Prostate CancerNCT03823001
Virtual Prostate Biopsy Protocol for Patients on Active Surveillance and at Risk of Prostate Cancer
A study testing virtual biopsy (VB) monitoring protocol in people with Prostate Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to examine the use of MRI surveillance for patients with no prostate cancer, potential prostate cancer, or diagnosed low-grade prostate cancer. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- virtual biopsy (VB) monitoring protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2022to Jun 2023
- 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
- Biopsy-naive patients with a negative prostate MRI (PI-RADS score 1 or 2); or
- Patients with a PI-RADS score of 3, 4, or 5 on MRI and a negative MR-targeted biopsy; or
- Patients on active surveillance with a negative prostate MRI (PI-RADS 1 or 2).
Who cannot join
- Positive DRE;
- PSA > 10 ng/ml or unstable PSA (doubling time <3 years) during the last year prior to enrolling in this study;
- PSAD > 0.15 (calculated using most recent PSA divided by MRI prostate volume);
- First degree relative diagnosed with prostate cancer
- First degree relative diagnosed with a BRCA2 or Lynch syndrome associated gene causing any cancer.
- Patient carries a mutation on BRCA2 or a mismatch repair gene associated with Lynch syndrome (MLHl, MSH2, MSH6, PMS2); known BRCA2 or known mismatch repair gene mutation in the family (Lynch Syndrome) and patient has not had testing; or family history consistent with BRCA2 or Lynch syndrome and there is no known BRCA2 or mismatch repair gene in the family.
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
About this study
Official title: Evaluation of a Novel, Non-Invasive Virtual Prostate Biopsy Protocol for Patients on Active Surveillance and Patients at Risk of Harboring Low-Risk Prostate Cancer: A Prospective Non-Randomized Clinical Trial
The purpose of this study is to examine the use of MRI surveillance for patients with no prostate cancer, potential prostate cancer, or diagnosed low-grade prostate cancer.
Read the detailed description
This study will use MRI instead of prostate biopsy in combination with regularly scheduled urologist visits, interval PSA checks, and annual DRE to help establish a non-invasive method for 1) participants with a negative prostate MRI (PI-RADS 1 or 2) who have never had a biopsy; 2) participants with a positive MRI (PI-RADS score of 3, 4, or 5) and negative MRI-targeted biopsy pathology; and 3) monitoring participants with clinically diagnosed low risk prostate cancer who are on active surveillance. However, if at any point, clinical suspicion indicated either by the presence of suspicious lesions on the MRI, rising PSA, and/or positive DRE arises, then an immediate biopsy will be performed.
- Conditions
- Prostate Cancer
- Being tested
- virtual biopsy (VB) monitoring protocol
- Keywords
- Magnetic Resonance Imaging (MRI)
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual biopsy (VB) monitoring protocolDiagnostic test
- PSA bi-annually or more often according to the discretion of the urologist.
- Annual DRE.
- Visit with the urologist bi-annually.
- Multi-parametric MRI (mpMRI) every year for 3 years.
- Transrectal ultrasound (TRUS) biopsy at the end of the 3rd year.
| Study group | Role | What they receive |
|---|---|---|
| Virtual prostate biopsy (VB) monitoring | Experimental | Prostate-specific antigen (PSA) and digital rectal exam (DRE) are standard of care for monitoring patients on active surveillance or at risk of having low-risk prostate cancer. A novel virtual biopsy (VB) monitoring protocol will be implemented:
1. PSA bi-annually or more often according to the discretion of the urologist.
2. Annual DRE.
3. Visit with the urologist bi-annually.
4. Multi-parametric MRI (mpMRI) every year for 3 years.
5. Transrectal ultrasound (TRUS) biopsy at the end of the 3rd year. Receives: Diagnostic Test: virtual biopsy (VB) monitoring protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Negative predictive value (NPV) of MRI (adjusted to the prostate VB protocol criteria)
Negative predictive value (NPV) of MRI (adjusted to the prostate VB protocol criteria). This metric will determine if the the VB protocol is statistically equal to (or greater than) the negative predictive value of the standard of care TRUS prostate biopsy.
