Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2025-12-24 @ 2:46 PM
NCT ID:
NCT03362359
Eligibility Criteria:
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:
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.
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
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT03362359
Study Brief:
Protocol Section:
NCT03362359