Prostate CancerNCT03615131
Accuracy of mpMRI and MRI-targeted, Ultrasound-navigated Prostate Fusion Biopsy in Detection of Prostate Cancer
An observational study of Prostate Cancer, run by Kantonsspital Winterthur KSW at 1 site in Switzerland.
Trial summary
The investigators examined whether a high PI-RADS v2 score correlates with the presence of prostate cancer. In addition, the investigator inspected whether the lesion size as determined by mpMRI correlates with the presence of prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- MRI-TRUS fusion prostate biopsy
- How many people
- 157 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2015to 30 Mar 2017
- Phase
- Observational
- 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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Men with a suspicious prostate cancer screening for the early detection of prostate cancer (PSA> 4 ng / ml, PSA velocity> 0.75 ng / ml / y or pathological DRE) or a planned re-biopsy in the context of active surveillance with known very-low-risk prostate cancer.
Who may be able to join
- Patients with mRI-TRUS Fusion prostate biopsy
- age > 18y
- elevated PSA
- suspicious DRE (digital rectal examination)
- patients with prostate cancer under active surveillance
Who cannot join
- age < 18y
- treated prostate cancer (Radiotherapy, antiandrogens therapy, brachytherapy, HIFU).
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Klinik für Urologie Kantonsspital Winterthur
Winterthur, Canton of Zurich, 8401
About this study
Official title: Accuracy of Multi-parametric Prostate MRI and MRI-targeted, Ultrasound-navigated Prostate Fusion Biopsy in the Detection of Prostate Cancer:
The investigators examined whether a high PI-RADS v2 score correlates with the presence of prostate cancer. In addition, the investigator inspected whether the lesion size as determined by mpMRI correlates with the presence of prostate cancer. Furthermore, the investigators study aimed to determine the sensitivity and specificity of mpMRI with respect to prostate carcinoma detection.
Read the detailed description
Purpose: In recent years, multiparametric Magnet Resonance Imaging (mpMRI) has been established as a diagnostic imaging technique of the prostate and its assessment standardized with the "prostate imaging - data and reporting system" (PI-RADS v2). The previously established Likert scale from 1 to 5 has been shown to reflect the increasing probability of a carcinoma. Suspicious MRI lesions can be biopsied in a targeted fashion using ultrasound navigation termed fusion biopsy. The investigators examined whether a high PI-RADS v2 score correlates with the presence of prostate cancer. In addition, the investigators inspected whether the lesion size as determined by mpMRI correlates with the presence of prostate cancer. Furthermore, the investigators study aimed to determine the sensitivity and specificity of mpMRI with respect to prostate carcinoma detection.
Materials and Methods: This prospective study includes 228 consecutive patients, which underwent a perineal MRI-TRUS-fused prostate biopsy (BiopSee®, MedCom Company) during the period of September 2015 to March 2017 at the cantonal hospital Winterthur due to a suspicious PSA value, a suspicious digital rectal examination or a known prostate cancer under active surveillance. 71 patients were excluded due to lack of PI-RADS v2 diagnosis and / or MRI performed at a different center. Targeted biopsies were performed specifically in the indicated MRI lesions and standardized over the rest of the prostate (system biopsy).
- Conditions
- Prostate Cancer
- Being tested
- MRI-TRUS fusion prostate biopsy
- Keywords
- Prostate cancer, mpMRI-TRUS fusion biopsy, PIRADS, Gleason score
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI-TRUS fusion prostate biopsyDiagnostic test
Also called MRI prior to biopsy
First an advanced MRI prostate image is obtained, annotated and recorded by the Radiology of the Kantonsspital Winterthur. Next, using special fusion technology, the recorded MRI image is fused with a live transrectal ultrasound by the Urologist who performs a MRI/TRUS fusion biopsy.
| Study group | Role | What they receive |
|---|---|---|
| MRI-TRUS fusion prostate biopsy | Single Arm Study, MRI and Prostate-Biopsy on same patient, individual patient acts as own control for intervention Receives: Diagnostic Test: MRI-TRUS fusion prostate biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gleason score (minimum 2 to maximum of 10)
Histological grade of the glandular structures of prostate cancer tissue or the difference in appearance compared with a normal structure.
