High-risk Prostate Cancer Prostate Cancer Metastatic Lymphnode Metastasis C61
Conditions
Interventions
Group 1: After consenting, review of inclusion and exclusion criteria, as well as screening investigations will be performed by the uro-oncologist (day 0). Thereafter, patients are referred to the col
150 MBq (+/- 50 MBq)), imaging (PET-CT/CT optionally PET-MRI), and post-dose safety evaluations (day 1). Subsequent investigations (day 2 and at end of study) will be made by the uro-oncologist or exp
Sponsors
Deutsches Krebsforschungszentrum (DKFZ) Heidelberg
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion 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: a. stadium cT3 according to TNM classification, or b. Gleason Score >7, or c. PSA >20 ng/mL. 5. Patient scheduled for radical prostatectomy (RP) with extended pelvic lymph node dissection (EPLND) according to current guidelines 8 - 42 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 pelvic MRI or CT and 99mTc bone scintigraphy, not older than 56 days prior to inclusion, according to standard of care.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - True positive fraction (TPF) and false positive fraction (FPF) of identified tumour tissue in soft tissue, analysed separately for prostate gland and pelvic lymph nodes, after localization of tumor tissue on the PET/CT scan, using histopathology as standard of truth.; time frame: up to day 42 - Frequency of occurrence and severity of abnormal findings in safety investigations (physical examination, vital signs, 12-lead ECG, pulse oximetry, clinical laboratory, adverse events, concomitant medication).; time frame: Day 0 - Day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| - Number of identified bone lesions, per patient.; time frame: Day 1 - Correlation coefficient of recovery-corrected SUV (standardized uptake value) values plotted against Gleason score in primaries after RP; time frame: Day 1 - Percentage of subjects for whom the RP and EPLND will not be conducted; time frame: Day 1 - Quantity of circulating tumour cells in blood; time frame: Day 1 | — |
Countries
Austria, Germany, Switzerland
Contacts
Public ContactFrederik Giesel
Universität Heidelberg, Radiologische Universitätsklinik, Nuklearmedizin
Outcome results
None listed