Measured: Up to 3 years from start of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study startOct 2022 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionJun 2023 (estimated)
Why it stopped: low accrual
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 Case Comprehensive Cancer CenterThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lee Ponsky, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03823001
- Sponsor's protocol ID
- CASE9818
- Status last verified
- May 2022
- First submitted
- 28 Jan 2019
- Last updated
- 20 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the published article, after deidentification (text, tables, figures).
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Novel, Non-Invasive Virtual Prostate Biopsy Protocol for Patients on Active Surveillance and Patients at Risk of Harboring Low-Risk Prostate Cancer: A Prospective Non-Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03823001
- Acronym / sponsor ID
- CASE9818
- Conditions
- Prostate Cancer
- Keywords
- Magnetic Resonance Imaging (MRI)
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: low accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Oct 2022 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 30 Jan 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.
The purpose of this study is to examine the use of MRI surveillance for patients with no prostate cancer, potential prostate cancer, or diagnosed low-grade prostate cancer.
Detailed description
This study will use MRI instead of prostate biopsy in combination with regularly scheduled urologist visits, interval PSA checks, and annual DRE to help establish a non-invasive method for 1) participants with a negative prostate MRI (PI-RADS 1 or 2) who have never had a biopsy; 2) participants with a positive MRI (PI-RADS score of 3, 4, or 5) and negative MRI-targeted biopsy pathology; and 3) monitoring participants with clinically diagnosed low risk prostate cancer who are on active surveillance. However, if at any point, clinical suspicion indicated either by the presence of suspicious lesions on the MRI, rising PSA, and/or positive DRE arises, then an immediate biopsy will be performed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual prostate biopsy (VB) monitoring | Experimental | Diagnostic Test: virtual biopsy (VB) monitoring protocolProstate-specific antigen (PSA) and digital rectal exam (DRE) are standard of care for monitoring patients on active surveillance or at risk of having low-risk prostate cancer. A novel virtual biopsy (VB) monitoring protocol will be implemented: 1. PSA bi-annually or more often according to the discretion of the urologist. 2. Annual DRE. 3. Visit with the urologist bi-annually. 4. Multi-parametric MRI (mpMRI) every year for 3 years. 5. Transrectal ultrasound (TRUS) biopsy at the end of the 3rd year. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Biopsy-naive patients with a negative prostate MRI (PI-RADS score 1 or 2); or
- Patients with a PI-RADS score of 3, 4, or 5 on MRI and a negative MR-targeted biopsy; or
- Patients on active surveillance with a negative prostate MRI (PI-RADS 1 or 2).
Key exclusion criteria (6 listed)
- Positive DRE;
- PSA > 10 ng/ml or unstable PSA (doubling time <3 years) during the last year prior to enrolling in this study;
- PSAD > 0.15 (calculated using most recent PSA divided by MRI prostate volume);
- First degree relative diagnosed with prostate cancer
- First degree relative diagnosed with a BRCA2 or Lynch syndrome associated gene causing any cancer.
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 |
|---|---|---|
| virtual biopsy (VB) monitoring protocol1. PSA bi-annually or more often according to the discretion of the urologist. 2. Annual DRE. 3. Visit with the urologist bi-annually. 4. Multi-parametric MRI (mpMRI) every year for 3 years. 5. Transrectal ultrasound (TRUS) biopsy at the end of the 3rd year. | Diagnostic test | Virtual prostate biopsy (VB) monitoring |
Primary outcome
Negative predictive value (NPV) of MRI (adjusted to the prostate VB protocol criteria)
Time frame: Up to 3 years from start of study
Negative predictive value (NPV) of MRI (adjusted to the prostate VB protocol criteria). This metric will determine if the the VB protocol is statistically equal to (or greater than) the negative predictive value of the standard of care TRUS prostate biopsy.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2022.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the published article, after deidentification (text, tables, figures).
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RecruitingPhase 2
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RecruitingPhase 3
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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.
Lee Ponsky principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual biopsy (VB) monitoring protocol in people with Prostate Cancer, run by Case Comprehensive Cancer Center 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 3 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: withdrawn, as of the sponsor's last update on 20 May 2022. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Negative predictive value (NPV) of MRI (adjusted to the prostate VB protocol criteria) (time frame: Up to 3 years from start of study). 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 20 May 2022.