Pattern 1 - corresponds to a well differentiated carcinoma. Pattern 2 - corresponds to a moderately differentiated carcinoma. Pattern 3 - invade the surrounding tissue or having an infiltrative pattern; corresponds to a moderately differentiated carcinoma.
Pattern 4 - corresponds to a poorly differentiated carcinoma. Pattern 5 - corresponds to an anaplastic carcinoma.
The pathologist then sums the pattern-number of the primary and secondary grades to obtain the final Gleason score.
Gleason scores range from 2 to 10, with 2 representing the most well-differentiated tumors and 10 the least-differentiated tumors.
Measured: 01.09.2015 - 30.03.2017
ISUP (International Society of Urological Pathology) Grading Group (Grade 1 to Grade 5)
New grading system for histological grade of the glandular structures of prostate cancer tissue or the difference in appearance compared with a normal structure
Grade Group 1 (Gleason score ≤6) - Only individual discrete well-formed glands Grade Group 2 (Gleason score 3+4=7) - Predominantly well-formed glands with a lesser component of poorly-formed/fused/cribriform glands Grade Group 3 (Gleason score 4+3=7) - Predominantly poorly-formed/fused/cribriform glands with a lesser component of well-formed glands Grade Group 4 (Gleason score 8)
- Only poorly-formed/fused/cribriform glands or
- Predominantly well-formed glands with a lesser component lacking glands or
- Predominantly lacking glands with a lesser component of well-formed glands Grade Group 5 (Gleason scores 9-10) - Lacks gland formation (or with necrosis) with or without poorly-formed/fused/cribriform glands
Measured: 01.09.2015 - 30.03.2017
lesion volume (ml)
millilitre; size of suspected areas in prostate gland in MRI
Measured: 01.09.2015 - 30.03.2017
PI-RADS v2 (Prostate Imaging Reporting and Data System Version 2) score (1 - 5)
Radiological grading system of prostate lesions in mpMRI
The PI-RADS v2 system is designed to standardize image acquisition and reporting, and to be used by medical professionals in the initial evaluation of patients to assess the risk of clinically significant prostate cancer that may require biopsy and treatment.
The scale is based on a score "Yes" or "No" for Dynamic Contrast-Enhanced (DCE) parameter, and from 1 to 5 for T2-weighted (T2W) and Diffusion-weighted imaging (DWI). The score is given for each lesion, with 1 being most probably benign and 5 being highly suspicious of malignancy:
PI-RADS 1: very low (clinically significant cancer is highly unlikely to be present) PI-RADS 2: low (clinically significant cancer is unlikely to be present) PI-RADS 3: intermediate (clinically significant cancer is equivocal) PI-RADS 4: high (clinically significant cancer is likely to be present) PI-RADS 5: very high (clinically significant cancer is highly likely to be present)
Measured: 01.09.2015 - 30.03.2017
Prostate specific antigen (PSA)
ng per ml; enzyme secreted by the prostate gland
Measured: 01.09.2015 - 30.03.2017
Digital rectal examination (DRE)
consistence of prostate gland
Measured: 01.09.2015 - 30.03.2017
Prostate specific antigen - density
ng per ml per ml; The relationship of the prostate specific antigen level to the size and weight (volume) of the prostate.
