Metastatic Prostate CancerPhase 2NCT03173924
18F-DCFPyL PSMA- Versus 18F-NaF-PET Imaging for Detection of Metastatic Prostate Cancer
A Phase 2 study testing 18F-NaF, 18F-DCFPyL and 18F-FDG in people with Metastatic Prostate Cancer and Prostatic Neoplasms, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: Prostate cancer is the second leading cause of cancer deaths in American men. Few options exist to create images of this type of cancer. Researchers think an experimental radiotracer called 18F-DCFPyL could find sites of cancer in the body. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Prostate Cancer, Prostatic Neoplasms, Prostate Cancer
- What is being tested?
- 18F-NaF, 18F-DCFPyL and 18F-FDG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2017to 6 Feb 2028
- Phase
- Phase 2
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 18 years old
- Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2.
- Ability of subject to understand and the willingness to sign a written informed consent document.
- Patients must have confirmation of prostate cancer with identifiable metastatic disease on at least 1 clinically indicated imaging modality. If there is only soft tissue metastasis, one lesion must measure at least 6 mm or greater. OR Documented history of metastatic prostate cancer.
- Patients must be co-enrolled on a UOB, GMB or ROB protocol
- Histological confirmation of prostate cancer
- Patients must be willing to undergo mandatory research biopsy
Who cannot join
- Subjects for whom participating would significantly delay the scheduled standard of care therapy.
- Subjects with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results.
- Subjects with severe claustrophobia unresponsive to oral anxiolytics
- Other medical conditions deemed by the principal investigator (or associates) to make the subject unsafe/ineligible for protocol procedures.
- Subjects weighing greater than 350 lbs. (weight limit for scanner table), or unable to fit within the imaging gantry
- Serum creatinine greater than 2 times the upper limit of normal
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Evaluation of 18F-DCFPyL PSMA- Versus 18F-NaF-PET Imaging for Detection of Metastatic Prostate Cancer
Background:
Prostate cancer is the second leading cause of cancer deaths in American men. Few options exist to create images of this type of cancer. Researchers think an experimental radiotracer called 18F-DCFPyL could find sites of cancer in the body.
Read more
Objective:
To see if 18F-DCFPyL can identify sites of prostate cancer in people with the disease.
Eligibility:
People ages 18 and older who have metastatic prostate cancer
Design:
Participants will be screened with:
- Blood tests
- Physical exam
- Medical history
Participants will be assigned to 1 of 2 groups based on their PSA.
Participants will have 18F-DCFPyL injected into a vein. About 2 hours later they will have a whole-body Positron Emission
Tomography/Computed Tomography (PET/CT). For the scan, they will lie on their back on the scanner table while it takes pictures of the body. This lasts about 50 minutes.
On another day, participants will have 18F -NaF injected into a vein. About 1 hour later, they will have a whole-body PET/CT.
Participants will be contacted 1 3 days later for follow-up. They may undergo PET/Magnetic Resonance Imaging (MRI) either after having a 18F-DCFPyL PET/CT, or in place of PET/CT imaging. A tube may be placed in the rectum. More coils may be wrapped around the outside of the pelvis.
If the 18F-DCFPyL PET/CT is positive participants will be encouraged to undergo a biopsy of one of the tumors. The biopsy will be taken through a needle put through the skin into the tumor.
Participants will be followed for 1 year. During this time researchers will collect information about their prostate cancer, such as PSA levels and biopsy results.
About 4-6 months after scanning is completed, participants may have a tumor biopsy. The biopsy will be taken through a needle put through the skin into the tumor.
...
Read the detailed description
Background:
The objective of this study is to evaluate a radiolabeled urea-based small molecule inhibitor of prostate-specific membrane antigen (PSMA), [18F] DCFPyL (DCFPyL) PET/CT (or PET/MRI imaging if available) for detection of metastatic prostate cancer
PSMA is a well characterized histological marker of prostate cancer tumor aggressiveness and metastatic potential
Our preliminary first-in-human studies demonstrate high specific uptake of a first generation less avid compound, DCFBC, in metastatic prostate cancer and demonstrated feasibility for prostate cancer metastatic detection.
