Prostate CancerPhase 1NCT04167969
The Use of Nanoparticles to Guide the Surgical Treatment of Prostate Cancer
A Phase 1 study testing (64Cu)-NOTA-PSMAi-PEG-Cy5.5-C' dot tracer, PET/MRI/fluorescence imaging and Blood and urine sampling in people with Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.
Trial summary
The purpose of this study is to see whether using the copper-64 (64Cu) or zirconium-89 (89Zr) radiolabeled PSMA-targeting C' dot tracer, termed 64Cu-NOTA-PSMAi-PEG-Cy5.5-C' dots or 89Zr-DFO-PSMAi-PEG-Cy5.5-C' dots, is a safe way to identify tumor cells before and during surgery for prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- (64Cu)-NOTA-PSMAi-PEG-Cy5.5-C' dot tracer, PET/MRI/fluorescence imaging and Blood and urine sampling
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Feb 2021to Nov 2027
- Phase
- Phase 1
- 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
- Primary RP + PLND
- Age ≥18 years
- Patients meeting one of the following criteria:
- Tumor clinical stage T3a or higher
- Gleason score 8-10, or
- PSA level > 20 ng/mL
Show all 13Show fewer
- Patients deemed fit for surgery on the basis of preoperative evaluation at the physician's discretion
- Patient is scheduled for standard of care laparoscopic radical prostatectomy (with or without robotic assistance)
- Salvage PLND
- Age ≥18 years
- Patients with presence of suspicious lymph node on CT or MRI (of a pelvic node => 10mm in short axis or a node with abnormal morphology such as roundness irregularity or loss of fatty hilum, or PSMA-avid on PSMA PET imaging
- Patients deemed fit for surgery on the basis of preoperative evaluation at the physician's discretion
- Patient is scheduled for standard of care salvage pelvic lymph node dissection (with or without robotic assistance)
Who cannot join
- Contraindications to standard-of-care MR imaging (e.g., metal implants, claustrophobia)
- Prior androgen-deprivation therapy for prostate cancer (N/A for Salvage PLND)
- Prior pelvic radiotherapy (N/A for Salvage PLND )
- Medical illness unrelated to the tumor that, in the opinion of the attending physician and principal investigator, will preclude administration of the tracer
- °This includes patients with uncontrolled infection, chronic renal insufficiency (EGFR < 60 mL/min/1.73m2), myocardial infarction within the past 6 months, unstable angina, cardiac arrhythmias other than chronic atrial fibrillation and chronic active or persistent hepatitis, or New York Heart Association Classification III or IV heart disease
- Weight greater than the 400-lb weight limit of the PET scanner
- Unmanageable claustrophobia
- Inability to lie in the scanner for 30 min
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Heiko Schoder, MD contact
United States2 sites, 2 recruiting
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Hong Truong, MD, MS, 646-422-4360
Heiko Schoder, MD, 212-639-8001
- Not yet recruiting
Weill Cornell Medicine
New York, New York, 10065
Michelle Bradbury, MD,PhD, 917-294-4585, msb2006@med.cornell.edu
About this study
Official title: Molecular Phenotyping and Image-Guided Surgical Treatment of Prostate Cancer Using Ultrasmall Silica Nanoparticles
The purpose of this study is to see whether using the copper-64 (64Cu) or zirconium-89 (89Zr) radiolabeled PSMA-targeting C' dot tracer, termed 64Cu-NOTA-PSMAi-PEG-Cy5.5-C' dots or 89Zr-DFO-PSMAi-PEG-Cy5.5-C' dots, is a safe way to identify tumor cells before and during surgery for prostate cancer. The researchers want to determine whether pre-operative PET/MRI scans and intra-operative optical imaging performed in prostate cancer patients after the injection of one of these investigational tracers more accurately localizes cancerous deposits within the surgical bed as compared with conventional imaging scans alone. The researchers will study how the tracer travels through your body and where it is distributed. This study is the first time that the tracer will be used in patients undergoing surgery for prostate cancer.
