Prostate NeoplasmsPhase 2NCT03181867
18F-DCFPyL PET/CT in High Risk and Recurrent Prostate Cancer
A Phase 2 study testing 18F-DCFPyL, 18F-FDG and PSMA-11 in people with Prostate Neoplasms and Prostatic Cancer, 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. When prostate cancer is confined to the prostate there is a high chance of cure. However, it is outside the prostate or comes back after treatment, additional therapy may be needed. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Neoplasms, Prostatic Cancer, Prostate Cancer
- What is being tested?
- 18F-DCFPyL, 18F-FDG and PSMA-11
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 385 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2017to 1 Feb 2031
- 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.
- Histologically confirmed adenocarcinoma of the prostate.
- Patients (including those receiving androgen deprivation therapy) fit criteria for one of the following categories:
- Cohort 1 known localized high risk prostate cancer (PSA >10, Gleason 8-10 or clinical stage >T2c) with evidence of disease on standard imaging, OR
Show all 9Show fewer
- Cohort 2 nonspecific or no evidence of disease on standard imaging modality AND biochemical prostate cancer relapse with a PSA greater than or equal to 0.2 ng/mL. Patients must be willing to undergo mandatory research biopsy
- Participants must be co-enrolled on a MIB, UOB, GMB or ROB protocol.
- The effects of 18F-DCFPyL on the developing human fetus are unknown. For this reason, individuals must agree to use adequate contraception with their partner (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and 2 months after 18F-DCFPyL scan. Should a partner become pregnant or suspect she is pregnant while her partner is participating in this study, she should inform the treating physician immediately.
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
Background:
Prostate cancer is the second leading cause of cancer deaths in American men. When prostate cancer is confined to the prostate there is a high chance of cure. However, it is outside the prostate or comes back after treatment, additional therapy may be needed. Current methods of imaging prostate cancer are limited. Researchers want to see if a radiotracer called 18F-DCFPyL can identify prostate cancer in patients who have a high risk of cancer spreading outside the prostate or who have signs of recurrent cancer after treatment.
Read more
Objectives:
To see if the radiotracer 18F-DCFyL can help identify prostate cancer in the body before or after therapy.
Eligibility:
Men ages 18 and older who have prostate cancer that has been newly diagnosed, or has relapsed after radiation or surgery
Design:
Participants will be divided into 2 groups.
- Group 1 will be men with cancer that has been newly diagnosed as high risk by their doctor who are scheduled to have prostate removal surgery or undergo biopsy before radiation therapy.
- Group 2 will be men who have presumed prostate cancer relapse after prostate removal surgery or radiation therapy.
Both groups will have scans taken. Participants will lie still on a table in a machine that takes pictures of their body. 18F-DCFyL will be injected by intravenous (IV) line.
Participants will be contacted for follow-up after scans.
Participants in Group 1 may have surgery to remove their prostate gland or a biopsy to remove some prostate tissue. This procedure will be standard of care and is not a part of this study. They will also have an extra MRI scan of their prostate. For this, a tube, called an endorectal coil, will be placed in their rectum. Other tubes may be wrapped around the inside of their pelvis. A contrast agent will be given by IV.
Participants in Group 2 may also undergo an MRI of the pelvis and may have a biopsy of abnormalities found on the 18F-DCFyL scan.
Participants will have data about their prostate cancer collected for up to 1 year.
Read the detailed description
Background:
- Prostate cancer (PCa) is the second leading cause of cancer death in American males.
- Patients with high risk but apparently localized disease are often understaged because disease beyond the prostate is not well detected and thus leads to overtreatment with prostatectomy
- Recurrence of PCa after surgery or radiation is very common and sometimes progresses to death.
- Early intervention for recurrence has been shown to be of benefit but current methods of localizing recurrence are either insensitive (CT), non-specific (MRI) or both (bone scan). Many prostate cancers express the prostate specific membrane antigen (PSMA) a transmembrane protein with NAALADase (N-acetylated-alpha-linked-acidic dipeptidase) and folate hydrolase enzymatic activity. PSMA is also expressed in angiogenesis but otherwise has limited expression in normal tissue.
- An initial test of 18F-DCFBC, a first-generation PET agent targeting PSMA, in patients with advanced local disease and biochemically recurrent prostate cancer demonstrated the potential of PET to detect sites of recurrence but it was hampered by excessive blood pool activity.
- 18F-DCFPyL, a second generation PSMA PET agent, binds with high affinity to PSMA yet clears rapidly from the blood pool and thus, whole-body PET imaging with this agent, may provide a new tool in staging high risk cancers and detecting recurrent disease.
