Prostate Cancer Clinical Trial
— PROMM-ASOfficial 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.
Status | Recruiting |
Enrollment | 90 |
Est. completion date | September 30, 2021 |
Est. primary completion date | September 30, 2020 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Patients with a Gleason score of 3+3=6 or 3+4=7a and = 33% of positive biopsy cores verified by an at least 12 core systematic prostate biopsy (SB) - Organ-confined disease (=cT2a), note: tumor-positive biopsies in both lobes with non-palpable tumor are rated as cT1c - PSA value =10 ng/ml Exclusion Criteria: - Gleason score =4+3=7b or a Gleason score 3+4=7a with positive biopsy cores >33% of all cores in SB - PSA >10 ng/ml - Patients not able to give informed consent - Contraindication to mp-MRI - Contraindication to prostate biopsy |
Country | Name | City | State |
---|---|---|---|
Germany | University Düsseldorf, Medical Faculty | Dusseldorf | NRW |
Lead Sponsor | Collaborator |
---|---|
Heinrich-Heine University, Duesseldorf |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction of the discontinuation of Active Surveillance (AS) | Reduction of the discontinuation of AS from 25% to 15% of patients after 24 months based on re-biopsy Gleason score upgrading | 24 months | |
Secondary | Value of MRI (ADC) regarding aggressiveness | Evaluation of ADC values in s/mm2 | 36 months | |
Secondary | Detectionrates of targeted (FUS-GB) versus systematic (TRUS-GB) biopsies | Comparison of detection rates (in %) | 36 months | |
Secondary | Detectionrates of targeted (FUS-GB) versus systematic (TRUS-GB) biopsies | Comparison of Gleason score upgrades (in %) (Gleason score in units 6-10 ) | 36 months | |
Secondary | Correlation of clinical parameters with Gleason score progression or MRI quantified progression | Correlation of PSA elevation in ng/ml | 36 months | |
Secondary | Correlation of clinical parameters with Gleason score progression or MRI quantified progression | Correlation of PSA density in ng/ml/ml | 36 months | |
Secondary | Correlation of clinical parameters with Gleason score progression or MRI quantified progression | Correlation of age in years | 36 months | |
Secondary | Patient compliance to recommended MRI-based observation | Number of patients drop outs | 36 months | |
Secondary | Patient compliance to recommended MRI-based observation | Patient discontinuation rate (in %) | 36 months | |
Secondary | Evaluation of Resolve DWI | Improvement of SNR (signal-to-noise ratio) | 36 months | |
Secondary | Evaluation of Resolve DWI | Subjective Image Quality (5-point scale; evaluated by 2 blinded radiologists; total score from 1=non diagnostic, 2=poor, 3=acceptable, 4=good, to 5=excellent) | 36 months | |
Secondary | Evaluation of Resolve DWI | Improvement of tumor detection rate (in %) | 36 months | |
Secondary | Evaluation of Resolve DWI | NPV (in %) | 36 months |
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