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JOURNAL ONKOLOGIE – STUDIE
PROMM-AS

Prospective Evaluation of Mp-MRI, MR-guided Biopsy, and Molecular Markers for Active Surveillance of Prostate Cancer

Rekrutierend

NCT-Nummer:
NCT03979573

Studienbeginn:
Oktober 2017

Letztes Update:
07.06.2019

Wirkstoff:
-

Indikation (Clinical Trials):
Prostatic Neoplasms

Geschlecht:
Männer

Altersgruppe:
Alle

Phase:
-

Sponsor:
Heinrich-Heine University, Duesseldorf, Heinrich-Heine University, Duesseldorf

Collaborator:
-

Studienleiter

Lars Schimmöller, MD
Principal Investigator
University Düsseldorf, Medical Faculty; Department of Diagnostic and Interventional Radiology
Christian Arsov, MD
Principal Investigator
University Düsseldorf, Medical Faculty; Department of Urology

Kontakt

Lars Schimmöller, MD
Kontakt:
Phone: +49 211-81-08505
E-Mail: Lars.Schimmoeller@med.uni-duesseldorf.de
» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

University Düsseldorf, Medical Faculty
40225 Dusseldorf
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Almut Diem
Phone: +49 211-8119353
E-Mail: diem@med.uni-duesseldorf.de
» Ansprechpartner anzeigen

Studien-Informationen

Detailed Description:

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.
 

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Reduction of the discontinuation of Active Surveillance (AS) (Time Frame - 24 months):
Reduction of the discontinuation of AS from 25% to 15% of patients after 24 months based on re-biopsy Gleason score upgrading



Secondary outcome:

1. Value of MRI (ADC) regarding aggressiveness (Time Frame - 36 months):
Evaluation of ADC values in s/mm2

2. Detectionrates of targeted (FUS-GB) versus systematic (TRUS-GB) biopsies (Time Frame - 36 months):
Comparison of detection rates (in %)

3. Detectionrates of targeted (FUS-GB) versus systematic (TRUS-GB) biopsies (Time Frame - 36 months):
Comparison of Gleason score upgrades (in %) (Gleason score in units 6-10 )

4. Correlation of clinical parameters with Gleason score progression or MRI quantified progression (Time Frame - 36 months):
Correlation of PSA elevation in ng/ml

5. Correlation of clinical parameters with Gleason score progression or MRI quantified progression (Time Frame - 36 months):
Correlation of PSA density in ng/ml/ml

6. Correlation of clinical parameters with Gleason score progression or MRI quantified progression (Time Frame - 36 months):
Correlation of age in years

7. Patient compliance to recommended MRI-based observation (Time Frame - 36 months):
Number of patients drop outs

8. Patient compliance to recommended MRI-based observation (Time Frame - 36 months):
Patient discontinuation rate (in %)

9. Evaluation of Resolve DWI (Time Frame - 36 months):
Improvement of SNR (signal-to-noise ratio)

10. Evaluation of Resolve DWI (Time Frame - 36 months):
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)

11. Evaluation of Resolve DWI (Time Frame - 36 months):
Improvement of tumor detection rate (in %)

12. Evaluation of Resolve DWI (Time Frame - 36 months):
NPV (in %)

Geprüfte Regime

  • Multiparametric MRI:
    Multiparametric prostate MRI (mp-MRI)
  • Radiomics:
    Radiomics analyses will consist of image intensity normalization, image coregistration and resampling, radiomic feature extraction, combination with clinical and molecular parameters, feature extraction and machine learning, model testing on validation and test cohorts and comparison to existing clinical risk models.
  • MR-guided Biopsy:
    MR-guided targeted prostate biopsies as well as systematic TRUS-guided biopsies (at least 12 cores) will be performed on a fusion-guided biopsy system. The biopsy cores can either be obtained transrectal or transperineal.
  • Molecular Markers:
    Molecular markers will be analyzed on the initial and final targeted and systematic biopsy cores. The molecular panel consists of a methylation-specific PCR and a set of highly selected markers that can be detected by immunohistochemistry. The resulting data will be prospectively recorded to enable a retrospective analysis of the prognostic value.

Quelle: ClinicalTrials.gov


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