Measured: 01.09.2015 - 30.03.2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start1 Sep 2015
- Primary completion30 Mar 2017
- Study completion30 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Winterthur KSW
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03615131
- Sponsor's protocol ID
- 2016-01098
- Other IDs
- 2016
- Status last verified
- Aug 2018
- First submitted
- 16 Jul 2018
- Last updated
- 22 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Siegel R, DeSantis C, Virgo K, Stein K, Mariotto A, Smith T, Cooper D, Gansler T, Lerro C, Fedewa S, Lin C, Leach C, Cannady RS, Cho H, Scoppa S, Hachey M, Kirch R, Jemal A, Ward E. Cancer treatment and survivorship statistics, 2012. CA Cancer J Clin. 2012 Jul-Aug;62(4):220-41. doi: 10.3322/caac.21149. Epub 2012 Jun 14.
PubMed 22700443Heidenreich A, Bastian PJ, Bellmunt J, Bolla M, Joniau S, van der Kwast T, Mason M, Matveev V, Wiegel T, Zattoni F, Mottet N; European Association of Urology. EAU guidelines on prostate cancer. part 1: screening, diagnosis, and local treatment with curative intent-update 2013. Eur Urol. 2014 Jan;65(1):124-37. doi: 10.1016/j.eururo.2013.09.046. Epub 2013 Oct 6.
PubMed 24207135Hoeks CM, Barentsz JO, Hambrock T, Yakar D, Somford DM, Heijmink SW, Scheenen TW, Vos PC, Huisman H, van Oort IM, Witjes JA, Heerschap A, Futterer JJ. Prostate cancer: multiparametric MR imaging for detection, localization, and staging. Radiology. 2011 Oct;261(1):46-66. doi: 10.1148/radiol.11091822.
PubMed 21931141Hamoen EHJ, de Rooij M, Witjes JA, Barentsz JO, Rovers MM. Use of the Prostate Imaging Reporting and Data System (PI-RADS) for Prostate Cancer Detection with Multiparametric Magnetic Resonance Imaging: A Diagnostic Meta-analysis. Eur Urol. 2015 Jun;67(6):1112-1121. doi: 10.1016/j.eururo.2014.10.033. Epub 2014 Nov 6.
PubMed 25466942Weinreb JC, Barentsz JO, Choyke PL, Cornud F, Haider MA, Macura KJ, Margolis D, Schnall MD, Shtern F, Tempany CM, Thoeny HC, Verma S. PI-RADS Prostate Imaging - Reporting and Data System: 2015, Version 2. Eur Urol. 2016 Jan;69(1):16-40. doi: 10.1016/j.eururo.2015.08.052. Epub 2015 Oct 1.
PubMed 26427566Barentsz JO, Richenberg J, Clements R, Choyke P, Verma S, Villeirs G, Rouviere O, Logager V, Futterer JJ; European Society of Urogenital Radiology. ESUR prostate MR guidelines 2012. Eur Radiol. 2012 Apr;22(4):746-57. doi: 10.1007/s00330-011-2377-y. Epub 2012 Feb 10.
PubMed 22322308Renard Penna R, Brenot-Rossi I, Salomon L, Soulie M. [Prostate cancer imaging: MRI and nuclear imaging]. Prog Urol. 2015 Nov;25(15):933-46. doi: 10.1016/j.purol.2015.07.016. French.
PubMed 26519961Roethke MC, Kuru TH, Schultze S, Tichy D, Kopp-Schneider A, Fenchel M, Schlemmer HP, Hadaschik BA. Evaluation of the ESUR PI-RADS scoring system for multiparametric MRI of the prostate with targeted MR/TRUS fusion-guided biopsy at 3.0 Tesla. Eur Radiol. 2014 Feb;24(2):344-52. doi: 10.1007/s00330-013-3017-5. Epub 2013 Oct 3.
PubMed 24196383Schimmoller L, Quentin M, Arsov C, Lanzman RS, Hiester A, Rabenalt R, Antoch G, Albers P, Blondin D. Inter-reader agreement of the ESUR score for prostate MRI using in-bore MRI-guided biopsies as the reference standard. Eur Radiol. 2013 Nov;23(11):3185-90. doi: 10.1007/s00330-013-2922-y. Epub 2013 Jun 12.
