Prostate CancerNCT03044197
Detection of Clinically Significant Prostate Cancer Using Transperineal Targeted Biopsy Compared to Standard Transrectal Biopsy
A study testing MRI/ultrasound transperineal prostate biopsy and transrectal ultrasound-guided prostate biopsy in people with Prostate Cancer and Magnetic Resonance Imaging, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
Prostate biopsies are currently the gold standard for the diagnosis of prostate cancer. Many biopsies, however, are unnecessary or cannot detect significant prostate cancer (PCa). Read more about this study
- Who is it for?
- Ages 18 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer, Magnetic Resonance Imaging, Target Lesion
- What is being tested?
- MRI/ultrasound transperineal prostate biopsy and transrectal ultrasound-guided prostate biopsy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2017to 12 Apr 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males aged 18-75 years old
- PSA >1 ng/ml but <15 ng/ml
- Negative DRE
- Signed informed consent
Who cannot join
- Previous prostate biopsy or prostate surgery
- Previous prostate mpMRI
- Contraindication to mpMRI: patients with pacemakers, defibrillators or other implanted electronic devices
- Patients in the Texas Department of Criminal Justice (prisoners)
- Patients with acute urinary symptoms including urinary retention and urinary tract infection
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Medical Branch at Galveston
Galveston, Texas, 77555
About this study
Official title: Assessing the Detection of Clinically Significant Prostate Cancer Using Magnetic Resonance Imaging-Guided Transperineal Targeted Biopsy Compared to Standard Transrectal Biopsy Outcomes Study: The ASTROS Trial
Prostate biopsies are currently the gold standard for the diagnosis of prostate cancer. Many biopsies, however, are unnecessary or cannot detect significant prostate cancer (PCa). With multi-parametric magnetic resonance imaging (mpMRI) we now potentially have a way of increasing the detection of detecting clinically significant prostate cancer (csPCa) while decreasing the detection of non-significant PCa.
Read the detailed description
In men with previously negative prostate biopsy and persistent elevated prostate-specific antigen (PSA) value, it is unclear which biopsy strategy offers the highest detection rate for significant prostate cancer. The hypothesis of this study is that targeted MRI/ultrasound fusion-guided biopsy improves the detection rates of clinically significant prostate cancers (csPCa) compared with systematic transrectal ultrasound-guided prostate biopsy.
Patients who fulfill all eligibility criteria and have provided written consent will be randomized to undergo MRI followed by biopsies (arm A) or TRUS transrectal biopsy (arm-B). Patients will be randomly assigned to arm A or arm B following a 1:1 simple randomization procedure according to a computer-generated randomization list. The primary end point will be the comparison of detection rates csPCa between arm A and arm B. csPCa will be defined according to the Standards of Reporting for MRI-targeted Biopsy Studies (START) criteria for targeted biopsy Gleason Score ≥ 7 or maximum CCL ≥ 5 mm and the updated Epstein criteria for SB (Gleason score ≥ 7, PSA density ≥ 0.15, Gleason score ≥ 2 positive cores, and bilateral cancer). The secondary end points will be (1) Comparison of the overall detection rate of PCa and csPCa between arm A mpMRI+ and arm B and (2) Comparison of complication rates between arm A mpMRI+ and arm B.