- Conditions
- Prostate Cancer
- Being tested
- (64Cu)-NOTA-PSMAi-PEG-Cy5.5-C' dot tracer, PET/MRI/fluorescence imaging, Blood and urine sampling, laparoscopic radical prostatectomy and bilateral pelvic LN dissection or a salvage lymph node dissection, 89Zr-DFO-PSMAi-PEG-Cy5.5-C' dots
- Keywords
- Molecular Phenotyping, Ultrasmall Silica Nanoparticles, PET/MRI, 64Cu-NOTA-PSMA-PEG-Cy5.5-C' dot tracer, (89Zr)-DFO-PSMAi-PEG-Cy5.5-C' dots, 19-333
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(64Cu)-NOTA-PSMAi-PEG-Cy5.5-C' dot tracerDrug
Patients will be injected with approximately 6-7 mCi (+/- 10%) of 64Cu-NOTA-PSMAi-PEG-Cy5.5-C' dots
PET/MRI/fluorescence imagingDiagnostic test
Imaging will be performed using the GE Signa PET/MRI.
Blood and urine samplingOther
Staff will perform the IV blood draws and collect urine samples
laparoscopic radical prostatectomy and bilateral pelvic LN dissection or a salvage lymph node dissectionProcedure or surgery
Surgery will be performed within 24 h of the third PET/MRI scan.
89Zr-DFO-PSMAi-PEG-Cy5.5-C' dotsDrug
Patients (up to 6) will receive an intravenous (IV) injection of approximately 5-7 mCi (+/- 10%) of PSMA-targeting C' dot tracer within 24-48 h before surgery. Patients will then undergo one preoperative PET/MR imaging
| Study group | Role | What they receive |
|---|---|---|
| Prostate cancer patients | Experimental | Patients will receive an intravenous (IV) injection of approximately 6-7 mCi (+/- 10%) of PSMA-targeting C' dot tracer up to 48 h before surgery. Patients will then undergo serial preoperative PET/MR imaging (see below) to help characterize the safety, biodistribution/pharmacokinetics, and dosimetry of this agent. To assess total radioactivity in whole blood/plasma and urine samples, as well as radioactive metabolites, blood and urine samples will be collected at approximately 30 min post-injection as well as before each imaging session. Receives: Drug: (64Cu)-NOTA-PSMAi-PEG-Cy5.5-C' dot tracer; Diagnostic Test: PET/MRI/fluorescence imaging; Other: Blood and urine sampling; Procedure: laparoscopic radical prostatectomy and bilateral pelvic LN dissection or a salvage lymph node dissection; Drug: 89Zr-DFO-PSMAi-PEG-Cy5.5-C' dots |
What is being measured
The primary outcome is the main question the study is designed to answer.
Side effects
Will be described using CTCAE version 5 criteria.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start17 Feb 2021
- Primary completionNov 2027 (estimated)
- Study completionNov 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Cornell University/Weill Cornell Medical Center, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Hong Truong, MD, MS, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04167969
- Sponsor's protocol ID
- 19-333
- Status last verified
- Jun 2026
- First submitted
- 18 Nov 2019
- Last updated
- 10 Jun 2026
- Results posted
- No
- 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 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Phenotyping and Image-Guided Surgical Treatment of Prostate Cancer Using Ultrasmall Silica Nanoparticles
- ClinicalTrials.gov ID
- NCT04167969
- Acronym / sponsor ID
- 19-333
- Conditions
- Prostate Cancer
- Keywords
- Molecular Phenotyping, Ultrasmall Silica Nanoparticles, PET/MRI, 64Cu-NOTA-PSMA-PEG-Cy5.5-C' dot tracer, (89Zr)-DFO-PSMAi-PEG-Cy5.5-C' dots, 19-333
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Cornell University/Weill Cornell Medical Center, National Cancer Institute (NCI)
- Study start
- 17 Feb 2021 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 19 Nov 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 see whether using the copper-64 (64Cu) or zirconium-89 (89Zr) radiolabeled PSMA-targeting C' dot tracer, termed 64Cu-NOTA-PSMAi-PEG-Cy5.5-C' dots or 89Zr-DFO-PSMAi-PEG-Cy5.5-C' dots, is a safe way to identify tumor cells before and during surgery for prostate cancer. The researchers want to determine whether pre-operative PET/MRI scans and intra-operative optical imaging performed in prostate cancer patients after the injection of one of these investigational tracers more accurately localizes cancerous deposits within