PubMed 23756958Kuru TH, Herden J, Zugor V, Akbarov I, Pfister D, Porres D, Heidenreich A. How to Perform Image-guided Prostate Biopsy: In-bore and Fusion Approaches. Eur Urol Focus. 2016 Jun;2(2):151-153. doi: 10.1016/j.euf.2016.03.016. Epub 2016 Apr 12.
PubMed 28723529Arsov C, Rabenalt R, Blondin D, Quentin M, Hiester A, Godehardt E, Gabbert HE, Becker N, Antoch G, Albers P, Schimmoller L. Prospective randomized trial comparing magnetic resonance imaging (MRI)-guided in-bore biopsy to MRI-ultrasound fusion and transrectal ultrasound-guided prostate biopsy in patients with prior negative biopsies. Eur Urol. 2015 Oct;68(4):713-20. doi: 10.1016/j.eururo.2015.06.008. Epub 2015 Jun 23.
PubMed 26116294Quentin M, Blondin D, Arsov C, Schimmoller L, Hiester A, Godehardt E, Albers P, Antoch G, Rabenalt R. Prospective evaluation of magnetic resonance imaging guided in-bore prostate biopsy versus systematic transrectal ultrasound guided prostate biopsy in biopsy naive men with elevated prostate specific antigen. J Urol. 2014 Nov;192(5):1374-9. doi: 10.1016/j.juro.2014.05.090. Epub 2014 May 24.
PubMed 24866597Vargas HA, Hotker AM, Goldman DA, Moskowitz CS, Gondo T, Matsumoto K, Ehdaie B, Woo S, Fine SW, Reuter VE, Sala E, Hricak H. Updated prostate imaging reporting and data system (PIRADS v2) recommendations for the detection of clinically significant prostate cancer using multiparametric MRI: critical evaluation using whole-mount pathology as standard of reference. Eur Radiol. 2016 Jun;26(6):1606-12. doi: 10.1007/s00330-015-4015-6. Epub 2015 Sep 22.
PubMed 26396111Samaratunga H, Delahunt B, Yaxley J, Srigley JR, Egevad L. From Gleason to International Society of Urological Pathology (ISUP) grading of prostate cancer. Scand J Urol. 2016 Oct;50(5):325-9. doi: 10.1080/21681805.2016.1201858. Epub 2016 Jul 14.
PubMed 27415753Egevad L, Delahunt B, Srigley JR, Samaratunga H. International Society of Urological Pathology (ISUP) grading of prostate cancer - An ISUP consensus on contemporary grading. APMIS. 2016 Jun;124(6):433-5. doi: 10.1111/apm.12533.
PubMed 27150257
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Multi-parametric Prostate MRI and MRI-targeted, Ultrasound-navigated Prostate Fusion Biopsy in the Detection of Prostate Cancer:
- ClinicalTrials.gov ID
- NCT03615131
- Acronym / sponsor ID
- 2016-01098
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, mpMRI-TRUS fusion biopsy, PIRADS, Gleason score
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Kantonsspital Winterthur KSWUniversity, hospital or other
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 30 Mar 2017 (actual)
- Study completion
- 30 Mar 2017 (actual)
- First posted
- 3 Aug 2018 (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.
The investigators examined whether a high PI-RADS v2 score correlates with the presence of prostate cancer. In addition, the investigator inspected whether the lesion size as determined by mpMRI correlates with the presence of prostate cancer. Furthermore, the investigators study aimed to determine the sensitivity and specificity of mpMRI with respect to prostate carcinoma detection.
