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Evaluating Technetium-99m and Cyanine-5 PSMA Tracer-Guided Surgery for Patients with Prostate Cancer

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What is this study about?

This clinical trial is investigating the use of a combined radioactive tracer and fluorescent dye called 99mTc-hPSMA (99mTechnetium and Cyanine-5 HybriD Prostate Specific Membrane Antigen) in surgery for prostate cancer. The purpose of the study is to confirm whether this tracer is specifically taken up by prostate cancer cells, which could help surgeons better identify cancerous tissue during operations. The tracer contains two components: a radioactive part that can be detected with special scanning equipment and a fluorescent part that glows and can be seen during surgery.

Participants in this study will undergo robot-assisted laparoscopic prostatectomy (a minimally invasive surgical procedure to remove the prostate) with extended pelvic lymph node dissection (removal of lymph nodes from the pelvic area). Before surgery, patients will receive an injection of the 99mTc-hPSMA tracer. During the operation, the surgeon will use special instruments to detect both the radioactive and fluorescent signals from the tracer, which should concentrate in cancerous areas. This may help the surgeon to better identify and remove all cancer tissue while preserving healthy tissue.

The study will evaluate how well the tracer works for identifying cancer in the prostate and lymph nodes, comparing what is seen during surgery with the results of laboratory examination of the removed tissue. It will also track any side effects from the tracer for 14 days after injection and measure PSA (prostate specific antigen, a blood test marker for prostate cancer) levels after surgery to assess outcomes.

1 PSMA PET/CT Scan

You will undergo a routine PSMA PET/CT scan within 90 days before your surgery. This scan uses a special tracer to identify areas where prostate cancer may be present.

The results of this scan will help determine if you are eligible for the study and will serve as a reference for comparison during the trial.

2 Receiving the Study Medication

You will receive an injection of the study medication called 99mTc-euk-(so3)cy5-mas3 (also referred to as 99mTc-hPSMA). This is a hybrid tracer that contains both radioactive and fluorescent components designed to attach to prostate cancer cells.

The medication will be given as a single injection in a pre-filled syringe.

3 SPECT/CT Imaging

Depending on which group you are assigned to, you will undergo imaging at different times:

If you are among the first 5 patients (Group A), you will have a SPECT/CT scan at 1 hour after receiving the injection.

All patients (Group A+B, total of 13 patients) will have a SPECT/CT scan at 15 hours after receiving the injection.

These scans will show how the tracer is distributed in your body and identify potential cancer areas.

4 Robotic-Assisted Laparoscopic Prostatectomy (RALP) with Extended Pelvic Lymph Node Dissection

You will undergo robotic-assisted laparoscopic prostatectomy (RALP), a minimally invasive surgical procedure to remove your prostate.

During the same surgery, an extended pelvic lymph node dissection (ePLND) will be performed to remove lymph nodes for examination.

The surgical team will use special equipment to detect both radioactive and fluorescent signals from the tracer during surgery to identify potential cancer areas in your prostate and lymph nodes.

5 Post-Surgery Monitoring

For 14 days after receiving the injection, you will be monitored for any adverse events or side effects related to the study medication.

The research team will use a standardized system called CTCv5 (Common Terminology Criteria for Adverse Events version 5) to classify any side effects that may occur.

6 Laboratory Analysis

After surgery, your removed prostate and lymph nodes will undergo detailed laboratory analysis.

The tissues will be examined under a microscope to confirm the presence of cancer and to determine if the surgical margins (edges of the removed tissue) are free of cancer cells.

The results will be compared with the areas identified by the tracer during surgery to determine how accurate the new imaging method is.

7 Post-operative Follow-up Visit

You will have a follow-up visit approximately 3-6 months after surgery.

During this visit, your PSA (Prostate-Specific Antigen) level will be measured. PSA is a protein produced by the prostate, and its level in the blood can indicate if there is any remaining prostate cancer after surgery.

Who Can Join the Study?

  • You must be a male who is 18 years or older
  • You must have prostate cancer that has been confirmed through tissue examination (adenocarcinoma of the prostate)
  • You must have had a PSMA PET/CT scan (a special type of imaging test that looks for prostate cancer) within 90 days before surgery
  • Your tumor must be PSMA avid (visible on the PSMA PET/CT scan)
  • You must be suitable for RALP +ePLND (robot-assisted laparoscopic prostatectomy with extended pelvic lymph node dissection, which is a type of minimally invasive surgery to remove the prostate and surrounding lymph nodes)
  • You must provide written and signed informed consent to participate in the study

Who Cannot Join the Study?

  • You cannot participate if you are younger than 18 years old.
  • You cannot participate if you have severe allergies to any components used in the study drug.
  • You cannot participate if you have any condition that would make it unsafe for you to have the imaging procedures.
  • You cannot participate if you are unable to lie still for the duration of the imaging procedure.
  • You cannot participate if you have a pacemaker or other implanted electronic devices that might interfere with the imaging equipment.
  • You cannot participate if you have claustrophobia (fear of confined spaces) that would prevent you from completing the imaging scan.
  • You cannot participate if you are pregnant or breastfeeding.
  • You cannot participate if you have had another experimental treatment or participated in another clinical trial within the past 30 days.
  • You cannot participate if you have kidney failure or severe kidney disease.
  • You cannot participate if your doctor believes you are not suitable for the study for any other medical reason.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name City Country Status
Netherlands Cancer Institute Amsterdam The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Not yet recruiting
01.08.2025

Trial locations

Investigated drugs:

99mTechnetium and Cyanine-5 (HybriD) Prostate Specific Membrane Antigen (PSMA) Tracer is an imaging agent used to detect prostate cancer cells. It combines two parts: a radioactive component (99mTechnetium) and a fluorescent dye (Cyanine-5). This dual-action tracer attaches to a protein called PSMA that is found in high amounts on prostate cancer cells. During surgery, this helps doctors to see cancer cells both with special cameras that detect radioactivity and with cameras that can see the fluorescent dye, potentially improving the surgeon’s ability to find and remove cancer tissue.

Investigated diseases:

Prostate cancer A malignant growth of cells in the prostate gland that typically develops slowly over time. The disease begins when cells in the prostate start to grow uncontrollably, often forming a tumor. As prostate cancer progresses, cancerous cells may spread beyond the prostate into surrounding tissues or metastasize to distant parts of the body, particularly the bones and lymph nodes. The disease is often asymptomatic in early stages, but may later cause urinary problems, pain, and erectile dysfunction. Prostate cancer commonly occurs in older men and has varying levels of aggressiveness, with some forms remaining localized while others grow more rapidly and spread.

Trial ID:
2023-505453-40-00
Trial Phase:
Phase I and Phase II (Integrated) – First administration to humans

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