Primary Objective:
-To assess the ability of 18F-DCFPyL to accurately stage high-risk primary prostate cancer and detect sites of recurrent prostate cancer.
Eligibility:
- Age >=18 years old
- ECOG 0-2
- Histologically confirmed adenocarcinoma of the prostate
- Patients fit criteria for one of the following categories:
- Cohort 1: known localized high risk prostate cancer (PSA >10, Gleason 8-10 or clinical stage >T2c) with evidence of disease on standard imaging or
--Cohort 2: nonspecific or no evidence of disease on standard imaging modality AND biochemical prostate cancer relapse with a PSA > 0.2 ng/ml
Design:
- This is a single site study evaluating 18F-DCFPyL high-risk primary prostate cancer and recurrent prostate cancer.
- All subjects will undergo 18F-DCFPyL injection and whole body PET/CT imaging, performed 1 hour (+/- 15 minutes) post 18F-DCFPyL injection.
- Up to 10 eligible patients in either cohort 1 or 2 will receive an additional 18F-DCFPyL PET/CT scan within 1 month of the first study immediately after unilateral salivary gland cannulation and an infusion of unlabeled DCFPyL or PSMA-11 into the cannulated gland.
- Patients from cohort 2 who have a positive 18F-DCFPyL PET/CT scan at any time may also have a one-time 18F-FDG PET/CT within 30 days of the positive 18F-DCFPyL PET/CT.
- All patients will undergo a standard of care, clinical multiparametric MRI in the NCI Molecular Imaging Clinic within 4 months of the PET scan.
- 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 might be performed during the subject s follow up period if there has been a considerable change in patient status (progression or response) based on PSA value, symptomatology, bone scan or CT findings.
- Conditions
- Prostate Neoplasms, Prostatic Cancer, Prostate Cancer, Cancer Of Prostate, Metastatic Prostate Cancer
- Being tested
- 18F-DCFPyL, 18F-FDG, PSMA-11
- Keywords
- Endorectal MRI, Imaging, PSMA
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-DCFPyLDrug
Subjects will receive IV dose of 18F-DCFPyL by bolus injection. The maximum amount of injected active drug will be less than 4.02 mcg. The target administered activity will be 8 mCi.
18F-FDGDrug
Cohort 2 may receive a one-time 18F-FDG PET/CT after a positive 18F-DCPyL PET/CT. 18F FDG PET/CT imaging may be performed per clinical standard of care. FDG is administered at a dose of 10mCi intravenously. A whole-body PET/CT will be performed beginning post 18F FDG injection.
PSMA-11Drug
For up to 10 eligible patients from either cohort 1 or 2, an optional salivary gland blocking study may be performed in which a salivary gland is cannulated and injected with unlabeled DCFPyL or PSMA-11.
| Study group | Role | What they receive |
|---|---|---|
| 1/Localized High Risk | Experimental | 18F-DCFPyL PET/CT imaging, unlabeled PSMA-11 (optional) and possible prostatectomy Receives: Drug: 18F-DCFPyL; Drug: PSMA-11 |
| 2/biochemical recurrence (bcr) | Experimental | 18F-DCFPyL PET/CT imaging, unlabeled PSMA-11 (optional) Receives: Drug: 18F-DCFPyL; Drug: 18F-FDG; Drug: PSMA-11 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the ability of 18F-DCFPyL to accurately stage high-risk primary prostate cancer and detect sites of recurrent prostate cancer
Correlation between 18F-DCFPyL scanning and accurately staging of high-risk primary prostate cancer and detection of sites of recurrent prostate cancer.
Measured: 12 months
Secondary outcomes (3)
Evaluate the distribution of 18F-DCFPyL uptake in prostate cancer patients with biochemical relapse (site of recurrence unknown) as a function of PSA value
PSA value of the distribution of 18F-DCFPyL uptake in prostate cancer patients with biochemical relapse
Measured: 12 month
Compare the distribution of 18F-DCFPyL uptake with multiparametric MRI and whole mount histopathology in patients undergoing prostatectomy
Correlation between the distribution of 18F-DCFPyL uptake and multiparametric MRI and whole mount histopathology in patients undergoing prostatectomy
Measured: 12 month
Compare focal 18F-DCFPyL uptake with focal abnormalities identified on standard of care imaging
Correlation between focal 18F-DCFPyL uptake and focal abnormalities identified on standard of care imaging
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2017
- Study start3 Aug 2017
- Primary completion1 Feb 2031 (estimated)
- Study completion1 Feb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Prostate NeoplasmsStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 385 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
- NCT03181867
- Sponsor's protocol ID
- 170109
- Other IDs
- 17-C-0109
- Status last verified
- 13 Oct 2026
- First submitted
- 8 Jun 2017
- Last updated
- 3 Nov 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
Chen 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 22042970Cho 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 23203246Szabo 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 25896814Rowe LS, Harmon S, Horn A, Shankavaram U, Roy S, Ning H, Lindenberg L, Mena E, Citrin DE, Choyke P, Turkbey B. Pattern of failure in prostate cancer previously treated with radical prostatectomy and post-operative radiotherapy: a secondary analysis of two prospective studies using novel molecular imaging techniques. Radiat Oncol. 2021 Feb 10;16(1):32. doi: 10.1186/s13014-020-01733-x.