Detailed description
Purpose: In recent years, multiparametric Magnet Resonance Imaging (mpMRI) has been established as a diagnostic imaging technique of the prostate and its assessment standardized with the "prostate imaging - data and reporting system" (PI-RADS v2). The previously established Likert scale from 1 to 5 has been shown to reflect the increasing probability of a carcinoma. Suspicious MRI lesions can be biopsied in a targeted fashion using ultrasound navigation termed fusion biopsy. The investigators examined whether a high PI-RADS v2 score correlates with the presence of prostate cancer. In addition, the investigators inspected whether the lesion size as determined by mpMRI correlates with the presence of prostate cancer. Furthermore, the investigators study aimed to determine the sensitivity and specificity of mpMRI with respect to prostate carcinoma detection.
Materials and Methods: This prospective study includes 228 consecutive patients, which underwent a perineal MRI-TRUS-fused prostate biopsy (BiopSee®, MedCom Company) during the period of September 2015 to March 2017 at the cantonal hospital Winterthur due to a suspicious PSA value, a suspicious digital rectal examination or a known prostate cancer under active surveillance. 71 patients were excluded due to lack of PI-RADS v2 diagnosis and / or MRI performed at a different center. Targeted biopsies were performed specifically in the indicated MRI lesions and standardized over the rest of the prostate (system biopsy).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI-TRUS fusion prostate biopsy | – | Diagnostic Test: MRI-TRUS fusion prostate biopsySingle Arm Study, MRI and Prostate-Biopsy on same patient, individual patient acts as own control for intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Men with a suspicious prostate cancer screening for the early detection of prostate cancer (PSA> 4 ng / ml, PSA velocity> 0.75 ng / ml / y or pathological DRE) or a planned re-biopsy in the context of active surveillance with known very-low-risk prostate cancer.
Key inclusion criteria (5 listed)
- Patients with mRI-TRUS Fusion prostate biopsy
- age > 18y
- elevated PSA
- suspicious DRE (digital rectal examination)
- patients with prostate cancer under active surveillance
Key exclusion criteria (2 listed)
- age < 18y
- treated prostate cancer (Radiotherapy, antiandrogens therapy, brachytherapy, HIFU).
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 |
|---|---|---|
| MRI-TRUS fusion prostate biopsyAlso: MRI prior to biopsyFirst an advanced MRI prostate image is obtained, annotated and recorded by the Radiology of the Kantonsspital Winterthur. Next, using special fusion technology, the recorded MRI image is fused with a live transrectal ultrasound by the Urologist who performs a MRI/TRUS fusion biopsy. | Diagnostic test | MRI-TRUS fusion prostate biopsy |
Primary outcome
Gleason score (minimum 2 to maximum of 10)
Time frame: 01.09.2015 - 30.03.2017
Histological grade of the glandular structures of prostate cancer tissue or the difference in appearance compared with a normal structure. Pattern 1 - corresponds to a well differentiated carcinoma. Pattern 2 - corresponds to a moderately differentiated carcinoma. Pattern 3 - invade the surrounding tissue or having an infiltrative pattern; corresponds to a moderately differentiated carcinoma. Pattern 4 - corresponds to a poorly differentiated carcinoma. Pattern 5 - corresponds to an anaplastic carcinoma. The pathologist then sums the pattern-number of the primary and secondary grades to obtain the final Gleason score. Gleason scores range from 2 to 10, with 2 representing the most well-differentiated tumors and 10 the least-differentiated tumors.
