Health Status UnknownNCT02501759
Transrectal MRI-Guided Biopsy in Identifying Cancer in Patients With Suspected Prostate Cancer
A study testing 3 Tesla Magnetic Resonance Imaging, Gadodiamide and Multiparametric Magnetic Resonance Imaging in people with Health Status Unknown and Prostate Carcinoma, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial summary
This pilot clinical trial studies transrectal magnetic resonance imaging (MRI)-guided biopsy to see how well it works in identifying cancer in patients with suspected prostate cancer who are scheduled to undergo standard biopsy. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Health Status Unknown, Prostate Carcinoma
- What is being tested?
- 3 Tesla Magnetic Resonance Imaging, Gadodiamide and Multiparametric Magnetic Resonance Imaging
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to 10 Feb 2017
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Scheduled TRUS-guided biopsy because of clinically suspected prostate cancer (abnormal serum prostate-specific antigen [PSA] level and/or abnormal digital rectal examination)
- No treatment for prostate cancer has been administered or will be administered before TRUS guided biopsy
- Patient willing to undergo scheduled standard of care TRUS guided biopsy
- Patient willing and able to provide written informed consent, including willingness to undergo both endorectal multiparametric MRI and transrectal MRI-guided biopsy at Oregon Health \& Science University (OHSU)
- Laboratory values and anticoagulation management per consensus guidelines, including:
- International normalized ratio (INR) >= 1.5
- Platelets >= 50,000
Who cannot join
- Known contraindication to MRI (e.g., severe claustrophobia, intracranial aneurysm clips, intraocular metallic foreign body, cardiac pacemaker); an extensive screening questionnaire will be completed by the subject as part of standard OHSU MRI safety measures
- Known contraindication to intravenous gadolinium contrast administration (e.g., renal impairment, known allergy); standard institutional policies on gadolinium and renal function will be followed
- Contraindication to placement of endorectal MRI coil, biopsy device or ultrasound probe (e.g., severe hemorrhoids, anal fissure, recent rectal surgery, or prior abdominoperineal resection)
- Previous inclusion in the study (e.g., a patient who has had negative TRUS and MRI-guided biopsies but continues to have a rising PSA)
- Active urinary tract infection
- Member of vulnerable population including prisoners or mentally disabled patients, in accordance with U.S. Department of Health and Human Services (DHHS) definitions
Trial locations and contacts
1 site in 1 country.
United States1 site
OHSU Knight Cancer Institute
Portland, Oregon, 97239
About this study
Official title: Pilot Study of Transrectal Multiparametric MRI-Guided Biopsy: Role in Prostate Cancer Evaluation
This pilot clinical trial studies transrectal magnetic resonance imaging (MRI)-guided biopsy to see how well it works in identifying cancer in patients with suspected prostate cancer who are scheduled to undergo standard biopsy. Transrectal MRI-guided biopsy uses a thin needle inserted through the rectum into the prostate and takes a sample of tissue, guided by MRI. MRI uses magnets to take pictures of the prostate and may be able to identify cancer. Transrectal MRI-guided biopsy may be more accurate and cause patients less pain than standard ultrasound-guided biopsy. It is not yet known whether transrectal MRI-guided biopsy is more effective than ultrasound-guided biopsy in identifying prostate cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To improve the treatment of patients with prostate cancer utilizing diagnostic multi-parametric magnetic resonance imaging (MRI) and MRI-guided prostate biopsy combined with molecular and clinical data to help determine the extent of prostate cancer and risk of disease progression.
II. To determine the relative accuracy of transrectal MRI-guided versus ultrasound-guided biopsy for the diagnosis of prostate cancer in patients with an appropriate dominant target lesion at multiparametric MRI, using pooled cancer diagnoses by either MRI-guided or ultrasound-guided biopsy as the reference standard.
III. To determine the proportion of positive transrectal MRI-guided biopsies that demonstrate a higher Gleason score than contemporaneous transrectal ultrasound guided biopsy.
IV. To determine the management impact of transrectal MRI-targeted biopsy results as compared to transrectal ultrasound (TRUS)-guided systematic biopsy results.
