Prostate NeoplasmNCT04124107
Unfavorable MRI But Favorable 68Ga-PSMA PET/MRI for Primary Prostate Cancer Detection
A study testing multiparametric MRI and 68Ga-PSMA PET/MRI and Prostate biopsy in people with Prostate Neoplasm, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
Trial summary
This perspective cohort study aims to assess the detection rate of prostate cancer through prostate biopsy within suspicious patients harboring unfavorable multiparametric MRI but favorable 68Ga-PSMA PET/MRI who have had no prior prostate biopsy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Neoplasm
- What is being tested?
- multiparametric MRI and 68Ga-PSMA PET/MRI and Prostate biopsy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Dec 2019to Dec 2020
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men more than 18 years old with clinical suspicion of prostate cancer;
- Serum prostate-specific antigen (PSA) > 4 ng/ml within the previous 3 months;
- PI-RADS score no more than 3 or normal mpMRI of prostate;
- Suspicious lesion(s) within prostate on 68Ga-PSMA PET/MRI;
- no evidence of PSA increase by noncancerous factors, such as catheterization, bladder stones, or urinary tract infection including bacterial prostatitis;
- Able to provide written informed consent.
Who cannot join
- Prior prostate biopsy or prostate surgery;
- Prior treatment for prostate cancer;
- Contraindication to MRI or PET (e.g. claustrophobia, pacemaker, estimated glomerular filtration rate ≤ 50mls/min);
- Contraindication to prostate biopsy.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Diagnostic Performance of 68Ga-PSMA PET/MRI in Suspicious Biopsy-naive Prostate Cancer Patients With Favorable Lesion on PET But Unfavorable on MRI for Primary Prostate Cancer Detection: a Pilot Study
This perspective cohort study aims to assess the detection rate of prostate cancer through prostate biopsy within suspicious patients harboring unfavorable multiparametric MRI but favorable 68Ga-PSMA PET/MRI who have had no prior prostate biopsy.
Read the detailed description
Multiparametric MRI (MpMRI) is currently regarded as the best imaging method to noninvasively identify and characterize prostate cancer (PCa) with the Prostate Imaging Reporting and Data System (PI-RADS) v2. However, there are diagnostic difficulties for suspicious patients with PI-RADS score 3 and not all PCa are equivalently visible on mpMRI. For such patients, other alternative imaging techniques are required to properly characterize and detect PCa.
It has been widely reported that 68Ga-PSMA PET imaging offers excellent performance in detecting primary PCa and is able to noninvasively characterize the aggressiveness of PCa. Recently, integrated PET/MRI, which combines the strengths of both modalities, has been shown to have great potential for influencing clinical practice by providing a more certain map of localized PCa to aid targeted biopsies and therapy.
This perspective cohort study aims to assess the detection rate of PCa through prostate biopsy within suspicious patients harboring unfavorable mpMRI but favorable 68Ga-PSMA PET/MRI who have had no prior prostate biopsy.
- Conditions
- Prostate Neoplasm
- Being tested
- multiparametric MRI and 68Ga-PSMA PET/MRI, 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.
multiparametric MRI and 68Ga-PSMA PET/MRIDevice
All participants will undergo multiparametric MRI examination. If mpMRI is unfavorable for prostate cancer, participants will undergo 68Ga-PSMA PET/MRI examination
Prostate biopsyProcedure or surgery
Participants with unfavorable mpMRI but favorable 68Ga-PSMA PET/MRI will undergo both 68Ga-PSMA PET/MRI-ultrasound-fusion targeted biopsy and transperineal ultrasound guided 12-core systematic biopsy
| Study group | Role | What they receive |
|---|---|---|
| Prostate biopsy with 68Ga-PSMA PET/MRI | Experimental | Both targeted biopsy and 12-core systematic biopsy with positive 68Ga-PSMA PET/MRI Receives: Device: multiparametric MRI and 68Ga-PSMA PET/MRI; Procedure: Prostate biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rate of prostate cancer
Detection rate of prostate cancer
Measured: 30 days post biopsy
Secondary outcomes (3)
Detection rates of clinically significant PCa and clinically insignificant prostate cancer
Detection rates of clinically significant PCa and clinically insignificant prostate cancer
Measured: 30 days post biopsy
Gleason grade group distribution (score from 1 to 5, the bigger the score, the worse the prognosis) and aggressive architecture (such as cribriform) on final pathology
Gleason grade group distribution (score from 1 to 5, the bigger the score, the worse the prognosis) and aggressive architecture (such as cribriform) on final pathology
Measured: 90 days post biopsy
Optimal cut-off uptake value on PET/MRI for prostate cancer detection
Optimal cut-off uptake value on PET/MRI for prostate cancer detection
Measured: 30 days post-biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2019
- Study startDec 2019 (estimated)
- Primary completionNov 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate NeoplasmStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe 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
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongqian Guo, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Investigators
- Hongqian Guo, PhD, Study chair, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04124107
- Sponsor's protocol ID
- PET+/MRI- v1.0 20191010
- Status last verified
- Oct 2019
- First submitted
- 10 Oct 2019
- Last updated
- 14 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance of 68Ga-PSMA PET/MRI in Suspicious Biopsy-naive Prostate Cancer Patients With Favorable Lesion on PET But Unfavorable on MRI for Primary Prostate Cancer Detection: a Pilot Study
- ClinicalTrials.gov ID
- NCT04124107
- Acronym / sponsor ID
- PET+/MRI- v1.0 20191010
- Conditions
- Prostate Neoplasm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- Dec 2019 (estimated)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 11 Oct 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.
