Prostate Cancer DiagnosisPhase 2NCT05820724
PSMA PET Scan and mpMRI for Prostate Cancer Detection
A Phase 2 study testing PSMA PET scan, No PSMA PET and 18F- DCFPyl Injection in people with Prostate Cancer Diagnosis, run by VA Greater Los Angeles Healthcare System at 1 site in United States.
Trial summary
Prospective, randomized, phase 2 clinical trial to determine if PSMA PET imaging plus mpMRI improves detection of clinically significant prostate cancer as compared to mpMRI alone. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer Diagnosis
- What is being tested?
- PSMA PET scan, No PSMA PET and 18F- DCFPyl Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2023to 1 May 2026
- Phase
- Phase 2
- 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
- Patients with PI-RADS 4-5 lesion(s) on mpMRI and have elected to undergo a prostate biopsy
- Prostate mpMRI completed within 9 months prior to enrollment
- Patient capable of providing written informed consent
- Patient willing to be randomized to prostate mpMRI only vs prostate mpMRI + DCFPyL PET/CT
Who cannot join
- Less than 18 years-old at the time of radiotracer administration
- Medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study procedures or compliance.
- Creatinine clearance exceeding institutional requirements for prostate mpMRI
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Greater Los Angeles Healthcare System
Los Angeles, California, 90045
William Aronson, MD
About this study
Official title: Prostate Specific Membrane Antigen (PSMA) Scan and Multiparametric MRI for Prostate Biopsy Detection of Clinically Significant Prostate Cancer
Prospective, randomized, phase 2 clinical trial to determine if PSMA PET imaging plus mpMRI improves detection of clinically significant prostate cancer as compared to mpMRI alone.
Read the detailed description
This a prospective, randomized, phase 2 clinical trial. We will enroll patients who underwent mpMRI of the prostate as part of their standard clinical care, have PI-RADS 4, or 5 lesion(s) on mpMRI, and are scheduled to undergo fusion guided prostate biopsy. Subjects that sign the consent form will be randomized to undergo DCFPyL PET/CT imaging or no PSMA PET imaging prior to the prostate biopsy. In the PSMA scan cohort, decision for biopsy targets will be made based on the combination of the findings of mpMRI and PSMA scans. In the no PSMA scan (control) group, the biopsy will be performed based on mpMRI findings. Each patient will undergo 12 core systematic biopsy as the standard of care. Two additional biopsies for each mpMRI and PSMA PET and overlap lesion will also performed.
- Conditions
- Prostate Cancer Diagnosis
- Being tested
- PSMA PET scan, No PSMA PET, 18F- DCFPyl Injection
- Keywords
- psma PETCT, prostate mpMRI, prostate needle biopsy, DCFPyL PET/CT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSMA PET scanDiagnostic test
Also called DCFPyL PET/CT imaging
Subjects will undergo DCFPyL PET/CT imaging and mpMRI imaging prior to the prostate biopsy. The decision for biopsy targets will be made based on the combination of the findings of mpMRI and PSMA scans. The intervention includes a mpMRI, a PSMA PET scan, and a prostate biopsy.
No PSMA PETOther
Subjects will undergo mpMRI imaging prior to the prostate biopsy. These subjects do not undergo a PSMA PET scan prior to the prostate biopsy. The decision for biopsy targets will be made based on the findings of mpMRI. The intervention includes a mpMRI and a prostate biopsy.
18F- DCFPyl InjectionDrug
Also called DCFPyl
DCFPyL is a PSMA imaging ligand that was developed to enhance the detection of small lesions in the prostate or other pelvic areas. 18F- DCFPyl Injection will be administered prior to the PSMA PET/CT via an in-dwelling catheter placed in an antecubital vein or an equivalent venous access under the direct supervision of study personnel.
| Study group | Role | What they receive |
|---|---|---|
| PSMA PET+mpMRI | Experimental | PSMA PET+mpMRI guided prostate biopsy Receives: Diagnostic Test: PSMA PET scan; Drug: 18F- DCFPyl Injection |
| mpMRI only | Active comparator | mpMRI only guided prostate biopsy Receives: Other: No PSMA PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of Clinically Significant Prostate Cancer
Percentage of mpMRI and PSMA PET lesions positive for clinically significant prostate cancer
Measured: 12 weeks
Secondary outcomes (5)
Detection of Clinically Insignificant Prostate Cancer
Percentage of mpMRI and PSMA PET lesions positive for clinically insignificant prostate cancer.
Measured: 12 weeks
Difference in PSMA PET and mpMRI Clinically Significant Cancer Detection
Percentage of PSMA PET only (mpMRI negative) and PSMA PET overlapping with mpMRI lesions positive for clinically significant prostate cancer.
Measured: 12 weeks
Correlation of PSMA PET intensity with Clinically Significant Prostate Cancer
Correlate intensity of PSMA PET lesions with clinically significant prostate cancer.
