Health Status UnknownNCT03234556
Diagnosing Clinically Significant Prostate Cancer In African American and White Men With Elevated PSA
A study testing Biopsy of Prostate, Laboratory Biomarker Analysis and Magnetic Resonance Imaging in people with Health Status Unknown and Elevated PSA, run by University of Southern California at 4 sites in United States.
Trial summary
This randomized phase II trial studies how well systematic random biopsy or magnetic resonance imaging (MRI)-ultrasound image (US) fusion biopsy work in diagnosing prostate cancer in patients with elevated prostate specific antigen. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Health Status Unknown, Elevated PSA
- What is being tested?
- Biopsy of Prostate, Laboratory Biomarker Analysis and Magnetic Resonance Imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 4 sitesUnited States
- Study dates
- 25 Sep 2017to 23 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information
- Note: HIPAA authorization may be included in the informed consent or obtained separately
- Eastern Cooperative Oncology Group (ECOG) performance status of =< 1 within 3 months (93 days) prior to being registered for protocol
- African-American or white men (Hispanic or non-Hispanic)
- Prostate biopsy-naive or a single negative biopsy
- Having elevated prostate specific antigen (PSA) (> 2.5 ng/ml) and no palpable nodule on digital rectal exam (DRE)
Show all 9Show fewer
- Ability to understand the willingness to sign a written informed consent
- Patients must be willing to undergo a radiologic imaging before and after biopsy of the prostate
- Patients must be willing to undergo a biopsy of the prostate
Who cannot join
- Patients who have had chemotherapy or radiotherapy within 12 months of the study for other diagnoses not related to prostate cancer
- Patients receiving any other investigational agents
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Patients with active inflammatory bowel disease
- Patients who are unable to undergo MRI
- Patients who had any surgery of the prostate including TURP (transurethral resection of the prostate)
- Patients who had > 1 prior prostate biopsy
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Maryland
Baltimore, Maryland, 21201
Henry Ford Hospital Vattikuti Urology Institute
Detroit, Michigan, 48202
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Diagnosing Clinically Significant Prostate Cancer in African American and White Men Phase II, Randomized Clinical Trial, Multi-center, MR-Guided vs. 12-core Systematic Random Biopsy, Localized Prostate Cancer
This randomized phase II trial studies how well systematic random biopsy or magnetic resonance imaging (MRI)-ultrasound image (US) fusion biopsy work in diagnosing prostate cancer in patients with elevated prostate specific antigen. Systematic random biopsy and MRI-US fusion biopsy may work better in improving the accuracy of prostate cancer detection.
Read the detailed description
PRIMARY OBJECTIVES:
- To compare the detection of clinically significant prostate cancer (CSPCa) in Arm 1 versus Arm 2.
II. To compare between African American (AA) and white men the probability of developing CSPCa within three years of initial biopsy at the start of the study.
SECONDARY OBJECTIVES:
- To determine complications and patient morbidity associated with either systematic random prostate biopsy (SR-Bx) versus (vs) magnetic resonance imaging-ultrasound image fusion biopsy (MRUS-Bx) + SR-Bx.
TERTIARY OBJECTIVES:
- To compare Gleason score between MRUS-Bx and radical prostatectomy (RP) specimen among men who elect RP (~110 in the randomized controlled trial [RCT]).
II. To assess within Arm 1 the detection of CSPCa three months after SR-Bx among men initially diagnosed with clinically insignificant prostate cancer (CinsPCa) or no cancer.
III. To identify among men invited to participate and those actually enrolled in the RCT: determinants of study participation.
IV. To identify among men invited to participate and those actually enrolled in the RCT: determinants of treatment decision (active surveillance [AS] vs radiation vs RP) including the diagnostic method.
OUTLINE: Patients are randomized into 1 of 2 arms.
ARM I: SR-Bx group
- Patients undergo SR-Bx
- If SR-Bx doesn't reveal clinically significant cancer, then MRI in 3 months, and if lesion is present (PIRADS ≥ 3) schedule for MRUS-Bx.
- If there is no lesion, then no biopsy - schedule MRI in 12 months after the initial MRI.
ARM II: MRUS-Bx group
- Patients undergo MRI. Must be scheduled at least 1 day before MRUS Biopsy.
- MRI shows no lesion present (PIRADS 1-2): no MRUS-Bx, schedule for SR-Bx only.
- MRI lesion present (PIRADS ≥ 3): schedule for MRUS-Bx, which will be done first and followed immediately after by SR-Bx.
FOLLOW UP:
After completion of procedure, patients are followed up at 2-4 weeks, 3, 6, 9, and 12 months, and then periodically for up to 5 years.
