18F-Psma-1007

Clinical trials of 18F-Psma-1007 are studying how well this imaging tracer helps find prostate cancer, especially lymph node spread and aggressive lesions. The trials look at accuracy, cost-effectiveness, and outcomes in men with newly diagnosed, high-risk, or metastatic hormone-sensitive prostate cancer.

Table of contents

Trial overview

The listed studies of 18F-Psma-1007 all focus on prostate cancer and use it in imaging-based research, mainly with PET/CT scanning.[1][2][3][4]

One trial compares PSMA-PET/CT with current guideline imaging for primary staging, another looks at cost-effectiveness and treatment selection, a third compares scan findings with histopathology, and a fourth studies treatment outcomes in oligo-metastatic hormone-sensitive disease.[1][2][3][4]

Who is being studied

The target population is men with prostate cancer, but the exact group changes from study to study.[1][2][3][4]

  • Newly diagnosed patients are included in the study that checks pelvic lymph node invasion before surgery.[2]

  • High-risk prostate cancer patients are included in the trial that compares PSMA-PET and mpMRI with tissue findings.[3]

  • Oligo-metastatic hormone-sensitive patients are included in the study that looks at outcomes after PSMA-based treatment versus standard care.[4]

  • Another study includes patients being staged for possible lymph node spread at the start of treatment.[1]

What the trials measure

The main goal in these trials is to see how well 18F-Psma-1007 helps find cancer and guide care.[1][2][3][4]

  • One primary outcome is the proportion of subjects with local lymph node metastases, which means cancer spread to nearby lymph nodes.[1]

  • Another study measures biochemical recurrence within two years after surgery, defined as PSA higher than 0.2 ng/ml.[2]

  • The high-risk prostate cancer study checks whether scan findings match histopathology, meaning tissue examined under a microscope.[3]

  • The metastatic study measures the fraction of patients with disease progression within 6 months and the time to progression.[4]

  • The cost-effectiveness study also looks at whether PSMA-PET/CT can reduce the need for extended pelvic lymph node dissection and lower overall healthcare costs.[2]

Trial phases and status

The trials include different development stages, which helps show how the research is being used in practice.[1][2][3][4]

  • Phase 4: one authorised study in primary prostate cancer staging with 320 planned participants.[1]

  • Phase 3: one authorised study in high-risk prostate cancer with 20 planned participants.[3]

  • Phase 2: one completed study in oligo-metastatic hormone-sensitive prostate cancer with 58 participants.[4]

  • Low intervention: one authorised study with 742 planned participants that focuses on cost-effectiveness and treatment selection.[2]

What these studies mean for patients

These trials are not mainly testing 18F-Psma-1007 as a treatment; they are testing how useful it is as an imaging tool in prostate cancer care.[1][2][3][4]

For patients, this kind of research may help doctors find disease spread earlier, choose the right treatment path, and avoid procedures that may not be needed.[2][3]

Across the listed trials, the main questions are whether 18F-Psma-1007 improves detection, matches tissue results, supports better treatment decisions, and helps measure outcomes more accurately.[1][2][3][4]

Trial IDPhaseCondition studiedStatusEnrollment
NCT06219746Phase 4Prostate cancerAuthorised320
2024-518171-59-00Low InterventionProstate CancerAuthorised742
2022-501892-14-00Phase 3Prostate cancerAuthorised20
NCT04443062Phase 2prostate cancerCompleted58

Ongoing Clinical Trials on 18F-Psma-1007

  • Study of 99mTc-MIP-1404 SPECT/CT imaging compared to standard imaging methods for detecting lymph node metastases in patients with prostate cancer

    Recruiting

    1 1 1 1
    Investigated diseases:
    Finland
  • Study on the Use of 18F-PSMA-1007, Hyoscine Butylbromide, and Gadoteric Acid in Imaging for Patients with High-Risk Prostate Cancer

    Recruiting

    1 1 1 1
    Investigated diseases:
    Sweden
  • Study on the Use of 18F-PSMA-1007, Piflufolastat (18F), and Gozetotide for Detecting Pelvic Lymph Node Invasion in Newly Diagnosed Prostate Cancer Patients

    Not recruiting

    1 1 1 1
    Investigated diseases:
    The Netherlands
  • Study on Lutetium-177-PSMA and 18F-PSMA-1007 for Patients with Oligo-metastatic Hormone Sensitive Prostate Cancer

    Not recruiting

    1 1 1
    Cyprus The Netherlands

Glossary

  • Prostate cancer: A cancer that starts in the prostate gland, which is part of the male reproductive system.
  • PET/CT: A scan that combines two imaging tests. PET shows how active tissue is, and CT shows detailed body structure.
  • PSMA: A target used in prostate cancer imaging. In these trials, it helps doctors look for cancer cells more clearly on scans.
  • Primary staging: The first check of how far a cancer has spread when it is first found.
  • Lymph nodes: Small glands that are part of the immune system. Cancer can spread to them.
  • Metastasis: Cancer that has spread from the original tumor to another part of the body.
  • Histopathology: Study of tissue under a microscope. It is used here to confirm what the scan finds.
  • Biochemical recurrence: A rise in PSA after treatment that can mean the cancer has come back.
  • Progression: When cancer gets worse or spreads further.
  • Oligo-metastatic: A small number of metastases, or spread areas, found in the body.

References