OUTLINE:
Patients receive gadodiamide intravenously (IV) and undergo a diagnostic multiparametric endorectal MRI. Patients with lesions visible on the diagnostic multiparametric endorectal MRI undergo transrectal MRI-guided biopsy within 2 weeks of diagnostic multiparametric endorectal MRI. Patients then undergo TRUS-guided biopsy per standard clinical care approximately 2 weeks after transrectal MRI-guided biopsy.
- Conditions
- Health Status Unknown, Prostate Carcinoma
- Being tested
- 3 Tesla Magnetic Resonance Imaging, Gadodiamide, Multiparametric Magnetic Resonance Imaging, Transrectal Biopsy, Ultrasound-Guided Prostate Biopsy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 Tesla Magnetic Resonance ImagingProcedure or surgery
Also called 3 Tesla MRI, 3T MRI
Undergo diagnostic multiparametric endorectal MRI with gadodiamide contrast
GadodiamideRadiation
Also called DV 7572, Gadolinium-DTPA-BMA, Gd-DTPA-BMA, HSDB 7547
Given IV
Multiparametric Magnetic Resonance ImagingProcedure or surgery
Also called Multiparametric MRI
Undergo diagnostic multiparametric endorectal MRI with gadodiamide contrast
Transrectal BiopsyProcedure or surgery
Also called Transrectal Prostate Biopsy
Undergo transrectal MRI-guided biopsy
Ultrasound-Guided Prostate BiopsyProcedure or surgery
Undergo TRUS-guided biopsy
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (MRI, MRI-guided biopsy, TRUS-guided biopsy) | Experimental | Patients receive gadodiamide IV and undergo a diagnostic multiparametric endorectal MRI. Patients with lesions visible on the diagnostic multiparametric endorectal MRI undergo transrectal MRI-guided biopsy within 2 weeks of diagnostic multiparametric endorectal MRI. Patients then undergo TRUS-guided biopsy per standard clinical care approximately 2 weeks after transrectal MRI-guided biopsy. Receives: Procedure: 3 Tesla Magnetic Resonance Imaging; Radiation: Gadodiamide; Procedure: Multiparametric Magnetic Resonance Imaging; Procedure: Transrectal Biopsy; Procedure: Ultrasound-Guided Prostate Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of MRI-guided Biopsies That Demonstrate a Higher Gleason Score Than Contemporaneous TRUS Guided Biopsy
The proportion of MRI-guided biopsies that demonstrate a higher Gleason score than contemporaneous TRUS guided biopsy for all patients diagnosed of prostate cancer based on the reference standard will be estimated. McNemar's test will be used to assess whether the MRI-guided biopsies are more likely to yield a higher Gleason score compared with TRUS guided biopsy. Simple logistic regression model will be used to assess the association between the higher Gleason score and patient characteristics and/or clinical information for patients diagnosed of prostate cancer.
Measured: Up to 42 days (6 weeks)
Sensitivity of MRI-guided Biopsy
The presence of cancer on either biopsy or absence of cancer on both will be used as the reference standard. For comparison of the two methods, the 2X2 matched sample tables will be presented, and the difference in sensitivity estimated. The relative accuracy of MRI- versus TRUS-guided biopsy will be compared using McNemar's test. To explore potential associations between the accuracy of each method with patient characteristics and/or clinical information, a binary endpoint will be created to reflect agreement between each method and the reference standard.
Measured: Up to 2 weeks after diagnostic MRI
Sensitivity of TRUS-guided Biopsy
The presence of cancer on either biopsy or absence of cancer on both will be used as the reference standard. For comparison of the two methods, the 2X2 matched sample tables will be presented, and the difference in sensitivity estimated. The relative accuracy of MRI- versus TRUS-guided biopsy will be compared using McNemar's test. To explore potential associations between the accuracy of each method with patient characteristics and/or clinical information, a binary endpoint will be created to reflect agreement between each method and the reference standard.
Measured: Up to 2 weeks after MRI-guided biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2015 (estimated)
- Study startMay 2015
- Primary completion31 Dec 2016
- Study completion10 Feb 2017
Why it stopped: Low enrollment and funding loss.
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.