- Conditions
- Health Status Unknown, Elevated PSA
- Being tested
- Biopsy of Prostate, Laboratory Biomarker Analysis, Magnetic Resonance Imaging, MRI Ultrasound Fusion Guided Biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsy of ProstateProcedure or surgery
Also called Prostate Biopsy, Prostatic Biopsy
Undergo SR-Bx
Laboratory Biomarker AnalysisOther
Correlative studies
Magnetic Resonance ImagingDiagnostic test
Also called Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI Scan
Undergo MRI
MRI Ultrasound Fusion Guided BiopsyDiagnostic test
Also called Fusion Biopsy, Fusion-Guided Biopsy, MR Fusion Biopsy, MRI-Ultrasound Fusion Biopsy
Undergo MRUS-Bx
| Study group | Role | What they receive |
|---|---|---|
| Arm I (SR-Bx) | Active comparator | Patients undergo SR-Bx. If SR-Bx doesn't reveal clinically significant cancer, then MRI will be done in 3 months, and if lesion is present (PIRADS ≥ 3) schedule for MRUS-Bx. If there is no lesion, then no biopsy. Schedule MRI in 12 months after the initial MRI. Receives: Procedure: Biopsy of Prostate; Other: Laboratory Biomarker Analysis; Diagnostic Test: Magnetic Resonance Imaging; Diagnostic Test: MRI Ultrasound Fusion Guided Biopsy |
| Arm II (MRI, MRUS-Bx, SR-Bx) | Experimental | Patients undergo MRI. Must be scheduled at least one day before MRUS biopsy.
* If MRI shows no lesion present (PIRADS 1-2), then no MRUS-Bx. Schedule for SR-Bx only.
* If MRI shows lesion present (PIRADS ≥ 3), perform MRUS-Bx, which will be done first and followed immediately by SR-Bx. Receives: Procedure: Biopsy of Prostate; Other: Laboratory Biomarker Analysis; Diagnostic Test: Magnetic Resonance Imaging; Diagnostic Test: MRI Ultrasound Fusion Guided Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biopsy detection rate of clinically significant prostate cancer
Will code patients as having clinically significant prostate cancer if they are diagnosed with Gleason score >= 7 or any Gleason score with core length >= 5 mm or any Gleason score that includes Gleason pattern >= 4 at initial systematic random biopsy.
Measured: Up to 5 years
Secondary outcomes (1)
Presence of any of the complications
Will be summarized in the complications checklist. Will determine any striking co-morbidities that are present post-biopsy and were absent pre-biopsy within each arm, and next determine if the prevalence of any of these identified post-biopsy morbidities differs between the two arms. For these analyses, regression methods (linear, logistic, multinomial logistic as appropriate for the "dependent" variable being analyzed) will be used. Standard descriptive methods will be used to summarize and display the results.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2017
- Study start25 Sep 2017
- Primary completion31 Dec 2026 (estimated)
- Study completion23 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Status UnknownStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Inderbir Gill, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03234556
- Sponsor's protocol ID
- 4P-16-7
- Other IDs
- NCI-2017-00890, 4P-16-7, P30CA014089, R01CA205058
- Status last verified
- Jun 2026
- First submitted
- 26 Jul 2017
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosing Clinically Significant Prostate Cancer in African American and White Men Phase II, Randomized Clinical Trial, Multi-center, MR-Guided vs. 12-core Systematic Random Biopsy, Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT03234556
- Acronym / sponsor ID
- 4P-16-7
- Conditions
- Health Status Unknown, Elevated PSA
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 288 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 25 Sep 2017 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 23 May 2028 (estimated)
- First posted
- 31 Jul 2017 (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.
This randomized phase II trial studies how well systematic random biopsy or magnetic resonance imaging (MRI)-ultrasound image (US) fusion biopsy work in diagnosing prostate cancer in patients with elevated prostate specific antigen. Systematic random biopsy and MRI-US fusion biopsy may work better in improving the accuracy of prostate cancer detection.
Detailed description
PRIMARY OBJECTIVES:
- To compare the detection of clinically significant prostate cancer (CSPCa) in Arm 1 versus Arm 2.
II. To compare between African American (AA) and white men the probability of developing CSPCa within three years of initial biopsy at the start of the study.
SECONDARY OBJECTIVES:
- To determine complications and patient morbidity associated with either systematic random prostate biopsy (SR-Bx) versus (vs) magnetic resonance imaging-ultrasound image fusion biopsy (MRUS-Bx) + SR-Bx.
TERTIARY OBJECTIVES:
- To compare Gleason score between MRUS-Bx and radical prostatectomy (RP) specimen among men who elect RP (~110 in the randomized controlled trial [RCT]).
II. To assess within Arm 1 the detection of CSPCa three months after SR-Bx among men initially diagnosed with clinically insignificant prostate cancer (CinsPCa) or no cancer.