This perspective cohort study aims to assess the detection rate of prostate cancer through prostate biopsy within suspicious patients harboring unfavorable multiparametric MRI but favorable 68Ga-PSMA PET/MRI who have had no prior prostate biopsy.
Detailed description
Multiparametric MRI (MpMRI) is currently regarded as the best imaging method to noninvasively identify and characterize prostate cancer (PCa) with the Prostate Imaging Reporting and Data System (PI-RADS) v2. However, there are diagnostic difficulties for suspicious patients with PI-RADS score 3 and not all PCa are equivalently visible on mpMRI. For such patients, other alternative imaging techniques are required to properly characterize and detect PCa.
It has been widely reported that 68Ga-PSMA PET imaging offers excellent performance in detecting primary PCa and is able to noninvasively characterize the aggressiveness of PCa. Recently, integrated PET/MRI, which combines the strengths of both modalities, has been shown to have great potential for influencing clinical practice by providing a more certain map of localized PCa to aid targeted biopsies and therapy.
This perspective cohort study aims to assess the detection rate of PCa through prostate biopsy within suspicious patients harboring unfavorable mpMRI but favorable 68Ga-PSMA PET/MRI who have had no prior prostate biopsy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prostate biopsy with 68Ga-PSMA PET/MRI | Experimental | Device: multiparametric MRI and 68Ga-PSMA PET/MRI, Procedure: Prostate biopsyBoth targeted biopsy and 12-core systematic biopsy with positive 68Ga-PSMA PET/MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men more than 18 years old with clinical suspicion of prostate cancer;
- Serum prostate-specific antigen (PSA) > 4 ng/ml within the previous 3 months;
- PI-RADS score no more than 3 or normal mpMRI of prostate;
- Suspicious lesion(s) within prostate on 68Ga-PSMA PET/MRI;
- no evidence of PSA increase by noncancerous factors, such as catheterization, bladder stones, or urinary tract infection including bacterial prostatitis;
Key exclusion criteria (4 listed)
- Prior prostate biopsy or prostate surgery;
- Prior treatment for prostate cancer;
- Contraindication to MRI or PET (e.g. claustrophobia, pacemaker, estimated glomerular filtration rate ≤ 50mls/min);
- Contraindication to prostate biopsy.
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 |
|---|---|---|
| multiparametric MRI and 68Ga-PSMA PET/MRIAll participants will undergo multiparametric MRI examination. If mpMRI is unfavorable for prostate cancer, participants will undergo 68Ga-PSMA PET/MRI examination | Device | Prostate biopsy with 68Ga-PSMA PET/MRI |
| Prostate biopsyParticipants with unfavorable mpMRI but favorable 68Ga-PSMA PET/MRI will undergo both 68Ga-PSMA PET/MRI-ultrasound-fusion targeted biopsy and transperineal ultrasound guided 12-core systematic biopsy | Procedure or surgery | Prostate biopsy with 68Ga-PSMA PET/MRI |
Primary outcome
Detection rate of prostate cancer
Time frame: 30 days post biopsy
Detection rate of prostate cancer
3 secondary outcomes
Detection rates of clinically significant PCa and clinically insignificant prostate cancer
Time frame: 30 days post biopsy
Gleason grade group distribution (score from 1 to 5, the bigger the score, the worse the prognosis) and aggressive architecture (such as cribriform) on final pathology
Time frame: 90 days post biopsy
Optimal cut-off uptake value on PET/MRI for prostate cancer detection
Time frame: 30 days post-biopsy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2019.
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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.
Hongqian Guo, PhD study chair
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Questions about this trial
What is this clinical trial studying?
A study testing multiparametric MRI and 68Ga-PSMA PET/MRI and Prostate biopsy in people with Prostate Neoplasm, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 14 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongqian Guo, PhD (8613605171690 ext. 8613605171690, dr.ghq@nju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection rate of prostate cancer (time frame: 30 days post biopsy). 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 14 Oct 2019.