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.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
German Cancer Research Center
Collaborators:
ABX CRO Friedrich-Alexander-Universität Erlange-Nürnberg Friedrich-Alexander-Universität Erlangen-Nürnberg University Hospital Freiburg