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Title: Evaluation of 68Ga-PSMA-11 PET/MRI and PET/CT Imaging for Treatment Planning in Patients with Intermediate and High-Risk Prostate Cancer

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with intermediate and high-risk prostate cancer. The research evaluates a diagnostic method using a radioactive substance called 68Ga-PSMA-11, which is administered through an intravenous injection. This substance is used during special imaging procedures called PET/CT and PET/MRI scans to help locate cancer cells in the body.

The purpose of this study is to determine how well these imaging methods can identify the exact location and spread of prostate cancer. The study includes two groups of patients: those who are newly diagnosed and planning to start treatment, and those who have already received treatment but show signs that their cancer might have returned.

During the study, participants will receive a single dose of the radioactive substance before undergoing the imaging scans. These scans combine different imaging techniques to create detailed pictures of the body that can help doctors better understand where the cancer is located. The maximum dose of the radioactive substance is 2.20 megabecquerels per kilogram of body weight, and the entire imaging procedure takes place on a single day.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial evaluation

    A medical assessment will confirm if you meet the study criteria for one of two groups:

    - Group 1: If you have intermediate or high-risk prostate cancer and are planning radical treatment

    - Group 2: If you have already received radical treatment and show signs of cancer recurrence

  2. Step 2

    Pre-imaging preparation

    Your kidney function will be checked through a blood test measuring creatinine levels

    For Group 1, you need to have completed an MRI scan of the prostate within the past 90 days

    A PSA blood test will be performed to measure prostate-specific antigen levels

  3. Step 3

    Imaging procedures

    You will receive an injection of 68Ga-PSMA-11 through an intravenous line

    Two types of scans will be performed:

    - A PET/CT scan (combines positron emission tomography with computed tomography)

    - A PET/MRI scan (combines positron emission tomography with magnetic resonance imaging)

  4. Step 4

    Follow-up assessment

    The medical team will evaluate the scan results to:

    - Determine the stage of cancer (Group 1)

    - Locate any cancer recurrence (Group 2)

    Your treatment plan may be adjusted based on these findings

  5. Step 5

    Safety monitoring

    You will be monitored for any side effects from the imaging procedures

    The radiation dose from the procedures will be measured and recorded

Who can join the trial?

12 criteria

  • Must be at least 18 years old
  • Must be male
  • Must sign an informed consent form to participate in the study
  • Must have prostate cancer confirmed by tissue examination (biopsy)
  • For Group 1 patients:
    • Must have intermediate or high-risk prostate cancer
    • Must be planning to receive initial treatment
    • Must have healthy kidney function (creatinine levels within acceptable range)
    • Must have had an MRI scan of the prostate within the last 90 days
    • For Group 2 patients:
      • Must have completed initial cancer treatment
      • After surgery: must have specific PSA blood test levels showing possible cancer return
      • After radiation therapy: must have increasing PSA levels indicating possible cancer return
      • If hormone therapy was used: must show three consecutive increases in PSA levels, with current level above 2 ng/mL

Who cannot join the trial?

11 criteria

  • Age below 18 years old
  • Female gender (study is only for male participants)
  • Any known allergies to gallium-68 (68Ga) or other components used in PET imaging (a type of medical scan)
  • Inability to lie still for approximately 30 minutes during the imaging procedure
  • Weight exceeding the imaging equipment's limit (usually 350-440 pounds/160-200 kg)
  • Previous radiation therapy or chemotherapy within the last 30 days
  • Participation in other clinical trials within the last 30 days
  • Presence of any metal implants or devices that would interfere with MRI scanning (such as pacemakers, certain types of implants)
  • Severe claustrophobia (fear of confined spaces) that would prevent completion of imaging procedures
  • Inability to provide informed consent
  • Any condition that, in the opinion of the study investigator, would compromise the safety of the participant or the quality of the study data
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Investigated drugs

68Ga-PSMA-11 is a radioactive tracer used in medical imaging procedures like PET/CT and PET/MRI scans. This substance is designed to bind specifically to prostate cancer cells, making them visible during the scanning process. When injected into the body, it helps doctors to see where prostate cancer may have spread and helps in determining the stage of the disease. This imaging agent is not a treatment itself but rather a diagnostic tool that helps physicians plan the most appropriate treatment for each patient.

What is already known about the treatment

68Ga-PSMA-11 – A radioactive diagnostic imaging agent administered intravenously for PET/CT and PET/MRI scans in patients with prostate cancer. This radiotracer specifically binds to prostate-specific membrane antigen (PSMA), which is typically overexpressed in prostate cancer cells, allowing for precise detection and localization of cancer lesions. It belongs to the class of radiopharmaceuticals used in nuclear medicine and has become an important tool in staging prostate cancer, particularly for intermediate and high-risk cases. The substance helps medical professionals to create detailed images of prostate cancer spread, which aids in planning personalized treatment approaches.

Investigated diseases

Prostate Cancer - A disease that develops in the prostate gland, which is part of the male reproductive system. The cancer begins when cells in the prostate start growing uncontrollably, with intermediate and high-risk forms showing more aggressive patterns of growth. It typically develops slowly in its early stages, though some cases may progress more rapidly. The cancer can remain within the prostate gland or spread to nearby tissues and organs. As it advances, the disease may progress from an intermediate stage, where it's still contained within the prostate region, to a high-risk stage where it shows more aggressive characteristics.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516556-17-00Protocol code2020/ABM/01/00074Estimated enrolment366 patientsSponsorAgencja Badań Medycznych

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