ISUP (International Society of Urological Pathology) Grading Group (Grade 1 to Grade 5)
Time frame: 01.09.2015 - 30.03.2017
New grading system for histological grade of the glandular structures of prostate cancer tissue or the difference in appearance compared with a normal structure Grade Group 1 (Gleason score ≤6) - Only individual discrete well-formed glands Grade Group 2 (Gleason score 3+4=7) - Predominantly well-formed glands with a lesser component of poorly-formed/fused/cribriform glands Grade Group 3 (Gleason score 4+3=7) - Predominantly poorly-formed/fused/cribriform glands with a lesser component of well-formed glands Grade Group 4 (Gleason score 8) * Only poorly-formed/fused/cribriform glands or * Predominantly well-formed glands with a lesser component lacking glands or * Predominantly lacking glands with a lesser component of well-formed glands Grade Group 5 (Gleason scores 9-10) - Lacks gland formation (or with necrosis) with or without poorly-formed/fused/cribriform glands
lesion volume (ml)
Time frame: 01.09.2015 - 30.03.2017
millilitre; size of suspected areas in prostate gland in MRI
PI-RADS v2 (Prostate Imaging Reporting and Data System Version 2) score (1 - 5)
Time frame: 01.09.2015 - 30.03.2017
Radiological grading system of prostate lesions in mpMRI The PI-RADS v2 system is designed to standardize image acquisition and reporting, and to be used by medical professionals in the initial evaluation of patients to assess the risk of clinically significant prostate cancer that may require biopsy and treatment. The scale is based on a score "Yes" or "No" for Dynamic Contrast-Enhanced (DCE) parameter, and from 1 to 5 for T2-weighted (T2W) and Diffusion-weighted imaging (DWI). The score is given for each lesion, with 1 being most probably benign and 5 being highly suspicious of malignancy: PI-RADS 1: very low (clinically significant cancer is highly unlikely to be present) PI-RADS 2: low (clinically significant cancer is unlikely to be present) PI-RADS 3: intermediate (clinically significant cancer is equivocal) PI-RADS 4: high (clinically significant cancer is likely to be present) PI-RADS 5: very high (clinically significant cancer is highly likely to be present)
Prostate specific antigen (PSA)
Time frame: 01.09.2015 - 30.03.2017
ng per ml; enzyme secreted by the prostate gland
Digital rectal examination (DRE)
Time frame: 01.09.2015 - 30.03.2017
consistence of prostate gland
Prostate specific antigen - density
Time frame: 01.09.2015 - 30.03.2017
ng per ml per ml; The relationship of the prostate specific antigen level to the size and weight (volume) of the prostate.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
- Background: PubMed 22700443Siegel R, DeSantis C, Virgo K, Stein K, Mariotto A, Smith T, Cooper D, Gansler T, Lerro C, Fedewa S, Lin C, Leach C, Cannady RS, Cho H, Scoppa S, Hachey M, Kirch R, Jemal A, Ward E. Cancer treatment and survivorship statistics, 2012. CA Cancer J Clin. 2012 Jul-Aug;62(4):220-41. doi: 10.3322/caac.21149. Epub 2012 Jun 14.
- Background: PubMed 24207135Heidenreich A, Bastian PJ, Bellmunt J, Bolla M, Joniau S, van der Kwast T, Mason M, Matveev V, Wiegel T, Zattoni F, Mottet N; European Association of Urology. EAU guidelines on prostate cancer. part 1: screening, diagnosis, and local treatment with curative intent-update 2013. Eur Urol. 2014 Jan;65(1):124-37. doi: 10.1016/j.eururo.2013.09.046. Epub 2013 Oct 6.
- Background: PubMed 21931141Hoeks CM, Barentsz JO, Hambrock T, Yakar D, Somford DM, Heijmink SW, Scheenen TW, Vos PC, Huisman H, van Oort IM, Witjes JA, Heerschap A, Futterer JJ. Prostate cancer: multiparametric MR imaging for detection, localization, and staging. Radiology. 2011 Oct;261(1):46-66. doi: 10.1148/radiol.11091822.
- Background: PubMed 25466942Hamoen EHJ, de Rooij M, Witjes JA, Barentsz JO, Rovers MM. Use of the Prostate Imaging Reporting and Data System (PI-RADS) for Prostate Cancer Detection with Multiparametric Magnetic Resonance Imaging: A Diagnostic Meta-analysis. Eur Urol. 2015 Jun;67(6):1112-1121. doi: 10.1016/j.eururo.2014.10.033. Epub 2014 Nov 6.
