Ga-68-PSMA-11 in High-risk Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT03362359|
Recruitment Status : Completed
First Posted : December 5, 2017
Last Update Posted : July 27, 2020
This will be an open-label, single-arm, rater-blinded, multicenter, diagnostic phase 1/2 study to assess safety and diagnostic performance of Ga-68-PSMA-11 positron emission tomography / computer tomography (PET/CT) imaging to detect tumour tissue in patients with newly diagnosed PCA and a high risk for metastasis. As standard of truth, comprehensive histopathology covering prostate and the tributary pelvic lymph node system, will be used. Therefore, only patients scheduled for RP with EPLND (as part of their standard of care) will be eligible.
Patients will be recruited at up to 11 uro-oncological sites in Germany, Austria, and Switzerland, with access to a radiopharmaceutical laboratory, experienced to prepare 68Ga-labelled compounds, and high-quality PET/CT imaging. Upon histological confirmation of PCA, pre-operative staging will be performed according to European Association of Urology (EAU) guideline [Mottet et al. 2015] (to include pelvic MRI or CT and a 99mTc-bone scan), to establish the indication for RP with EPLND. If the indication is confirmed, patients will be invited to participate in the present study. 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 collaborating nuclear medicine department for tracer injection, imaging, and post-dose safety evaluations (day 1). Subsequent investigations (day 2 and at end of study) will be made by the uro-oncologist or experienced nuclear medicine physician. Study participation ends on day 7. Routine surgery (RP with EPLND) will be performed after end of study, but no later than 42 days after study inclusion. This sequence allows adequate characterisation of tracer safety, while at the same avoiding unnecessary delay of, or confounding safety signals from therapy.
In total, 150 evaluable patients will be included to receive a single 68Ga dose of 150 MBq (± 50 MBq), administered as i.v. infusion. Due to an assumed dropout rate of 15%, up to 173 patients will be included in study.
|Condition or disease||Intervention/treatment||Phase|
|High-risk Prostate Cancer Prostate Cancer Prostate Cancer Metastatic Lymphnode Metastasis||Drug: Ga-68-PSMA-11||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||173 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Single-arm, Rater-blinded, Multicenter Phase 1/2 Study to Assess Safety and Diagnostic Accuracy and Radiotherapeutic Implications of Pre-operative Ga-68-PSMA-11 PET/CT Imaging in Comparison to Histopathology, in Newly-diagnosed Prostate Cancer (PCA) Patients at High Risk for Metastasis, Scheduled for Radical Prostatectomy (RP) With Extended Pelvic Lymph Node Dissection (EPLND)|
|Actual Study Start Date :||October 9, 2017|
|Actual Primary Completion Date :||July 6, 2020|
|Actual Study Completion Date :||July 6, 2020|
Single administration of 150 MBq (± 50 MBq), corresponding to a mass dose of ≤ 6 µg. A 2nd administration of 150 MBq (± 50 MBq), corresponding to a mass dose of ≤ 6 µg is possible in the unlikely case of a negative histological result (i.e. no prostate-specific membrane antigen (PSMA) expression in dissected lymph nodes) to verify if PSMA PET-positive tissue as seen on day 1 has not been removed during RP with EPLND.
- 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, using histopathology as standard of truth. [ Time Frame: up to day 21 ]
- 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 ]
- Number of identified bone lesions, per patient. [ Time Frame: Day 1 ]
- Correlation coefficient of recovery-corrected standardized uptake values (SUV) 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03362359
|Medizinische Universität Innsbruck|
|Innsbruck, Austria, 6020|
|Universitätsklinikum Carl Gustav Carus Dresden|
|Dresden, Germany, 01307|
|Erlangen, Germany, 91054|
|Essen, Germany, 45147|
|Freiburg, Germany, 79106|
|Heidelberg, Germany, 69120|
|Technische Universität München Klinikum rechts der Isar|
|München, Germany, 81675|
|Tübingen, Germany, 72076|
|Principal Investigator:||Frederik Giesel, Prof. Dr.||University Hospital Heidelberg|