We propose to assess the ability of DCFPyL PET to detect metastatic prostate cancer by visual qualitative and quantitative SUV analysis. Correlation will be made to sites of suspected bony metastatic disease detected by ultra-sensitive but less specific [18F] Sodium Fluoride (NaF)-PET/CT imaging and all sites of suspected disease detected by [18F] Fluorodeoxyglucose (FDG) for prostate cancer.
Objective:
To compare the diagnostic sensitivity of DCFPyL-PET/CT (or PET/MRI imaging if available) to NaF-PET/CT for detection of prostate cancer bone metastasis based on comparison to reference standard of care conventional imaging modalities (CIM); such as CT and whole body bone scintigraphy incorporating prior and follow-up scans and histopathology when available.
Eligibility:
Histological confirmation of prostate cancer
Age >=18 years old
Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2.
Patients must have either:
- Confirmation of prostate cancer with identifiable metastatic disease on at least 1 clinically indicated imaging modality. If there is only soft tissue metastasis, one lesion must measure at least 6 mm or greater. OR
- Documented history of metastatic prostate cancer.
Design:
Two Cohort study
Cohort 1: Stable/Decreasing Prostate Specific Antigen (PSA): PSA must be equal to or less than 0.5 ng/mL value of the last PSA obtained (at least one month apart)
Cohort 2: Rising PSA: PSA must be greater than 0.5 ng/mL above the last PSA value obtained on at least two occasions within 1 year
Patients will undergo DCFPyL PET/CT (or PET/MRI), NaF-PET/CT, and FDG PET/CT within 21 days of each other. The order obtained does not matter.
The DCFPyL PET/CT (or PET/MRI) will be compared with the NaF-PET/CT and FDG PET/CT and standard chest/abdomen/pelvis CT.
DCFPyL PET/CT (or PET/MRI) detection of metastatic disease will be assessed by visual qualitative assessment as positive, equivocal, or negative. Sites of equivocal or positive metastatic disease will have a quantitative PET assessment (SUVmax, SUVmean).
A mandatory research biopsy will be performed under image guidance on a suspicious lesion, if feasible.
The patients will be followed yearly for 4 years by chart review, phone-call, email or any other NIH approved platform for PSA relapse and radiologic evidence of metastatic disease. Additional 18F-DCFPyL and 18F-FDG PET/CTs might be performed during the subject s follow up period there has been a considerable change in patient status (progression or response) based on PSA value, symptomatology, bone scan or CT findings.
- Conditions
- Metastatic Prostate Cancer, Prostatic Neoplasms, Prostate Cancer, Prostatic Cancer, Prostate Neoplasms
- Being tested
- 18F-NaF, 18F-DCFPyL, 18F-FDG
- Keywords
- Small Molecule, Radiolabeled, PSA, Diagnostic, PMSA
- Medical subject headings
- Prostatic Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-NaFDrug
Baseline IV followed by PET/CT IMAGING
18F-DCFPyLDrug
Baseline IV followed by PET/CT IMAGING. Additional 18F-DCFPyL PET/CTs might be performed during the subject s follow up period if, in the opinion of the referring clinician, there has been a considerable change in patient status (progression or response) based on clinical grounds/PSA value or to help assess changes of standard of care therapy.
18F-FDGDrug
Baseline IV followed by PET/CT IMAGING. Additional 18F-FDG PET/CTs may be obtained per PI discretion within a 21-day window relative to each 18F-DCFPyL PET/CTs.
| Study group | Role | What they receive |
|---|---|---|
| 1/Experimental intervention | Experimental | 18F-DCFPyL is administered to cohorts Receives: Drug: 18F-NaF; Drug: 18F-DCFPyL; Drug: 18F-FDG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of DCFPyL-PET/CT diagnostics
Accuracy of DCFPyL-PET/CT diagnostics
Measured: 36 months
Secondary outcomes (2)
PSMA expression in lesion samples from patients with presumed stable disease and actively expanding disease
Correlation between PSMA expression and PSA levels
Measured: 36 months
Association between PSA parameters and the number of metastases identified with DCFPyL- PET/CT (or PET/MRI imaging if available).
