Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
German Cancer Research Center
With
ABX CRO
Friedrich-Alexander-Universität Erlangen-Nürnberg
University Hospital Freiburg
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
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:
1. stadium cT3 according to TNM (primary tumor, regional nodes, metastasis) Classification of Malignant Tumours (TNM), or
2. Gleason Score \>7, or
3. Prostate-Specific Antigen (PSA) \>20 ng/mL.
5. Patient scheduled for radical prostatectomy (RP) with extended pelvic lymph node dissection (EPLND) according to current guidelines 7 - 60 days after start of study.
6. Consent to practise contraception until end of study (6 days after Ga-68-PSMA-11 injection).
7. Preoperative PCA staging performed according to guidelines, to include a mandatory 99mTc bone scintigraphy and an optional pelvic MRI or CT, not older than 56 days prior to inclusion, according to standard of care.
You may not be if
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
