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Study of GOZETOTIDE PET/CT added to mpMRI for detecting clinically significant prostate cancer in men undergoing primary diagnosis

Verified siteRegistered drugNo placebo
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What is this trial about?

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

The study focuses on men with clinically significant prostate cancer and evaluates whether adding a special imaging test called PSMA-PET/CT to the usual magnetic resonance scan (mpMRI) improves detection of cancer that requires treatment. The PET/CT scan uses a tiny amount of a radioactive substance, gozetotide, which is injected into a vein before the scan.

The purpose is to determine if the combined imaging approach can more reliably identify cancer that needs therapy. Participants will first undergo the standard MRI, then receive the PET/CT scan, followed by the routine prostate biopsy to confirm the results. After the procedures, they will fill out short questionnaires about urinary symptoms, sexual function, overall health, and anxiety, and any side effects will be tracked for about a month. The study will also look at the safety of the radiotracer, compare costs, and see how well the imaging matches the actual tumor found during surgery for those who have an operation.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline Assessment

    After joining the study you will complete several questionnaires that ask about urinary symptoms, sexual function, overall health, and emotional well‑being. These questionnaires are known as IPSS, IIEF, EQ5D‑5L, and the Hospital Anxiety and Depression Scale. They help the research team understand your condition before any procedures are performed.

    Your medical history and any current medications will be recorded to ensure safety during the trial.

  2. Step 2

    Multiparametric MRI Scan

    You will undergo a standard magnetic resonance imaging scan of the prostate, called mpMRI. This scan provides detailed pictures of the prostate tissue and helps identify areas that may need further examination.

  3. Step 3

    PSMA PET/CT Imaging

    A small amount of the drug gozetotide (contained in the product Locametz) will be injected into a vein. The dose is 25 µg given as a single intravenous injection.

    After the injection you will be taken to a scanner for a combined positron emission tomography and computed tomography examination, known as PSMA PET/CT. The drug helps highlight cancer cells so they can be seen clearly on the images.

  4. Step 4

    Prostate Biopsy

    Based on the results of the mpMRI and PSMA PET/CT scans, a prostate tissue sample will be taken. The biopsy may be performed in a targeted way (focusing on suspicious areas) and/or in a systematic way (sampling multiple standard locations).

    The biopsy can be performed through the perineum (transperineal) or through the rectum (transrectal). Antibiotics may be given before the procedure to reduce the risk of infection.

  5. Step 5

    Pathology Evaluation

    The tissue obtained from the biopsy will be examined under a microscope to determine whether clinically significant prostate cancer is present.

    If the initial biopsy does not show cancer, a repeat systematic biopsy will be scheduled within 6 months. This repeat procedure follows the same steps as the first biopsy.

  6. Step 6

    Follow‑Up Questionnaires

    After the biopsy you will again complete the same set of questionnaires (IPSS, IIEF, EQ5D‑5L, Hospital Anxiety and Depression Scale) to record any changes in symptoms or quality of life.

  7. Step 7

    Side‑Effect Monitoring

    For up to 30 days after the biopsy you will be asked to report any side effects, such as pain, bleeding, or urinary problems, using the PROBE questionnaire. This information helps assess the safety of the procedures.

  8. Step 8

    Optional Surgical Evaluation

    If you later undergo radical prostatectomy (surgical removal of the prostate), the tissue removed during surgery will be compared with the imaging findings from mpMRI and PSMA PET/CT to evaluate how accurately the scans identified cancer.

Who can join the trial?

5 criteria

  • Must be a man who is at least 18 years old.
  • Must have a blood test result called PSA (prostate‑specific antigen) that is between 3 and 20 ng/mL, indicating a suspicion of prostate cancer.
  • Must have had a special MRI scan called mpMRI that shows a PI‑RADS score of 4 or 5 (a rating that means a high chance of significant cancer) performed no more than three months before joining the study.
  • Must be planning to have a tissue sample taken and examined under a microscope (histologic confirmation) to confirm the cancer.
  • Must sign and date a written form that explains the study and agrees to take part (informed consent).

Who cannot join the trial?

8 criteria

  • Men who already have been diagnosed with prostate cancer.
  • Men who have already had a prostate biopsy (biopsy = a small tissue sample taken from the prostate for testing).
  • Men who are allergic (hypersensitivity) to the imaging agent [68Ga]Ga-PSMA-11 or any of its ingredients.
  • Men who have had a serious infection in the past 8 weeks, such as a urinary tract infection, prostatitis (inflammation of the prostate), or gastroenteritis (stomach flu).
  • Men who have a long‑term history of chronic prostatitis (ongoing inflammation of the prostate).
  • Men who have received any other PET tracer (a radioactive substance used for imaging) within a time equal to 8 half‑lives of that tracer (the period it takes for half of the radioactivity to disappear).
  • Men who have taken any other experimental medication (investigational medicinal product) within 30 days before starting the study and until the final visit.
  • Men who cannot lie flat, stay still, or tolerate the PET scan procedure.
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Investigated drugs

Locametz is a radiopharmaceutical used in PET scans. It contains a substance that helps the imaging machine see areas of the prostate that may have cancer. In the trial, participants receive this injection before a special type of PET/CT scan called PSMA‑PET. The scan looks for signals that indicate clinically significant prostate cancer, allowing doctors to compare the new imaging method with the standard MRI technique. This helps determine whether adding the PSMA‑PET scan improves the accuracy of diagnosing prostate cancer.

What is already known about the treatment

Gozetotide - Gozetotide is given as a tiny amount (25 µg) in a liquid that is injected into a vein. It is an investigational imaging agent that is still being studied and is not yet a standard medicine. The drug helps doctors see prostate cancer by attaching to a protein on cancer cells and allowing a special PET/CT scan to highlight the tumors. It belongs to the class of PSMA‑targeting radiopharmaceuticals used for diagnostic imaging.

Investigated diseases

Clinically significant prostate cancer - Clinically significant prostate cancer is a form of cancer that arises from the cells of the prostate gland, a small organ that produces fluid for semen. It begins as a small cluster of abnormal cells that can grow and form a tumor within the prostate. As the tumor enlarges, it may extend beyond the prostate capsule into surrounding tissues such as the seminal vesicles. The disease can also spread through the lymphatic system to nearby lymph nodes and through the bloodstream to distant bones or other organs. Over time, the cancerous tissue can replace normal prostate tissue, affecting the organ’s normal function.
Trial detailsLast updated 5 Nov 2026
Age18+ yearsPhasePhase IITrial ID2026-527906-19-00Protocol codeBZKF-PRIMEEstimated enrolment150 patientsSponsorKlinikum der Technischen Universitaet Muenchen (TUM Klinikum)

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