- Conditions
- Prostate Cancer, Magnetic Resonance Imaging, Target Lesion, Fusion Biopsy, Clinically Significant Prostate Cancer, Transperineal
- Being tested
- MRI/ultrasound transperineal prostate biopsy, transrectal ultrasound-guided prostate biopsy
- Keywords
- prostate cancer, magnetic resonance imaging, transperineal biopsy, target lesion, fusion biopsy
- Medical subject headings
- Prostatic Neoplasms, Erythema Multiforme
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI/ultrasound transperineal prostate biopsyDevice
3-6 targeted biopsy cores from each prostate region of interest
transrectal ultrasound-guided prostate biopsyDevice
12 systematic biopsy cores
| Study group | Role | What they receive |
|---|---|---|
| MRI/ultrasound transperineal prostate biopsy | Experimental | In arm A, all patients with positive mpMRI evidence of lesions suspicious for PCa, i.e. PI RADS ≥ 3 will be submitted to transperineal mpMRI-targeted prostate biopsy (arm A MRI+). The gland and the regions of interest will be contoured, and the prostate contour will be fused in real time with the TRUS image. Biopsies will be performed via a transperineal approach in the operating room. The patient will be placed in dorsal lithotomy position. mpMRI-targeted biopsies will be performed on regions of interest, and three to six cores will be obtained for biopsy from each lesion and is standard of care according to START criteria for targeted biopsy. In cases of negative mpMRI results i.e. PI RADS<3, arm A patients will undergo TRUS-guided transrectal 12-core prostate biopsy (arm A MRI-) as described in arm B. Receives: Device: MRI/ultrasound transperineal prostate biopsy |
| transrectal ultrasound-guided prostate biopsy | Active comparator | TRUS-guided transrectal prostate biopsy will be performed using a disposable 18-gauge biopsy gun with a specimen size of 18-22 mm (Bard Medical, Covington, GA, USA). The 12 cores will be obtained from 12 separate anatomical regions of the prostate which is standard practice in performing TRUS-guided transrectal prostate biopsy: left medial apex, left lateral apex, left medial midgland, left lateral midgland, left medial base, left lateral base, right medial apex, right lateral apex, right medial midgland, right lateral midgland, right medial base and right lateral base. Receives: Device: transrectal ultrasound-guided prostate biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Clinically Significant Prostate Cancer
Number of subjects with positive clinically significant prostate cancer results
Measured: Within 2-4 wks after biopsy
Secondary outcomes (2)
Overall Detection Rate of Prostate Cancer Between Arm A mpMRI+ and Arm B
Number of overall positive prostate cancer (Combined positive and clinically significant positive results) Not all positive prostate biopsies are considered clinically significant. Clinically significant results indicate further work up and/or treatment. Physicians and patients may choose not to just monitor non-clinically significant prostate results for future changes. The overall detection rate will report the total number of both non-clinically significant positive results and clinically significant results.
Measured: Within 2-4 wks from biopsy
Comparison of UTI Incidence in Arm A mpMRI+ and Arm B
Number of confirmed UTIs
Measured: From the time of biopsy through 4 weeks post-biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2017 (estimated)
- Study start25 Jul 2017
- Primary completion12 Apr 2018
- Study completion12 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomly assigned to arm A or arm B following a 1:1 simple randomization procedure according to a computer-generated randomization list.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen B Williams, MD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03044197
- Sponsor's protocol ID
- 17-0013
- Status last verified
- Apr 2019
- First submitted
- 2 Feb 2017
- Last updated
- 5 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Kosarek CD, Mahmoud AM, Eyzaguirre EJ, Shan Y, Walser EM, Horn GL, Williams SB. Initial series of magnetic resonance imaging (MRI)-fusion targeted prostate biopsy using the first transperineal targeted platform available in the USA. BJU Int. 2018 Nov;122(5):909-912. doi: 10.1111/bju.14206. Epub 2018 Apr 14.
PubMed 29569311
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Detection of Clinically Significant Prostate Cancer Using Magnetic Resonance Imaging-Guided Transperineal Targeted Biopsy Compared to Standard Transrectal Biopsy Outcomes Study: The ASTROS Trial
- ClinicalTrials.gov ID
- NCT03044197
- Acronym / sponsor ID
- 17-0013
- Conditions
- Prostate Cancer, Magnetic Resonance Imaging, Target Lesion, Fusion Biopsy, Clinically Significant Prostate Cancer, Transperineal
- Keywords
- prostate cancer, magnetic resonance imaging, transperineal biopsy, target lesion, fusion biopsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 25 Jul 2017 (actual)
- Primary completion
- 12 Apr 2018 (actual)
- Study completion
- 12 Apr 2018 (actual)
- First posted
- 6 Feb 2017 (estimated)
- Results
- Posted 9 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prostate biopsies are currently the gold standard for the diagnosis of prostate cancer. Many biopsies, however, are unnecessary or cannot detect significant prostate cancer (PCa). With multi-parametric magnetic resonance imaging (mpMRI) we now potentially have a way of increasing the detection of detecting clinically significant prostate cancer (csPCa) while decreasing the detection of non-significant PCa.
Detailed description
In men with previously negative prostate biopsy and persistent elevated prostate-specific antigen (PSA) value, it is unclear which biopsy strategy offers the highest detection rate for significant prostate cancer. The hypothesis of this study is that targeted MRI/ultrasound fusion-guided biopsy improves the detection rates of clinically significant prostate cancers (csPCa) compared with systematic transrectal ultrasound-guided prostate biopsy.
