The Use of Nanoparticles to Guide the Surgical Treatment of Prostate Cancer

Part of paid clinical trials in New York, New York.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT04167969
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • (64Cu)-NOTA-PSMAi-PEG-Cy5.5-C' dot tracer — DRUG
    Patients will be injected with approximately 6-7 mCi (+/- 10%) of 64Cu-NOTA-PSMAi-PEG-Cy5.5-C' dots
  • PET/MRI/fluorescence imaging — DIAGNOSTIC_TEST
    Imaging will be performed using the GE Signa PET/MRI.
  • Blood and urine sampling — OTHER
    Staff will perform the IV blood draws and collect urine samples
  • laparoscopic radical prostatectomy and bilateral pelvic LN dissection or a salvage lymph node dissection — PROCEDURE
    Surgery will be performed within 24 h of the third PET/MRI scan.
  • 89Zr-DFO-PSMAi-PEG-Cy5.5-C' dots — DRUG
    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 Details

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.

Key Dates

Start date
Feb 17, 2021
Status verified
Jun 2026
Primary completion
Nov 30, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
16 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Prostate cancer patients
    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.

Primary Outcome Measure

Side effects [ Time Frame: 1 year ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Hong Truong, MD, MS
646-422-4360
Heiko Schoder, MD
212-639-8001
Weill Cornell MedicineNew YorkNew York10065
Michelle Bradbury, MD,PhD
[email protected]
917-294-4585

Find similar trials in New York, NY

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Memorial Sloan Kettering Cancer Center· New York, NYWeill Cornell Medicine· New York, NY

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