- Other trials for Health Status UnknownStudies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe 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
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Foundation, Oregon, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Fergus Coakley, OHSU Knight Cancer Institute
- Investigators
- Fergus Coakley, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02501759
- Sponsor's protocol ID
- IRB00010086
- Other IDs
- NCI-2015-00930, SOL-13142-LM, IRB00010086, P30CA069533
- Status last verified
- Mar 2019
- First submitted
- 15 Jul 2015
- Last updated
- 3 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Transrectal Multiparametric MRI-Guided Biopsy: Role in Prostate Cancer Evaluation
- ClinicalTrials.gov ID
- NCT02501759
- Acronym / sponsor ID
- IRB00010086
- Conditions
- Health Status Unknown, Prostate Carcinoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment and funding loss.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- Medical Research Foundation, Oregon, National Cancer Institute (NCI)
- Study start
- May 2015
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 10 Feb 2017 (actual)
- First posted
- 17 Jul 2015 (estimated)
- Results
- Posted 3 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot clinical trial studies transrectal magnetic resonance imaging (MRI)-guided biopsy to see how well it works in identifying cancer in patients with suspected prostate cancer who are scheduled to undergo standard biopsy. Transrectal MRI-guided biopsy uses a thin needle inserted through the rectum into the prostate and takes a sample of tissue, guided by MRI. MRI uses magnets to take pictures of the prostate and may be able to identify cancer. Transrectal MRI-guided biopsy may be more accurate and cause patients less pain than standard ultrasound-guided biopsy. It is not yet known whether transrectal MRI-guided biopsy is more effective than ultrasound-guided biopsy in identifying prostate cancer.
Detailed description
PRIMARY OBJECTIVES:
- To improve the treatment of patients with prostate cancer utilizing diagnostic multi-parametric magnetic resonance imaging (MRI) and MRI-guided prostate biopsy combined with molecular and clinical data to help determine the extent of prostate cancer and risk of disease progression.
II. To determine the relative accuracy of transrectal MRI-guided versus ultrasound-guided biopsy for the diagnosis of prostate cancer in patients with an appropriate dominant target lesion at multiparametric MRI, using pooled cancer diagnoses by either MRI-guided or ultrasound-guided biopsy as the reference standard.
III. To determine the proportion of positive transrectal MRI-guided biopsies that demonstrate a higher Gleason score than contemporaneous transrectal ultrasound guided biopsy.
IV. To determine the management impact of transrectal MRI-targeted biopsy results as compared to transrectal ultrasound (TRUS)-guided systematic biopsy results.
OUTLINE:
Patients receive gadodiamide intravenously (IV) and undergo a diagnostic multiparametric endorectal MRI. Patients with lesions visible on the diagnostic multiparametric endorectal MRI undergo transrectal MRI-guided biopsy within 2 weeks of diagnostic multiparametric endorectal MRI. Patients then undergo TRUS-guided biopsy per standard clinical care approximately 2 weeks after transrectal MRI-guided biopsy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (MRI, MRI-guided biopsy, TRUS-guided biopsy) | Experimental | Procedure: 3 Tesla Magnetic Resonance Imaging, Radiation: Gadodiamide, Procedure: Multiparametric Magnetic Resonance Imaging, Procedure: Transrectal Biopsy, Procedure: Ultrasound-Guided Prostate BiopsyPatients receive gadodiamide IV and undergo a diagnostic multiparametric endorectal MRI. Patients with lesions visible on the diagnostic multiparametric endorectal MRI undergo transrectal MRI-guided biopsy within 2 weeks of diagnostic multiparametric endorectal MRI. Patients then undergo TRUS-guided biopsy per standard clinical care approximately 2 weeks after transrectal MRI-guided biopsy. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Scheduled TRUS-guided biopsy because of clinically suspected prostate cancer (abnormal serum prostate-specific antigen [PSA] level and/or abnormal digital rectal examination)
- No treatment for prostate cancer has been administered or will be administered before TRUS guided biopsy
- Patient willing to undergo scheduled standard of care TRUS guided biopsy
- Patient willing and able to provide written informed consent, including willingness to undergo both endorectal multiparametric MRI and transrectal MRI-guided biopsy at Oregon Health \& Science University (OHSU)
- Laboratory values and anticoagulation management per consensus guidelines, including:
