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64CU-PSMA I&T

Clinical trials are studying 64CU-PSMA I&T in men with newly diagnosed prostate cancer. These trials are looking at how well PET/CT scanning can find spread to pelvic lymph nodes before surgery. The main focus is diagnostic accuracy, especially sensitivity and specificity, in patients with unfavorable intermediate-risk, high-risk, or very high-risk disease.

Table of contents

Trial overview

Two interventional Phase 3 trials studied 64CU-PSMA I&T in men with newly diagnosed prostate cancer.[1][2] Both trials used PET/CT, which is a combined scan used to look for possible cancer spread in the body.[1][2]

The trials were designed to test the diagnostic performance of the scan, meaning how well it can find disease or show that disease is not present.[1][2] The focus was on pelvic lymph node metastasis, which means cancer spread to lymph nodes in the pelvis.[1][2]

Who was studied

The target group was pre-prostatectomy patients, meaning men being evaluated before prostate surgery.[1][2] The trials specifically included men with unfavorable intermediate-risk, high-risk, or very high-risk prostate cancer.[1][2]

This group was chosen because the trials aimed to check whether the scan could find hidden spread to pelvic lymph nodes before surgery.[1][2]

What the trials measured

The main outcomes were sensitivity and specificity of copper Cu 64 PSMA I&T PET/CT.[1][2] Sensitivity checks how well the scan finds metastatic pelvic lymph nodes when they are truly present.[1][2]

Specificity checks how well the scan shows that pelvic lymph nodes are not involved when they are truly negative.[1][2] These outcomes were compared with histopathology, which is a microscope test of tissue and is used here as the reference standard.[1][2]

Trial status and size

One trial was withdrawn, and the other was completed.[1][2] Each trial planned an enrollment of 323 participants.[1][2]

Both studies used the same phase, condition, and main outcome measures, so they appear to be closely related trial records.[1][2]

How the imaging was judged

A true positive meant the PET scan showed at least one positive pelvic lymph node and histopathology also found a positive lymph node on the same side of the pelvis.[1][2] A true negative meant the scan and histopathology both showed negative pelvic lymph nodes on the same side.[1][2]

This patient-level approach was used to judge whether the scan could reliably detect or rule out lymph node spread before prostate surgery.[1][2]

FAQ

  • What are the 64CU-PSMA I&T trials studying? These trials are studying whether 64CU-PSMA I&T PET/CT can detect pelvic lymph node spread in men with newly diagnosed prostate cancer. The goal is to see how accurately the scan shows whether cancer has spread or not.
  • Who can take part in these trials? The trials focused on pre-prostatectomy patients with unfavorable intermediate-risk, high-risk, or very high-risk prostate cancer. This means men who were being evaluated before surgery were the target group.
  • What phase are these trials? Both listed trials are Phase 3 studies. Phase 3 trials usually test how well a study method or treatment works in a larger group of people.
  • What results are the trials measuring? The main results are sensitivity and specificity. Sensitivity means how well the scan finds lymph node metastasis, and specificity means how well it shows when lymph nodes are not involved.
  • What is the status of the trials? One trial was withdrawn and the other was completed. Both trials had the same study focus and enrollment goal of 323 participants.

Ongoing Clinical Trials on 64CU-PSMA I&T

  • Study on the Use of 64Cu-PSMA I&T to Detect Lymph Node Spread in Men with Newly Diagnosed Prostate Cancer Before Surgery

    Not yet recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France Italy Spain

  • Study on the Use of 64Cu-PSMA I&T to Detect Lymph Node Spread in Men with Newly Diagnosed Prostate Cancer Before Surgery

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France Italy Spain

Glossary

  • Prostate cancer: A cancer that starts in the prostate, a gland in men.
  • Pelvic lymph nodes: Small immune system glands in the pelvis that can be a place where cancer spreads.
  • Metastasis: Spread of cancer from the original place to another part of the body.
  • PET/CT: A scan that combines two imaging methods: PET shows areas of activity, and CT shows detailed body pictures.
  • Histopathology: A lab test that looks at tissue under a microscope to check for cancer.
  • Sensitivity: How well a test finds disease when the disease is really there.
  • Specificity: How well a test shows no disease when the disease is really not there.
  • Pre-prostatectomy: Before prostate surgery.
  • Unfavorable intermediate-risk: A prostate cancer risk group that is more concerning than lower-risk disease.
  • High-risk: A cancer group with a greater chance of spreading or returning.
  • Very high-risk: A cancer group with an even greater chance of serious spread or return.

References

  1. https://clinicaltrials.gov/study/2024-512754-16-00
  2. https://clinicaltrials.gov/study/2024-512754-16-01