Correlation between PSA parameters and the number of metastases identified with DCFPyL- PET/CT
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2017
- Study start6 Jun 2017
- Primary completion6 Feb 2028 (estimated)
- Study completion6 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Metastatic Prostate CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Peter L Choyke, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03173924
- Sponsor's protocol ID
- 170089
- Other IDs
- 17-C-0089
- Status last verified
- 13 Oct 2026
- First submitted
- 31 May 2017
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.
Publications
Szabo Z, Mena E, Rowe SP, Plyku D, Nidal R, Eisenberger MA, Antonarakis ES, Fan H, Dannals RF, Chen Y, Mease RC, Vranesic M, Bhatnagar A, Sgouros G, Cho SY, Pomper MG. Initial Evaluation of [(18)F]DCFPyL for Prostate-Specific Membrane Antigen (PSMA)-Targeted PET Imaging of Prostate Cancer. Mol Imaging Biol. 2015 Aug;17(4):565-74. doi: 10.1007/s11307-015-0850-8.
PubMed 25896814Cho SY, Gage KL, Mease RC, Senthamizhchelvan S, Holt DP, Jeffrey-Kwanisai A, Endres CJ, Dannals RF, Sgouros G, Lodge M, Eisenberger MA, Rodriguez R, Carducci MA, Rojas C, Slusher BS, Kozikowski AP, Pomper MG. Biodistribution, tumor detection, and radiation dosimetry of 18F-DCFBC, a low-molecular-weight inhibitor of prostate-specific membrane antigen, in patients with metastatic prostate cancer. J Nucl Med. 2012 Dec;53(12):1883-91. doi: 10.2967/jnumed.112.104661.
PubMed 23203246Chen Y, Pullambhatla M, Foss CA, Byun Y, Nimmagadda S, Senthamizhchelvan S, Sgouros G, Mease RC, Pomper MG. 2-(3-1-Carboxy-5-[(6-[18F]fluoro-pyridine-3-carbonyl)-amino]-pentyl-ureido)-pentanedioic acid, [18F]DCFPyL, a PSMA-based PET imaging agent for prostate cancer. Clin Cancer Res. 2011 Dec 15;17(24):7645-53. doi: 10.1158/1078-0432.CCR-11-1357. Epub 2011 Oct 31.
PubMed 22042970
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of 18F-DCFPyL PSMA- Versus 18F-NaF-PET Imaging for Detection of Metastatic Prostate Cancer
- ClinicalTrials.gov ID
- NCT03173924
- Acronym / sponsor ID
- 170089
- Conditions
- Metastatic Prostate Cancer, Prostatic Neoplasms, Prostate Cancer, Prostatic Cancer, Prostate Neoplasms
- Keywords
- Small Molecule, Radiolabeled, PSA, Diagnostic, PMSA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 96 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 6 Jun 2017 (actual)
- Primary completion
- 6 Feb 2028 (estimated)
- Study completion
- 6 Feb 2028 (estimated)
- First posted
- 2 Jun 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.
Background:
Prostate cancer is the second leading cause of cancer deaths in American men. Few options exist to create images of this type of cancer. Researchers think an experimental radiotracer called 18F-DCFPyL could find sites of cancer in the body.
Objective:
To see if 18F-DCFPyL can identify sites of prostate cancer in people with the disease.
Eligibility:
People ages 18 and older who have metastatic prostate cancer
Design:
Participants will be screened with:
- Blood tests
- Physical exam
- Medical history
Participants will be assigned to 1 of 2 groups based on their PSA.
Participants will have 18F-DCFPyL injected into a vein. About 2 hours later they will have a whole-body Positron Emission
Tomography/Computed Tomography (PET/CT). For the scan, they will lie on their back on the scanner table while it takes pictures of the body. This lasts about 50 minutes.
On another day, participants will have 18F -NaF injected into a vein. About 1 hour later, they will have a whole-body PET/CT.