Key exclusion criteria (6 listed)
- Known contraindication to MRI (e.g., severe claustrophobia, intracranial aneurysm clips, intraocular metallic foreign body, cardiac pacemaker); an extensive screening questionnaire will be completed by the subject as part of standard OHSU MRI safety measures
- Known contraindication to intravenous gadolinium contrast administration (e.g., renal impairment, known allergy); standard institutional policies on gadolinium and renal function will be followed
- Contraindication to placement of endorectal MRI coil, biopsy device or ultrasound probe (e.g., severe hemorrhoids, anal fissure, recent rectal surgery, or prior abdominoperineal resection)
- Previous inclusion in the study (e.g., a patient who has had negative TRUS and MRI-guided biopsies but continues to have a rising PSA)
- Active 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 |
|---|---|---|
| 3 Tesla Magnetic Resonance ImagingAlso: 3 Tesla MRI, 3T MRIUndergo diagnostic multiparametric endorectal MRI with gadodiamide contrast | Procedure or surgery | Diagnostic (MRI, MRI-guided biopsy, TRUS-guided biopsy) |
| GadodiamideAlso: DV 7572, Gadolinium-DTPA-BMA, Gd-DTPA-BMA, HSDB 7547Given IV | Radiation | Diagnostic (MRI, MRI-guided biopsy, TRUS-guided biopsy) |
| Multiparametric Magnetic Resonance ImagingAlso: Multiparametric MRIUndergo diagnostic multiparametric endorectal MRI with gadodiamide contrast | Procedure or surgery | Diagnostic (MRI, MRI-guided biopsy, TRUS-guided biopsy) |
| Transrectal BiopsyAlso: Transrectal Prostate BiopsyUndergo transrectal MRI-guided biopsy | Procedure or surgery | Diagnostic (MRI, MRI-guided biopsy, TRUS-guided biopsy) |
| Ultrasound-Guided Prostate BiopsyUndergo TRUS-guided biopsy | Procedure or surgery | Diagnostic (MRI, MRI-guided biopsy, TRUS-guided biopsy) |
Primary outcome
Proportion of MRI-guided Biopsies That Demonstrate a Higher Gleason Score Than Contemporaneous TRUS Guided Biopsy
Time frame: Up to 42 days (6 weeks)
The proportion of MRI-guided biopsies that demonstrate a higher Gleason score than contemporaneous TRUS guided biopsy for all patients diagnosed of prostate cancer based on the reference standard will be estimated. McNemar's test will be used to assess whether the MRI-guided biopsies are more likely to yield a higher Gleason score compared with TRUS guided biopsy. Simple logistic regression model will be used to assess the association between the higher Gleason score and patient characteristics and/or clinical information for patients diagnosed of prostate cancer.
Sensitivity of MRI-guided Biopsy
Time frame: Up to 2 weeks after diagnostic MRI
The presence of cancer on either biopsy or absence of cancer on both will be used as the reference standard. For comparison of the two methods, the 2X2 matched sample tables will be presented, and the difference in sensitivity estimated. The relative accuracy of MRI- versus TRUS-guided biopsy will be compared using McNemar's test. To explore potential associations between the accuracy of each method with patient characteristics and/or clinical information, a binary endpoint will be created to reflect agreement between each method and the reference standard.
Sensitivity of TRUS-guided Biopsy
Time frame: Up to 2 weeks after MRI-guided biopsy
The presence of cancer on either biopsy or absence of cancer on both will be used as the reference standard. For comparison of the two methods, the 2X2 matched sample tables will be presented, and the difference in sensitivity estimated. The relative accuracy of MRI- versus TRUS-guided biopsy will be compared using McNemar's test. To explore potential associations between the accuracy of each method with patient characteristics and/or clinical information, a binary endpoint will be created to reflect agreement between each method and the reference standard.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Fergus Coakley principal investigator
OHSU Knight Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3 Tesla Magnetic Resonance Imaging, Gadodiamide and Multiparametric Magnetic Resonance Imaging in people with Health Status Unknown and Prostate Carcinoma, run by OHSU Knight Cancer Institute 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 7 inclusion and 6 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: stopped early, as of the sponsor's last update on 3 Apr 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 3 Apr 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?
Proportion of MRI-guided Biopsies That Demonstrate a Higher Gleason Score Than Contemporaneous TRUS Guided Biopsy (time frame: Up to 42 days (6 weeks)). The study lists 3 primary outcomes in all. 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 3 Apr 2019.