PubMed 33568190
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 18F-DCFPyL PET/CT in High Risk and Recurrent Prostate Cancer
- ClinicalTrials.gov ID
- NCT03181867
- Acronym / sponsor ID
- 170109
- Conditions
- Prostate Neoplasms, Prostatic Cancer, Prostate Cancer, Cancer Of Prostate, Metastatic Prostate Cancer
- Keywords
- Endorectal MRI, Imaging, PSMA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 385 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 3 Aug 2017 (actual)
- Primary completion
- 1 Feb 2031 (estimated)
- Study completion
- 1 Feb 2031 (estimated)
- First posted
- 9 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. When prostate cancer is confined to the prostate there is a high chance of cure. However, it is outside the prostate or comes back after treatment, additional therapy may be needed. Current methods of imaging prostate cancer are limited. Researchers want to see if a radiotracer called 18F-DCFPyL can identify prostate cancer in patients who have a high risk of cancer spreading outside the prostate or who have signs of recurrent cancer after treatment.
Objectives:
To see if the radiotracer 18F-DCFyL can help identify prostate cancer in the body before or after therapy.
Eligibility:
Men ages 18 and older who have prostate cancer that has been newly diagnosed, or has relapsed after radiation or surgery
Design:
Participants will be divided into 2 groups.
- Group 1 will be men with cancer that has been newly diagnosed as high risk by their doctor who are scheduled to have prostate removal surgery or undergo biopsy before radiation therapy.
- Group 2 will be men who have presumed prostate cancer relapse after prostate removal surgery or radiation therapy.
Both groups will have scans taken. Participants will lie still on a table in a machine that takes pictures of their body. 18F-DCFyL will be injected by intravenous (IV) line.
Participants will be contacted for follow-up after scans.
Participants in Group 1 may have surgery to remove their prostate gland or a biopsy to remove some prostate tissue. This procedure will be standard of care and is not a part of this study. They will also have an extra MRI scan of their prostate. For this, a tube, called an endorectal coil, will be placed in their rectum. Other tubes may be wrapped around the inside of their pelvis. A contrast agent will be given by IV.
Participants in Group 2 may also undergo an MRI of the pelvis and may have a biopsy of abnormalities found on the 18F-DCFyL scan.
Participants will have data about their prostate cancer collected for up to 1 year.
Detailed description
Background:
- Prostate cancer (PCa) is the second leading cause of cancer death in American males.
- Patients with high risk but apparently localized disease are often understaged because disease beyond the prostate is not well detected and thus leads to overtreatment with prostatectomy
- Recurrence of PCa after surgery or radiation is very common and sometimes progresses to death.
- Early intervention for recurrence has been shown to be of benefit but current methods of localizing recurrence are either insensitive (CT), non-specific (MRI) or both (bone scan). Many prostate cancers express the prostate specific membrane antigen (PSMA) a transmembrane protein with NAALADase (N-acetylated-alpha-linked-acidic dipeptidase) and folate hydrolase enzymatic activity. PSMA is also expressed in angiogenesis but otherwise has limited expression in normal tissue.
- An initial test of 18F-DCFBC, a first-generation PET agent targeting PSMA, in patients with advanced local disease and biochemically recurrent prostate cancer demonstrated the potential of PET to detect sites of recurrence but it was hampered by excessive blood pool activity.
- 18F-DCFPyL, a second generation PSMA PET agent, binds with high affinity to PSMA yet clears rapidly from the blood pool and thus, whole-body PET imaging with this agent, may provide a new tool in staging high risk cancers and detecting recurrent disease.
Primary Objective:
-To assess the ability of 18F-DCFPyL to accurately stage high-risk primary prostate cancer and detect sites of recurrent prostate cancer.
