Last updated on July 2019

Ga-68-PSMA-11 in High-risk Prostate Cancer


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Lymphnode Metastasis | High Risk Prostate Cancer | Malignant neoplasm of prostate | Prostate Cancer Metastatic
  • Age: Between 18 - 100 Years
  • Gender: Male

Inclusion Criteria:

  1. Written informed consent.
  2. Male 18 years of age.
  3. Histologically confirmed adenocarcinoma of the prostate.
  4. High risk for metastasis, defined by either:
  5. stadium cT3 according to TNM (primary tumor, regional nodes, metastasis) Classification of Malignant Tumours (TNM), or
  6. Gleason Score >7, or
  7. Prostate-Specific Antigen (PSA) >20 ng/mL.
  8. Patient scheduled for radical prostatectomy (RP) with extended pelvic lymph node dissection (EPLND) according to current guidelines 8 - 42 days after start of study.
  9. Consent to practise contraception until end of study (6 days after Ga-68-PSMA-11 injection).
  10. Preoperative PCA staging performed according to guidelines, to include pelvic MRI or CT and 99mTc bone scintigraphy, not older than 56 days prior to inclusion, according to standard of care.

Exclusion Criteria:

  1. Known hypersensitivity to Ga-68-PSMA-11 or its components.
  2. Presence of known lymph node metastases outside surgical field.
  3. More than 5 bone metastases, as determined by 99mTc bone scintigraphy.
  4. Previous prostate cancer therapy.
  5. Administration of any kind of PET tracer within a period corresponding to 8 half-lives of the respective radionuclide.
  6. Any other investigational medicinal product within 30 days prior and 7 days after receiving study medication.
  7. Evidence of neuroendocrine small cell carcinoma.
  8. Subjects not able to declare meaningful informed consent on their own (e.g. with legal guardian for mental disorders).
  9. Simultaneous participation in other clinical trials

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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