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New treatment option for Prostate Cancer
Official title The Use of Nanoparticles to Guide the Surgical Treatment of Prostate Cancer
ClinicalTrials.gov ID: NCT04167969
What this study is testing
What is (64Cu)-NOTA-PSMAi-PEG-Cy5.5-C' dot tracer?
(64Cu)-NOTA-PSMAi-PEG-Cy5.5-C' dot tracer is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for prostate cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Primary RP + PLND
- Age ≥18 years
- Patients meeting one of the following criteria:
- Tumor clinical stage T3a or higher
- Gleason score 8-10, or
You likely can't join if
- 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...
- Weight greater than the 400-lb weight limit of the PET scanner
- Unmanageable claustrophobia
See the full eligibility criteria
- 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
- 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...
- 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)
- 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...
- Weight greater than the 400-lb weight limit of the PET scanner
- Unmanageable claustrophobia
- Inability to lie in the scanner for 30 min
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.