NCT03979573

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable prostate-cancer

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2018

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

June 7, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

June 7, 2019

Status Verified

June 1, 2019

Enrollment Period

3 years

First QC Date

January 28, 2018

Last Update Submit

June 6, 2019

Conditions

Prostate Cancer

Keywords

Prospective StudyMultiparametric MRIRadiomicsMR-guided BiopsyMolecular MarkersActive SurveillanceProstate Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • Value of MRI (ADC) regarding aggressiveness

    36 months

  • Detectionrates of targeted (FUS-GB) versus systematic (TRUS-GB) biopsies

    36 months

  • Detectionrates of targeted (FUS-GB) versus systematic (TRUS-GB) biopsies

    36 months

  • Correlation of clinical parameters with Gleason score progression or MRI quantified progression

    36 months

  • Correlation of clinical parameters with Gleason score progression or MRI quantified progression

    36 months

  • +7 more secondary outcomes

Study Arms (1)

Intervention Arm

OTHER

* PSA testing * Multiparametric MRI (mp-MRI) * Radiomics * MR-guided biopsy (MR-guided and systematic US-guided) * Molecular Markers (Histological analysis of biopsy cores)

Diagnostic Test: Multiparametric MRIDiagnostic Test: RadiomicsDiagnostic Test: MR-guided BiopsyDiagnostic Test: Molecular Markers

Interventions

Multiparametric MRIDIAGNOSTIC_TEST

Multiparametric prostate MRI (mp-MRI)

Intervention Arm
RadiomicsDIAGNOSTIC_TEST

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.

Intervention Arm
MR-guided BiopsyDIAGNOSTIC_TEST

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.

Intervention Arm
Molecular MarkersDIAGNOSTIC_TEST

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.

Intervention Arm

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Düsseldorf, Medical Faculty

Düsseldorf, North Rhine-Westphalia, 40225, Germany

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Multiparametric Magnetic Resonance ImagingRadiomics

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Magnetic Resonance ImagingTomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Lars Schimmöller, MD

    University Düsseldorf, Medical Faculty; Department of Diagnostic and Interventional Radiology

    PRINCIPAL INVESTIGATOR

  • Christian Arsov, MD

    University Düsseldorf, Medical Faculty; Department of Urology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lars Schimmöller, MD

CONTACT

+49 211-81-08505Lars.Schimmoeller@med.uni-duesseldorf.de

Christian Arsov, MD

CONTACT

+49 211-81-08607Christian.Arsov@med.uni-duesseldorf.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Prospective' Single-Arm, Phase-II Study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2018

First Posted

June 7, 2019

Study Start

October 1, 2017

Primary Completion

September 30, 2020

Study Completion

September 30, 2021

Last Updated

June 7, 2019

Record last verified: 2019-06

Locations

DE(1)