Measured: 12 weeks
Correlation of AI Measures with Aggressiveness of Prostate Cancer
Correlate artificial intelligence measurement(s) (miPSMA index) of PSMA lesion(s) with aggressiveness of prostate cancer
Measured: 12 weeks
Adverse Events Associated with 18F- DCFPyl
Safety - Patients will be monitored for adverse events during injection and for two hours after radiotracer administration.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start1 May 2023 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer DiagnosisStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Greater Los Angeles Healthcare System
- Sponsor type
- US federal agency
- Collaborators
- Lantheus Medical Imaging
- Responsible party
- Sponsor
- Investigators
- William Aronson, MD, Principal investigator, VA Greater Los Angeles Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05820724
- Sponsor's protocol ID
- 1685514-1
- Status last verified
- Apr 2023
- First submitted
- 6 Apr 2023
- Last updated
- 24 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostate Specific Membrane Antigen (PSMA) Scan and Multiparametric MRI for Prostate Biopsy Detection of Clinically Significant Prostate Cancer
- ClinicalTrials.gov ID
- NCT05820724
- Acronym / sponsor ID
- 1685514-1
- Conditions
- Prostate Cancer Diagnosis
- Keywords
- psma PETCT, prostate mpMRI, prostate needle biopsy, DCFPyL PET/CT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- VA Greater Los Angeles Healthcare SystemUS federal agency
- Collaborators
- Lantheus Medical Imaging
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 20 Apr 2023 (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.
Prospective, randomized, phase 2 clinical trial to determine if PSMA PET imaging plus mpMRI improves detection of clinically significant prostate cancer as compared to mpMRI alone.
Detailed description
This a prospective, randomized, phase 2 clinical trial. We will enroll patients who underwent mpMRI of the prostate as part of their standard clinical care, have PI-RADS 4, or 5 lesion(s) on mpMRI, and are scheduled to undergo fusion guided prostate biopsy. Subjects that sign the consent form will be randomized to undergo DCFPyL PET/CT imaging or no PSMA PET imaging prior to the prostate biopsy. In the PSMA scan cohort, decision for biopsy targets will be made based on the combination of the findings of mpMRI and PSMA scans. In the no PSMA scan (control) group, the biopsy will be performed based on mpMRI findings. Each patient will undergo 12 core systematic biopsy as the standard of care. Two additional biopsies for each mpMRI and PSMA PET and overlap lesion will also performed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PSMA PET+mpMRI | Experimental | Diagnostic Test: PSMA PET scan, Drug: 18F- DCFPyl InjectionPSMA PET+mpMRI guided prostate biopsy |
| mpMRI only | Active comparator | Other: No PSMA PETmpMRI only guided prostate biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with PI-RADS 4-5 lesion(s) on mpMRI and have elected to undergo a prostate biopsy
- Prostate mpMRI completed within 9 months prior to enrollment
- Patient capable of providing written informed consent
- Patient willing to be randomized to prostate mpMRI only vs prostate mpMRI + DCFPyL PET/CT
Key exclusion criteria (3 listed)
- Less than 18 years-old at the time of radiotracer administration
- Medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study procedures or compliance.
- Creatinine clearance exceeding institutional requirements for prostate mpMRI
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 |
|---|---|---|
| PSMA PET scanAlso: DCFPyL PET/CT imagingSubjects will undergo DCFPyL PET/CT imaging and mpMRI imaging prior to the prostate biopsy. The decision for biopsy targets will be made based on the combination of the findings of mpMRI and PSMA scans. The intervention includes a mpMRI, a PSMA PET scan, and a prostate biopsy. | Diagnostic test | PSMA PET+mpMRI |
| No PSMA PETSubjects will undergo mpMRI imaging prior to the prostate biopsy. These subjects do not undergo a PSMA PET scan prior to the prostate biopsy. The decision for biopsy targets will be made based on the findings of mpMRI. The intervention includes a mpMRI and a prostate biopsy. | Other | mpMRI only |
| 18F- DCFPyl InjectionAlso: DCFPylDCFPyL is a PSMA imaging ligand that was developed to enhance the detection of small lesions in the prostate or other pelvic areas. 18F- DCFPyl Injection will be administered prior to the PSMA PET/CT via an in-dwelling catheter placed in an antecubital vein or an equivalent venous access under the direct supervision of study personnel. | Drug | PSMA PET+mpMRI |
Primary outcome
Detection of Clinically Significant Prostate Cancer
Time frame: 12 weeks
Percentage of mpMRI and PSMA PET lesions positive for clinically significant prostate cancer
5 secondary outcomes
Detection of Clinically Insignificant Prostate Cancer
Time frame: 12 weeks
Difference in PSMA PET and mpMRI Clinically Significant Cancer Detection
Time frame: 12 weeks
Correlation of PSMA PET intensity with Clinically Significant Prostate Cancer
Time frame: 12 weeks
Correlation of AI Measures with Aggressiveness of Prostate Cancer
Time frame: 12 weeks
Adverse Events Associated with 18F- DCFPyl
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
- Individual participant dataSharing planned: No
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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.
William Aronson, MD principal investigator
VA Greater Los Angeles Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PSMA PET scan, No PSMA PET and 18F- DCFPyl Injection in people with Prostate Cancer Diagnosis, run by VA Greater Los Angeles Healthcare System 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 3 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 24 Apr 2023. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 William Aronson, MD (310-268-3446, william.aronson@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of Clinically Significant Prostate Cancer (time frame: 12 weeks). 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 24 Apr 2023; AzTrials last refreshed its copy on 6 Nov 2026.