Prostate CancerNCT04030338
Prostate-Specific Membrane Antigen (PSMA) PET Scans in People Prostate Cancer
An observational study of Prostate Cancer and Prostate Neoplasm, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
The purpose of this study is to determine if Prostate-Specific Membrane Antigen (PSMA) positron emission tomography (PET) scans used in this study accurate and better at imaging participants' prostate cancer than the usual methods. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Prostate Neoplasm, Prostate Adenocarcinoma
- What is being tested?
- 18F-DCFPyL-iPSMA, 68Ga-HBED-iPSMA and PET/CT scan
- Type of treatment
- Injection or infusion
- How many people
- 58 participants
- Where
- 7 sitesUnited States
- Study dates
- 19 Jul 2019to Jul 2027
- Phase
- Observational
- 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
Study population: Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team at Memorial Sloan Kettering Cancer Center (MSK) in the Department of Medical Oncology, Radiology, Radiation Oncology or Surgery. Investigators will screen their patients' medical records for suitable research study participants and discuss the study and their potential for enrolling in the research study.
Who may be able to join
- Patients with histologically confirmed prostate cancer, that is either: newly diagnosed OR progressive as defined by standard PCWG3 criteria. note that metastatic disease is defined by either bone scintigraphy or by CT or MRI, or a combination of these tests, but not exclusively by molecular imaging criteria.
- Patients with newly diagnosed localized or metastatic prostate cancer are eligible, provided standard imaging (either bone scintigraphy, CT or MRI) demonstrates evidence of radiographic disease
- Patient with progressive disease that is non-metastatic are eligible by biochemical progression: A minimum of three rising PSA values from a baseline that are obtained 1 week or more apart, or 2 measurements 2 or more weeks apart
- Patients with progressive disease that is metastatic are eligible either by biochemical progression or radiographic progression or both
- Patients are permitted to have had up to 2 months of prior hormonal therapy before entering this trial (and many therapeutic trials) and therefore, their progression criteria would apply to their pre-treatment imaging and PSA parameters Note: This criterion pertains to patients with newly diagnosed, untreated disease. This criterion does not apply to those who were already on therapy for metastatic CRPC.
- Karnofsky performance status of >/= 50 (or ECOG/WHO equivalent)
Show all 9Show fewer
- Male (or transgender female) > 18 years of age
- Patient must be able to understand and willing to sign a written informed consent document
- Patient is anticipating starting a therapeutic strategy following imaging
Who cannot join
- Patient undergoing active treatment for non-prostate malignancy, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and non-invasive bladder cancer
- Unable to lie flat, still or tolerate a PET scan
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Commack
Commack, New York, 11725
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553
About this study
Official title: Serial PSMA PET Imaging in the Assessment of Treatment Response in Patients With Progressive Prostate Cancer
The purpose of this study is to determine if Prostate-Specific Membrane Antigen (PSMA) positron emission tomography (PET) scans used in this study accurate and better at imaging participants' prostate cancer than the usual methods.
- Conditions
- Prostate Cancer, Prostate Neoplasm, Prostate Adenocarcinoma, Prostate Cancer Metastatic, Metastatic Prostate Cancer
- Being tested
- 18F-DCFPyL-iPSMA, 68Ga-HBED-iPSMA, PET/CT scan
- Keywords
- prostate cancer, Metastatic Prostate Cancer, PCWG3, 18 F-DCFPyL, 68 Ga-PSMA, 19-170, Memorial Sloan Kettering Cancer Center
- 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-DCFPyL-iPSMADrug
Participants will be injected intravenously with a bolus of 7-10 mCi of 18F-DCFPyL.
68Ga-HBED-iPSMADrug
Participants will be injected intravenously with a bolus of 3-8 mCi of 68Ga-HBED-iPSMA
PET/CT scanDiagnostic test
The baseline PSMA PET scan may be performed externally or at MSKCC, but all follow-up imaging must be performed at MSKCC. Approximately 60-90 minutes after intravenous injection of radiotracer, patients will be scanned from the mid-skull to the mid-thigh. Imaging will start with a low-dose CT for attenuation correction, followed by a PET scan. Upon completion of imaging and at the discretion of the investigator, the patient may be asked to void and get back in the scanner for 1 additional image of the pelvis.This additional image allows investigator's to see an unobstructed view of the prostate/prostate bed
| Study group | Role | What they receive |
|---|---|---|
| Prostate cancer | Participants with histologically confirmed prostate cancer, that is either newly diagnosed OR progressive as defined by standard PCWG3 criteria. Patients w ill remain on study until 30 days after their last PSMA imaging timepoint required by their companion therapeutic protocol. Receives: Drug: 18F-DCFPyL-iPSMA; Drug: 68Ga-HBED-iPSMA; Diagnostic Test: PET/CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure predictive accuracy of the change in PSMA PET with respect to the time to biochemical progression
Measured: start of treatment to the first PSA level above 0.2 ng/ml, up to 100 months
Measure predictive accuracy of the change in PSMA PET with respect to the time to metastasis
Measured: Time from the start of treatment to evidence of systemic disease on bone scan or CT/MRI, up to 100 months
Measure predictive accuracy of the change in PSMA PET with respect to overall survival time.