Eligibility:
- Age >=18 years old
- ECOG 0-2
- Histologically confirmed adenocarcinoma of the prostate
- Patients fit criteria for one of the following categories:
- Cohort 1: known localized high risk prostate cancer (PSA >10, Gleason 8-10 or clinical stage >T2c) with evidence of disease on standard imaging or
--Cohort 2: nonspecific or no evidence of disease on standard imaging modality AND biochemical prostate cancer relapse with a PSA > 0.2 ng/ml
Design:
- This is a single site study evaluating 18F-DCFPyL high-risk primary prostate cancer and recurrent prostate cancer.
- All subjects will undergo 18F-DCFPyL injection and whole body PET/CT imaging, performed 1 hour (+/- 15 minutes) post 18F-DCFPyL injection.
- Up to 10 eligible patients in either cohort 1 or 2 will receive an additional 18F-DCFPyL PET/CT scan within 1 month of the first study immediately after unilateral salivary gland cannulation and an infusion of unlabeled DCFPyL or PSMA-11 into the cannulated gland.
- Patients from cohort 2 who have a positive 18F-DCFPyL PET/CT scan at any time may also have a one-time 18F-FDG PET/CT within 30 days of the positive 18F-DCFPyL PET/CT.
- All patients will undergo a standard of care, clinical multiparametric MRI in the NCI Molecular Imaging Clinic within 4 months of the PET scan.
- 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 might be performed during the subject s follow up period if 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1/Localized High Risk | Experimental | Drug: 18F-DCFPyL, Drug: PSMA-1118F-DCFPyL PET/CT imaging, unlabeled PSMA-11 (optional) and possible prostatectomy |
| 2/biochemical recurrence (bcr) | Experimental | Drug: 18F-DCFPyL, Drug: 18F-FDG, Drug: PSMA-1118F-DCFPyL PET/CT imaging, unlabeled PSMA-11 (optional) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 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.
- Histologically confirmed adenocarcinoma of the prostate.
- Patients (including those receiving androgen deprivation therapy) fit criteria for one of the following categories:
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-DCFPyLSubjects will receive IV dose of 18F-DCFPyL by bolus injection. The maximum amount of injected active drug will be less than 4.02 mcg. The target administered activity will be 8 mCi. | Drug | 1/Localized High Risk, 2/biochemical recurrence (bcr) |
| 18F-FDGCohort 2 may receive a one-time 18F-FDG PET/CT after a positive 18F-DCPyL PET/CT. 18F FDG PET/CT imaging may be performed per clinical standard of care. FDG is administered at a dose of 10mCi intravenously. A whole-body PET/CT will be performed beginning post 18F FDG injection. | Drug | 2/biochemical recurrence (bcr) |
| PSMA-11For up to 10 eligible patients from either cohort 1 or 2, an optional salivary gland blocking study may be performed in which a salivary gland is cannulated and injected with unlabeled DCFPyL or PSMA-11. | Drug | 1/Localized High Risk, 2/biochemical recurrence (bcr) |
Primary outcome
To assess the ability of 18F-DCFPyL to accurately stage high-risk primary prostate cancer and detect sites of recurrent prostate cancer
Time frame: 12 months
Correlation between 18F-DCFPyL scanning and accurately staging of high-risk primary prostate cancer and detection of sites of recurrent prostate cancer.
3 secondary outcomes
Evaluate the distribution of 18F-DCFPyL uptake in prostate cancer patients with biochemical relapse (site of recurrence unknown) as a function of PSA value
Time frame: 12 month
Compare the distribution of 18F-DCFPyL uptake with multiparametric MRI and whole mount histopathology in patients undergoing prostatectomy
Time frame: 12 month
Compare focal 18F-DCFPyL uptake with focal abnormalities identified on standard of care imaging
Time frame: 12 month
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 3 Nov 2026.
- 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.
- 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 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.
- Derived from this study: PubMed 33568190Rowe LS, Harmon S, Horn A, Shankavaram U, Roy S, Ning H, Lindenberg L, Mena E, Citrin DE, Choyke P, Turkbey B. Pattern of failure in prostate cancer previously treated with radical prostatectomy and post-operative radiotherapy: a secondary analysis of two prospective studies using novel molecular imaging techniques. Radiat Oncol. 2021 Feb 10;16(1):32. doi: 10.1186/s13014-020-01733-x.
- 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-DCFPyL, 18F-FDG and PSMA-11 in people with Prostate Neoplasms and Prostatic Cancer, 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 9 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 3 Nov 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?
To assess the ability of 18F-DCFPyL to accurately stage high-risk primary prostate cancer and detect sites of recurrent prostate cancer (time frame: 12 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 NCT03181867, which also lists 4 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 3 Nov 2026.