the surgical bed as compared with conventional imaging scans alone. The researchers will study how the tracer travels through your body and where it is distributed. This study is the first time that the tracer will be used in patients undergoing surgery for prostate cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prostate cancer patients | Experimental | Drug: (64Cu)-NOTA-PSMAi-PEG-Cy5.5-C' dot tracer, Diagnostic Test: PET/MRI/fluorescence imaging, Other: Blood and urine sampling, Procedure: laparoscopic radical prostatectomy and bilateral pelvic LN dissection or a salvage lymph node dissection, Drug: 89Zr-DFO-PSMAi-PEG-Cy5.5-C' dotsPatients will receive an intravenous (IV) injection of approximately 6-7 mCi (+/- 10%) of PSMA-targeting C' dot tracer up to 48 h before surgery. Patients will then undergo serial preoperative PET/MR imaging (see below) to help characterize the safety, biodistribution/pharmacokinetics, and dosimetry of this agent. To assess total radioactivity in whole blood/plasma and urine samples, as well as radioactive metabolites, blood and urine samples will be collected at approximately 30 min post-injection as well as before each imaging session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Primary RP + PLND
- Age ≥18 years
- Patients meeting one of the following criteria:
- Patients deemed fit for surgery on the basis of preoperative evaluation at the physician's discretion
- Patient is scheduled for standard of care laparoscopic radical prostatectomy (with or without robotic assistance)
Key exclusion criteria (8 listed)
- Contraindications to standard-of-care MR imaging (e.g., metal implants, claustrophobia)
- Prior androgen-deprivation therapy for prostate cancer (N/A for Salvage PLND)
- Prior pelvic radiotherapy (N/A for Salvage PLND )
- Medical illness unrelated to the tumor that, in the opinion of the attending physician and principal investigator, will preclude administration of the tracer
- °This includes patients with uncontrolled infection, chronic renal insufficiency (EGFR < 60 mL/min/1.73m2), myocardial infarction within the past 6 months, unstable angina, cardiac arrhythmias other than chronic atrial fibrillation and chronic active or persistent hepatitis, or New York Heart Association Classification III or IV heart disease
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 |
|---|---|---|
| (64Cu)-NOTA-PSMAi-PEG-Cy5.5-C' dot tracerPatients will be injected with approximately 6-7 mCi (+/- 10%) of 64Cu-NOTA-PSMAi-PEG-Cy5.5-C' dots | Drug | Prostate cancer patients |
| PET/MRI/fluorescence imagingImaging will be performed using the GE Signa PET/MRI. | Diagnostic test | Prostate cancer patients |
| Blood and urine samplingStaff will perform the IV blood draws and collect urine samples | Other | Prostate cancer patients |
| laparoscopic radical prostatectomy and bilateral pelvic LN dissection or a salvage lymph node dissectionSurgery will be performed within 24 h of the third PET/MRI scan. | Procedure or surgery | Prostate cancer patients |
| 89Zr-DFO-PSMAi-PEG-Cy5.5-C' dotsPatients (up to 6) will receive an intravenous (IV) injection of approximately 5-7 mCi (+/- 10%) of PSMA-targeting C' dot tracer within 24-48 h before surgery. Patients will then undergo one preoperative PET/MR imaging | Drug | Prostate cancer patients |
Primary outcome
Side effects
Time frame: 1 year
Will be described using CTCAE version 5 criteria.
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 10 Jun 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.
Heiko Schoder, MD contact
Hong Truong, MD, MS principal investigator
Memorial Sloan Kettering Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing (64Cu)-NOTA-PSMAi-PEG-Cy5.5-C' dot tracer, PET/MRI/fluorescence imaging and Blood and urine sampling in people with Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 2 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 13 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Contact Hong Truong, MD, MS (646-422-4360, truongh1@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Side effects (time frame: 1 year). 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 10 Jun 2026.