in patients with favorable risk prostate
cancer. According to the current guidelines patients are monitored by prostate specific
antigen (PSA) testing (every 3 months) and regular re-biopsies. Due to histological
reclassification and/or patient noncompliance a high number of patients discontinue AS.
Nonetheless, because of an increasing number of diagnosed early stage tumors overdiagnosis
and overtreatment of patients has become a major clinical problem. Therefore AS is a
promising and important tool for patients with low and intermediate risk prostate cancer.
Multiparametric MRI (mp-MRI) in combination with radiomics analysis, MR-guided biopsies, and
molecular markers are promising tools to optimize patient selection and observation during
AS.
This prospective, single arm, multicenter phase II study evaluates mp-MRI, radiomics,
MR-guided biopsies and molecular markers for AS with the primary endpoint of reducing
discontinuation based on histologic reclassification.
At the end of this study the results may allow defining a MRI-based pathway to identify and
monitor patients suitable for AS supported by radiomics. Thus, the high rate of
discontinuation due to misclassification at initial diagnosis will be reduced.
Additionally, this strategy will allow reducing over-treatment of clinically insignificant
PCA, and on the other hand, increasing early treatment of higher-risk disease. Monitoring by
mp-MRI will reduce the number of prostate biopsies and cores per patient during AS, and thus
increase the patient compliance. Finally, such a strategy will reduce the economic burden of
treating insignificant prostate cancer.
This prospective multicenter phase II study evaluates multiparametric MRI (mp-MRI), radiomics
and MR-guided biopsies for Active Surveillance (AS) of men with low- and intermediate-risk
prostate cancer (PCA) with the primary endpoint of reducing the rate of discontinuation of AS
based on histologic reclassification in an observation period of 24 months.
Men with low- or intermediate-risk PCA diagnosed by mp-MRI followed by an MR/ultrasound
fusion-guided biopsy (FUS-GB) plus systematic ultrasound-guided biopsy (SB) will be included
in this study.
During the study observation period PSA values will be obtained every 3 months. After having
obtained three values PSA doubling times (PSA-DT) will be calculated at every visit. In case
of PSA-DT <3 years patients will get a repeat mp-MRI and in case of MRI progression a repeat
targeted FUS-GB plus SB will be performed. In case of a Gleason score upgrading by the
targeted biopsy the patient will discontinue AS and get treatment. In cases of stable MRI or
stable Gleason score the patient will continue with PSA controls every 3 months.
In addition all patients with stable PSA values will undergo a mp-MRI after 12 months. If
this MRI demonstrates progression the protocol proceeds as mentioned above for patients with
PSA-increase. At the end of study (24 months after enrollment), all patients will receive
another mp-MRI and FUS-GB+SB.
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