Prostate CancerPROMM-ASNCT03979573
Prospective Evaluation of Mp-MRI, MR-guided Biopsy, and Molecular Markers for Active Surveillance of Prostate Cancer
A study testing Multiparametric MRI, Radiomics and MR-guided Biopsy in people with Prostate Cancer, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Multiparametric MRI, Radiomics and MR-guided Biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2017to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Düsseldorf, Medical Faculty
Düsseldorf, North Rhine-Westphalia, 40225
Almut Diem, +49 211-8119353, diem@med.uni-duesseldorf.de
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Multiparametric MRI, Radiomics, MR-guided Biopsy, Molecular Markers
- Keywords
- Prospective Study, Multiparametric MRI, Radiomics, MR-guided Biopsy, Molecular Markers, Active Surveillance, Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiparametric MRIDiagnostic test
Multiparametric prostate MRI (mp-MRI)
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.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Diagnostic Test: Multiparametric MRI; Diagnostic Test: Radiomics; Diagnostic Test: MR-guided Biopsy; Diagnostic Test: Molecular Markers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months
Secondary outcomes (12)
Value of MRI (ADC) regarding aggressiveness
Evaluation of ADC values in s/mm2
Measured: 36 months
Detectionrates of targeted (FUS-GB) versus systematic (TRUS-GB) biopsies
Comparison of detection rates (in %)
Measured: 36 months
Detectionrates of targeted (FUS-GB) versus systematic (TRUS-GB) biopsies
Comparison of Gleason score upgrades (in %) (Gleason score in units 6-10 )
Measured: 36 months
Correlation of clinical parameters with Gleason score progression or MRI quantified progression
Correlation of PSA elevation in ng/ml
Measured: 36 months
Correlation of clinical parameters with Gleason score progression or MRI quantified progression
Correlation of PSA density in ng/ml/ml
Measured: 36 months
Correlation of clinical parameters with Gleason score progression or MRI quantified progression
Correlation of age in years
Measured: 36 months
Patient compliance to recommended MRI-based observation
Number of patients drop outs
Measured: 36 months
Patient compliance to recommended MRI-based observation
Patient discontinuation rate (in %)
Measured: 36 months
Evaluation of Resolve DWI
Improvement of SNR (signal-to-noise ratio)
Measured: 36 months
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)
Measured: 36 months
Evaluation of Resolve DWI
Improvement of tumor detection rate (in %)
Measured: 36 months
Evaluation of Resolve DWI
NPV (in %)
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start1 Oct 2017
- Primary completion30 Sep 2020 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective' Single-Arm, Phase-II Study
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lars Schimmöller, MD, Principal investigator, University Düsseldorf, Medical Faculty; Department of Diagnostic and Interventional RadiologyChristian Arsov, MD, Principal investigator, University Düsseldorf, Medical Faculty; Department of Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03979573
- Sponsor's protocol ID
- 5941R
- Acronym
- PROMM-AS
- Status last verified
- Jun 2019
- First submitted
- 28 Jan 2018
- Last updated
- 7 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03979573
- Acronym / sponsor ID
- PROMM-AS / 5941R
- Conditions
- Prostate Cancer
- Keywords
- Prospective Study, Multiparametric MRI, Radiomics, MR-guided Biopsy, Molecular Markers, Active Surveillance, Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 7 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective' Single-Arm, Phase-II Study
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Other | Diagnostic Test: Multiparametric MRI, Diagnostic Test: Radiomics, Diagnostic Test: MR-guided Biopsy, Diagnostic Test: Molecular Markers* PSA testing * Multiparametric MRI (mp-MRI) * Radiomics * MR-guided biopsy (MR-guided and systematic US-guided) * Molecular Markers (Histological analysis of biopsy cores) |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiparametric MRIMultiparametric prostate MRI (mp-MRI) | Diagnostic test | Intervention Arm |
| RadiomicsRadiomics 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. | Diagnostic test | Intervention Arm |
| MR-guided BiopsyMR-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. | Diagnostic test | Intervention Arm |
| Molecular MarkersMolecular 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. | Diagnostic test | Intervention Arm |
Primary outcome
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
12 secondary outcomes
Value of MRI (ADC) regarding aggressiveness
Time frame: 36 months
Detectionrates of targeted (FUS-GB) versus systematic (TRUS-GB) biopsies
Time frame: 36 months
Detectionrates of targeted (FUS-GB) versus systematic (TRUS-GB) biopsies
Time frame: 36 months
Correlation of clinical parameters with Gleason score progression or MRI quantified progression
Time frame: 36 months
Correlation of clinical parameters with Gleason score progression or MRI quantified progression
Time frame: 36 months
Correlation of clinical parameters with Gleason score progression or MRI quantified progression
Time frame: 36 months
Patient compliance to recommended MRI-based observation
Time frame: 36 months
Patient compliance to recommended MRI-based observation
Time frame: 36 months
Evaluation of Resolve DWI
Time frame: 36 months
Evaluation of Resolve DWI
Time frame: 36 months
Evaluation of Resolve DWI
Time frame: 36 months
Evaluation of Resolve DWI
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multiparametric MRI, Radiomics and MR-guided Biopsy in people with Prostate Cancer, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lars Schimmöller, MD (+49 211-81-08505, Lars.Schimmoeller@med.uni-duesseldorf.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of the discontinuation of Active Surveillance (AS) (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2019.