Measured: Time from the start of treatment to date of death from any cause, assessed up to up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study start19 Jul 2019
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Progenics Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Heiko Schoder, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04030338
- Sponsor's protocol ID
- 19-170
- Status last verified
- Aug 2026
- First submitted
- 19 Jul 2019
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serial PSMA PET Imaging in the Assessment of Treatment Response in Patients With Progressive Prostate Cancer
- ClinicalTrials.gov ID
- NCT04030338
- Acronym / sponsor ID
- 19-170
- Conditions
- Prostate Cancer, Prostate Neoplasm, Prostate Adenocarcinoma, Prostate Cancer Metastatic, Metastatic Prostate Cancer
- Keywords
- prostate cancer, Metastatic Prostate Cancer, PCWG3, 18 F-DCFPyL, 68 Ga-PSMA, 19-170, Memorial Sloan Kettering Cancer Center
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Progenics Pharmaceuticals, Inc.
- Study start
- 19 Jul 2019 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 23 Jul 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.
The purpose of this study is to determine if Prostate-Specific Membrane Antigen (PSMA) positron emission tomography (PET) scans used in this study accurate and better at imaging participants' prostate cancer than the usual methods.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prostate cancer | – | Drug: 18F-DCFPyL-iPSMA, Drug: 68Ga-HBED-iPSMA, Diagnostic Test: PET/CT scanParticipants with histologically confirmed prostate cancer, that is either newly diagnosed OR progressive as defined by standard PCWG3 criteria. Patients w ill remain on study until 30 days after their last PSMA imaging timepoint required by their companion therapeutic protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team at Memorial Sloan Kettering Cancer Center (MSK) in the Department of Medical Oncology, Radiology, Radiation Oncology or Surgery. Investigators will screen their patients' medical records for suitable research study participants and discuss the study and their potential for enrolling in the research study.
Key inclusion criteria (9 listed)
- Patients with histologically confirmed prostate cancer, that is either: newly diagnosed OR progressive as defined by standard PCWG3 criteria. note that metastatic disease is defined by either bone scintigraphy or by CT or MRI, or a combination of these tests, but not exclusively by molecular imaging criteria.
- Patients with newly diagnosed localized or metastatic prostate cancer are eligible, provided standard imaging (either bone scintigraphy, CT or MRI) demonstrates evidence of radiographic disease
- Patient with progressive disease that is non-metastatic are eligible by biochemical progression: A minimum of three rising PSA values from a baseline that are obtained 1 week or more apart, or 2 measurements 2 or more weeks apart
- Patients with progressive disease that is metastatic are eligible either by biochemical progression or radiographic progression or both
- Patients are permitted to have had up to 2 months of prior hormonal therapy before entering this trial (and many therapeutic trials) and therefore, their progression criteria would apply to their pre-treatment imaging and PSA parameters Note: This criterion pertains to patients with newly diagnosed, untreated disease. This criterion does not apply to those who were already on therapy for metastatic CRPC.
Key exclusion criteria (2 listed)
- Patient undergoing active treatment for non-prostate malignancy, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and non-invasive bladder cancer
- Unable to lie flat, still or tolerate a PET scan
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-DCFPyL-iPSMAParticipants will be injected intravenously with a bolus of 7-10 mCi of 18F-DCFPyL. | Drug | Prostate cancer |
| 68Ga-HBED-iPSMAParticipants will be injected intravenously with a bolus of 3-8 mCi of 68Ga-HBED-iPSMA | Drug | Prostate cancer |
| PET/CT scanThe baseline PSMA PET scan may be performed externally or at MSKCC, but all follow-up imaging must be performed at MSKCC. Approximately 60-90 minutes after intravenous injection of radiotracer, patients will be scanned from the mid-skull to the mid-thigh. Imaging will start with a low-dose CT for attenuation correction, followed by a PET scan. Upon completion of imaging and at the discretion of the investigator, the patient may be asked to void and get back in the scanner for 1 additional image of the pelvis.This additional image allows investigator's to see an unobstructed view of the prostate/prostate bed | Diagnostic test | Prostate cancer |
Primary outcome
Measure predictive accuracy of the change in PSMA PET with respect to the time to biochemical progression
Time frame: start of treatment to the first PSA level above 0.2 ng/ml, up to 100 months
Measure predictive accuracy of the change in PSMA PET with respect to the time to metastasis
Time frame: Time from the start of treatment to evidence of systemic disease on bone scan or CT/MRI, up to 100 months
Measure predictive accuracy of the change in PSMA PET with respect to overall survival time.
Time frame: Time from the start of treatment to date of death from any cause, assessed up to up to 100 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 5 Aug 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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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.
Heiko Schoder, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Prostate Neoplasm, run by Memorial Sloan Kettering Cancer Center at 7 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 2 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 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Measure predictive accuracy of the change in PSMA PET with respect to the time to biochemical progression (time frame: start of treatment to the first PSA level above 0.2 ng/ml, up to 100 months). The study lists 3 primary outcomes in all. 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 Aug 2026.