Participants will be contacted 1 3 days later for follow-up. They may undergo PET/Magnetic Resonance Imaging (MRI) either after having a 18F-DCFPyL PET/CT, or in place of PET/CT imaging. A tube may be placed in the rectum. More coils may be wrapped around the outside of the pelvis.
If the 18F-DCFPyL PET/CT is positive participants will be encouraged to undergo a biopsy of one of the tumors. The biopsy will be taken through a needle put through the skin into the tumor.
Participants will be followed for 1 year. During this time researchers will collect information about their prostate cancer, such as PSA levels and biopsy results.
About 4-6 months after scanning is completed, participants may have a tumor biopsy. The biopsy will be taken through a needle put through the skin into the tumor.
...
Detailed description
Background:
The objective of this study is to evaluate a radiolabeled urea-based small molecule inhibitor of prostate-specific membrane antigen (PSMA), [18F] DCFPyL (DCFPyL) PET/CT (or PET/MRI imaging if available) for detection of metastatic prostate cancer
PSMA is a well characterized histological marker of prostate cancer tumor aggressiveness and metastatic potential
Our preliminary first-in-human studies demonstrate high specific uptake of a first generation less avid compound, DCFBC, in metastatic prostate cancer and demonstrated feasibility for prostate cancer metastatic detection.
We propose to assess the ability of DCFPyL PET to detect metastatic prostate cancer by visual qualitative and quantitative SUV analysis. Correlation will be made to sites of suspected bony metastatic disease detected by ultra-sensitive but less specific [18F] Sodium Fluoride (NaF)-PET/CT imaging and all sites of suspected disease detected by [18F] Fluorodeoxyglucose (FDG) for prostate cancer.
Objective:
To compare the diagnostic sensitivity of DCFPyL-PET/CT (or PET/MRI imaging if available) to NaF-PET/CT for detection of prostate cancer bone metastasis based on comparison to reference standard of care conventional imaging modalities (CIM); such as CT and whole body bone scintigraphy incorporating prior and follow-up scans and histopathology when available.
Eligibility:
Histological confirmation of prostate cancer
Age >=18 years old
Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2.
Patients must have either:
- Confirmation of prostate cancer with identifiable metastatic disease on at least 1 clinically indicated imaging modality. If there is only soft tissue metastasis, one lesion must measure at least 6 mm or greater. OR
- Documented history of metastatic prostate cancer.
Design:
Two Cohort study
Cohort 1: Stable/Decreasing Prostate Specific Antigen (PSA): PSA must be equal to or less than 0.5 ng/mL value of the last PSA obtained (at least one month apart)
Cohort 2: Rising PSA: PSA must be greater than 0.5 ng/mL above the last PSA value obtained on at least two occasions within 1 year
Patients will undergo DCFPyL PET/CT (or PET/MRI), NaF-PET/CT, and FDG PET/CT within 21 days of each other. The order obtained does not matter.
The DCFPyL PET/CT (or PET/MRI) will be compared with the NaF-PET/CT and FDG PET/CT and standard chest/abdomen/pelvis CT.
DCFPyL PET/CT (or PET/MRI) detection of metastatic disease will be assessed by visual qualitative assessment as positive, equivocal, or negative. Sites of equivocal or positive metastatic disease will have a quantitative PET assessment (SUVmax, SUVmean).
A mandatory research biopsy will be performed under image guidance on a suspicious lesion, if feasible.
The patients will be followed yearly for 4 years by chart review, phone-call, email or any other NIH approved platform for PSA relapse and radiologic evidence of metastatic disease. Additional 18F-DCFPyL and 18F-FDG PET/CTs might be performed during the subject s follow up period there has been a considerable change in patient status (progression or response) based on PSA value, symptomatology, bone scan or CT findings.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1/Experimental intervention | Experimental | Drug: 18F-NaF, Drug: 18F-DCFPyL, Drug: 18F-FDG18F-DCFPyL is administered to cohorts |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age greater than or equal to 18 years old
- Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2.
- Ability of subject to understand and the willingness to sign a written informed consent document.
- Patients must have confirmation of prostate cancer with identifiable metastatic disease on at least 1 clinically indicated imaging modality. If there is only soft tissue metastasis, one lesion must measure at least 6 mm or greater. OR Documented history of metastatic prostate cancer.