Patients who fulfill all eligibility criteria and have provided written consent will be randomized to undergo MRI followed by biopsies (arm A) or TRUS transrectal biopsy (arm-B). Patients will be randomly assigned to arm A or arm B following a 1:1 simple randomization procedure according to a computer-generated randomization list. The primary end point will be the comparison of detection rates csPCa between arm A and arm B. csPCa will be defined according to the Standards of Reporting for MRI-targeted Biopsy Studies (START) criteria for targeted biopsy Gleason Score ≥ 7 or maximum CCL ≥ 5 mm and the updated Epstein criteria for SB (Gleason score ≥ 7, PSA density ≥ 0.15, Gleason score ≥ 2 positive cores, and bilateral cancer). The secondary end points will be (1) Comparison of the overall detection rate of PCa and csPCa between arm A mpMRI+ and arm B and (2) Comparison of complication rates between arm A mpMRI+ and arm B.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomly assigned to arm A or arm B following a 1:1 simple randomization procedure according to a computer-generated randomization list.
| Arm | Type | Receives |
|---|---|---|
| MRI/ultrasound transperineal prostate biopsy | Experimental | Device: MRI/ultrasound transperineal prostate biopsyIn arm A, all patients with positive mpMRI evidence of lesions suspicious for PCa, i.e. PI RADS ≥ 3 will be submitted to transperineal mpMRI-targeted prostate biopsy (arm A MRI+). The gland and the regions of interest will be contoured, and the prostate contour will be fused in real time with the TRUS image. Biopsies will be performed via a transperineal approach in the operating room. The patient will be placed in dorsal lithotomy position. mpMRI-targeted biopsies will be performed on regions of interest, and three to six cores will be obtained for biopsy from each lesion and is standard of care according to START criteria for targeted biopsy. In cases of negative mpMRI results i.e. PI RADS<3, arm A patients will undergo TRUS-guided transrectal 12-core prostate biopsy (arm A MRI-) as described in arm B. |
| transrectal ultrasound-guided prostate biopsy | Active comparator | Device: transrectal ultrasound-guided prostate biopsyTRUS-guided transrectal prostate biopsy will be performed using a disposable 18-gauge biopsy gun with a specimen size of 18-22 mm (Bard Medical, Covington, GA, USA). The 12 cores will be obtained from 12 separate anatomical regions of the prostate which is standard practice in performing TRUS-guided transrectal prostate biopsy: left medial apex, left lateral apex, left medial midgland, left lateral midgland, left medial base, left lateral base, right medial apex, right lateral apex, right medial midgland, right lateral midgland, right medial base and right lateral base. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males aged 18-75 years old
- PSA >1 ng/ml but <15 ng/ml
- Negative DRE
- Signed informed consent
Key exclusion criteria (5 listed)
- Previous prostate biopsy or prostate surgery
- Previous prostate mpMRI
- Contraindication to mpMRI: patients with pacemakers, defibrillators or other implanted electronic devices
- Patients in the Texas Department of Criminal Justice (prisoners)
- Patients with acute urinary symptoms including urinary retention and urinary tract infection
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/ultrasound transperineal prostate biopsy3-6 targeted biopsy cores from each prostate region of interest | Device | MRI/ultrasound transperineal prostate biopsy |
| transrectal ultrasound-guided prostate biopsy12 systematic biopsy cores | Device | transrectal ultrasound-guided prostate biopsy |
Primary outcome
Number of Participants With Clinically Significant Prostate Cancer
Time frame: Within 2-4 wks after biopsy
Number of subjects with positive clinically significant prostate cancer results
2 secondary outcomes
Overall Detection Rate of Prostate Cancer Between Arm A mpMRI+ and Arm B
Time frame: Within 2-4 wks from biopsy
Comparison of UTI Incidence in Arm A mpMRI+ and Arm B
Time frame: From the time of biopsy through 4 weeks post-biopsy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29569311Kosarek CD, Mahmoud AM, Eyzaguirre EJ, Shan Y, Walser EM, Horn GL, Williams SB. Initial series of magnetic resonance imaging (MRI)-fusion targeted prostate biopsy using the first transperineal targeted platform available in the USA. BJU Int. 2018 Nov;122(5):909-912. doi: 10.1111/bju.14206. Epub 2018 Apr 14.
- Individual participant dataSharing planned: No
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.
Stephen B Williams, MD principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI/ultrasound transperineal prostate biopsy and transrectal ultrasound-guided prostate biopsy in people with Prostate Cancer and Magnetic Resonance Imaging, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
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 4 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: finished, as of the sponsor's last update on 5 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 United States. 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?
Yes. Results are posted in the registry (first posted 9 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Clinically Significant Prostate Cancer (time frame: Within 2-4 wks after biopsy). 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 NCT03044197, which also lists 1 linked publication.
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 5 Jun 2019.