In short
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.
Key points
- Clinical trials of 18F-Psma-1007 are focused on prostate cancer, especially staging and treatment planning. The studies include men with newly diagnosed disease, high-risk prostate cancer, and oligo-metastatic hormone-sensitive prostate cancer. Trial phases range from Phase 2 to Phase 4, plus one low-intervention study. Main outcomes include finding lymph node spread, matching scan results with tissue findings, tracking biochemical recurrence, and measuring disease progression. Some trials also look at cost-effectiveness and whether the scan can reduce more invasive procedures.
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.
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.
Who is being studied
The target population is men with prostate cancer, but the exact group changes from study to study.
- Newly diagnosed patients are included in the study that checks pelvic lymph node invasion before surgery.
- High-risk prostate cancer patients are included in the trial that compares PSMA-PET and mpMRI with tissue findings.
- Oligo-metastatic hormone-sensitive patients are included in the study that looks at outcomes after PSMA-based treatment versus standard care.
- Another study includes patients being staged for possible lymph node spread at the start of treatment.
What the trials measure
The main goal in these trials is to see how well 18F-Psma-1007 helps find cancer and guide care.
- One primary outcome is the proportion of subjects with local lymph node metastases, which means cancer spread to nearby lymph nodes.
- Another study measures biochemical recurrence within two years after surgery, defined as PSA higher than 0.2 ng/ml.
- The high-risk prostate cancer study checks whether scan findings match histopathology, meaning tissue examined under a microscope.
- The metastatic study measures the fraction of patients with disease progression within 6 months and the time to progression.
- 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.
Trial phases and status
The trials include different development stages, which helps show how the research is being used in practice.
- Phase 4: one authorised study in primary prostate cancer staging with 320 planned participants.
- Phase 3: one authorised study in high-risk prostate cancer with 20 planned participants.
- Phase 2: one completed study in oligo-metastatic hormone-sensitive prostate cancer with 58 participants.
- Low intervention: one authorised study with 742 planned participants that focuses on cost-effectiveness and treatment selection.
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.
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.
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.