- Background: PubMed 26427566Weinreb JC, Barentsz JO, Choyke PL, Cornud F, Haider MA, Macura KJ, Margolis D, Schnall MD, Shtern F, Tempany CM, Thoeny HC, Verma S. PI-RADS Prostate Imaging - Reporting and Data System: 2015, Version 2. Eur Urol. 2016 Jan;69(1):16-40. doi: 10.1016/j.eururo.2015.08.052. Epub 2015 Oct 1.
- Background: PubMed 22322308Barentsz JO, Richenberg J, Clements R, Choyke P, Verma S, Villeirs G, Rouviere O, Logager V, Futterer JJ; European Society of Urogenital Radiology. ESUR prostate MR guidelines 2012. Eur Radiol. 2012 Apr;22(4):746-57. doi: 10.1007/s00330-011-2377-y. Epub 2012 Feb 10.
- Background: PubMed 26519961Renard Penna R, Brenot-Rossi I, Salomon L, Soulie M. [Prostate cancer imaging: MRI and nuclear imaging]. Prog Urol. 2015 Nov;25(15):933-46. doi: 10.1016/j.purol.2015.07.016. French.
- Background: PubMed 24196383Roethke MC, Kuru TH, Schultze S, Tichy D, Kopp-Schneider A, Fenchel M, Schlemmer HP, Hadaschik BA. Evaluation of the ESUR PI-RADS scoring system for multiparametric MRI of the prostate with targeted MR/TRUS fusion-guided biopsy at 3.0 Tesla. Eur Radiol. 2014 Feb;24(2):344-52. doi: 10.1007/s00330-013-3017-5. Epub 2013 Oct 3.
- Background: PubMed 23756958Schimmoller L, Quentin M, Arsov C, Lanzman RS, Hiester A, Rabenalt R, Antoch G, Albers P, Blondin D. Inter-reader agreement of the ESUR score for prostate MRI using in-bore MRI-guided biopsies as the reference standard. Eur Radiol. 2013 Nov;23(11):3185-90. doi: 10.1007/s00330-013-2922-y. Epub 2013 Jun 12.
- Background: PubMed 28723529Kuru TH, Herden J, Zugor V, Akbarov I, Pfister D, Porres D, Heidenreich A. How to Perform Image-guided Prostate Biopsy: In-bore and Fusion Approaches. Eur Urol Focus. 2016 Jun;2(2):151-153. doi: 10.1016/j.euf.2016.03.016. Epub 2016 Apr 12.
- Background: PubMed 26116294Arsov C, Rabenalt R, Blondin D, Quentin M, Hiester A, Godehardt E, Gabbert HE, Becker N, Antoch G, Albers P, Schimmoller L. Prospective randomized trial comparing magnetic resonance imaging (MRI)-guided in-bore biopsy to MRI-ultrasound fusion and transrectal ultrasound-guided prostate biopsy in patients with prior negative biopsies. Eur Urol. 2015 Oct;68(4):713-20. doi: 10.1016/j.eururo.2015.06.008. Epub 2015 Jun 23.
- Background: PubMed 24866597Quentin M, Blondin D, Arsov C, Schimmoller L, Hiester A, Godehardt E, Albers P, Antoch G, Rabenalt R. Prospective evaluation of magnetic resonance imaging guided in-bore prostate biopsy versus systematic transrectal ultrasound guided prostate biopsy in biopsy naive men with elevated prostate specific antigen. J Urol. 2014 Nov;192(5):1374-9. doi: 10.1016/j.juro.2014.05.090. Epub 2014 May 24.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Kantonsspital Winterthur KSW at 1 site in Switzerland.
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 5 inclusion and 2 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: finished, as of the sponsor's last update on 22 Aug 2018. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gleason score (minimum 2 to maximum of 10) (time frame: 01.09.2015 - 30.03.2017). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03615131, which also lists 36 linked publications.
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 22 Aug 2018.