- Patients must be co-enrolled on a UOB, GMB or ROB protocol
Key exclusion criteria (6 listed)
- Subjects for whom participating would significantly delay the scheduled standard of care therapy.
- Subjects with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results.
- Subjects with severe claustrophobia unresponsive to oral anxiolytics
- Other medical conditions deemed by the principal investigator (or associates) to make the subject unsafe/ineligible for protocol procedures.
- Subjects weighing greater than 350 lbs. (weight limit for scanner table), or unable to fit within the imaging gantry
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 |
|---|---|---|
| 18F-NaFBaseline IV followed by PET/CT IMAGING | Drug | 1/Experimental intervention |
| 18F-DCFPyLBaseline IV followed by PET/CT IMAGING. Additional 18F-DCFPyL PET/CTs might be performed during the subject s follow up period if, in the opinion of the referring clinician, there has been a considerable change in patient status (progression or response) based on clinical grounds/PSA value or to help assess changes of standard of care therapy. | Drug | 1/Experimental intervention |
| 18F-FDGBaseline IV followed by PET/CT IMAGING. Additional 18F-FDG PET/CTs may be obtained per PI discretion within a 21-day window relative to each 18F-DCFPyL PET/CTs. | Drug | 1/Experimental intervention |
Primary outcome
Accuracy of DCFPyL-PET/CT diagnostics
Time frame: 36 months
Accuracy of DCFPyL-PET/CT diagnostics
2 secondary outcomes
PSMA expression in lesion samples from patients with presumed stable disease and actively expanding disease
Time frame: 36 months
Association between PSA parameters and the number of metastases identified with DCFPyL- PET/CT (or PET/MRI imaging if available).
Time frame: 36 months
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 16 Oct 2026.
- Background: PubMed 25896814Szabo Z, Mena E, Rowe SP, Plyku D, Nidal R, Eisenberger MA, Antonarakis ES, Fan H, Dannals RF, Chen Y, Mease RC, Vranesic M, Bhatnagar A, Sgouros G, Cho SY, Pomper MG. Initial Evaluation of [(18)F]DCFPyL for Prostate-Specific Membrane Antigen (PSMA)-Targeted PET Imaging of Prostate Cancer. Mol Imaging Biol. 2015 Aug;17(4):565-74. doi: 10.1007/s11307-015-0850-8.
- Background: PubMed 23203246Cho SY, Gage KL, Mease RC, Senthamizhchelvan S, Holt DP, Jeffrey-Kwanisai A, Endres CJ, Dannals RF, Sgouros G, Lodge M, Eisenberger MA, Rodriguez R, Carducci MA, Rojas C, Slusher BS, Kozikowski AP, Pomper MG. Biodistribution, tumor detection, and radiation dosimetry of 18F-DCFBC, a low-molecular-weight inhibitor of prostate-specific membrane antigen, in patients with metastatic prostate cancer. J Nucl Med. 2012 Dec;53(12):1883-91. doi: 10.2967/jnumed.112.104661.
- Background: PubMed 22042970Chen Y, Pullambhatla M, Foss CA, Byun Y, Nimmagadda S, Senthamizhchelvan S, Sgouros G, Mease RC, Pomper MG. 2-(3-1-Carboxy-5-[(6-[18F]fluoro-pyridine-3-carbonyl)-amino]-pentyl-ureido)-pentanedioic acid, [18F]DCFPyL, a PSMA-based PET imaging agent for prostate cancer. Clin Cancer Res. 2011 Dec 15;17(24):7645-53. doi: 10.1158/1078-0432.CCR-11-1357. Epub 2011 Oct 31.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.
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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.
Peter L Choyke, M.D. principal investigator
National Cancer Institute (NCI)
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 18F-NaF, 18F-DCFPyL and 18F-FDG in people with Metastatic Prostate Cancer and Prostatic Neoplasms, run by National Cancer Institute (NCI) 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: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2026. 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?
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?
Accuracy of DCFPyL-PET/CT diagnostics (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03173924, which also lists 3 linked publications.
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 16 Oct 2026.