III. To identify among men invited to participate and those actually enrolled in the RCT: determinants of study participation.
IV. To identify among men invited to participate and those actually enrolled in the RCT: determinants of treatment decision (active surveillance [AS] vs radiation vs RP) including the diagnostic method.
OUTLINE: Patients are randomized into 1 of 2 arms.
ARM I: SR-Bx group
- Patients undergo SR-Bx
- If SR-Bx doesn't reveal clinically significant cancer, then MRI in 3 months, and if lesion is present (PIRADS ≥ 3) schedule for MRUS-Bx.
- If there is no lesion, then no biopsy - schedule MRI in 12 months after the initial MRI.
ARM II: MRUS-Bx group
- Patients undergo MRI. Must be scheduled at least 1 day before MRUS Biopsy.
- MRI shows no lesion present (PIRADS 1-2): no MRUS-Bx, schedule for SR-Bx only.
- MRI lesion present (PIRADS ≥ 3): schedule for MRUS-Bx, which will be done first and followed immediately after by SR-Bx.
FOLLOW UP:
After completion of procedure, patients are followed up at 2-4 weeks, 3, 6, 9, and 12 months, and then periodically for up to 5 years.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (SR-Bx) | Active comparator | Procedure: Biopsy of Prostate, Other: Laboratory Biomarker Analysis, Diagnostic Test: Magnetic Resonance Imaging, Diagnostic Test: MRI Ultrasound Fusion Guided BiopsyPatients undergo SR-Bx. If SR-Bx doesn't reveal clinically significant cancer, then MRI will be done in 3 months, and if lesion is present (PIRADS ≥ 3) schedule for MRUS-Bx. If there is no lesion, then no biopsy. Schedule MRI in 12 months after the initial MRI. |
| Arm II (MRI, MRUS-Bx, SR-Bx) | Experimental | Procedure: Biopsy of Prostate, Other: Laboratory Biomarker Analysis, Diagnostic Test: Magnetic Resonance Imaging, Diagnostic Test: MRI Ultrasound Fusion Guided BiopsyPatients undergo MRI. Must be scheduled at least one day before MRUS biopsy. * If MRI shows no lesion present (PIRADS 1-2), then no MRUS-Bx. Schedule for SR-Bx only. * If MRI shows lesion present (PIRADS ≥ 3), perform MRUS-Bx, which will be done first and followed immediately by SR-Bx. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information
- Eastern Cooperative Oncology Group (ECOG) performance status of =< 1 within 3 months (93 days) prior to being registered for protocol
- African-American or white men (Hispanic or non-Hispanic)
- Prostate biopsy-naive or a single negative biopsy
- Having elevated prostate specific antigen (PSA) (> 2.5 ng/ml) and no palpable nodule on digital rectal exam (DRE)
Key exclusion criteria (7 listed)
- Patients who have had chemotherapy or radiotherapy within 12 months of the study for other diagnoses not related to prostate cancer
- Patients receiving any other investigational agents
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Patients with active inflammatory bowel disease
- Patients who are unable to undergo MRI
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 |
|---|---|---|
| Biopsy of ProstateAlso: Prostate Biopsy, Prostatic BiopsyUndergo SR-Bx | Procedure or surgery | Arm I (SR-Bx), Arm II (MRI, MRUS-Bx, SR-Bx) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Arm I (SR-Bx), Arm II (MRI, MRUS-Bx, SR-Bx) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI ScanUndergo MRI | Diagnostic test | Arm I (SR-Bx), Arm II (MRI, MRUS-Bx, SR-Bx) |
| MRI Ultrasound Fusion Guided BiopsyAlso: Fusion Biopsy, Fusion-Guided Biopsy, MR Fusion Biopsy, MRI-Ultrasound Fusion BiopsyUndergo MRUS-Bx | Diagnostic test | Arm I (SR-Bx), Arm II (MRI, MRUS-Bx, SR-Bx) |
Primary outcome
Biopsy detection rate of clinically significant prostate cancer
Time frame: Up to 5 years
Will code patients as having clinically significant prostate cancer if they are diagnosed with Gleason score >= 7 or any Gleason score with core length >= 5 mm or any Gleason score that includes Gleason pattern >= 4 at initial systematic random biopsy.
1 secondary outcome
Presence of any of the complications
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
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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.
Inderbir Gill principal investigator
University of Southern California
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biopsy of Prostate, Laboratory Biomarker Analysis and Magnetic Resonance Imaging in people with Health Status Unknown and Elevated PSA, run by University of Southern California at 4 sites 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 9 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Biopsy detection rate of clinically significant prostate cancer (time frame: Up to 5 years). 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 5 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.