TheranosticTrials.org

Clinical Trial · NCT03362359

Ga-68-PSMA-11 in High-risk Prostate Cancer

Overview

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.

Sponsor

Unknown Organization

Phase

Phase 1/2

Contacts

Frederik Giesel, Prof. Dr. (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT03362359

Drug / Compound

PSMA-11

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
Chelator: HBED-CC
Linker: Ahx

Eligibility

Inclusion

  • Histologically confirmed adenocarcinoma of the prostate.
  • stadium cT3 according to TNM (primary tumor, regional nodes, metastasis) Classification of Malignant Tumours (TNM), or
  • 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.
  • Patient scheduled for radical prostatectomy (RP) with extended pelvic lymph node dissection (EPLND) according to current guidelines 7 - 60 days after start of study.
  • Prostate-Specific Antigen (PSA) \>20 ng/mL.
  • High risk for metastasis, defined by either:
  • Consent to practise contraception until end of study (6 days after Ga-68-PSMA-11 injection).
  • Gleason Score \>7, or

Exclusion

  • Any other investigational medicinal product within 30 days prior and 7 days after receiving study medication.
  • More than 5 bone metastases, as determined by 99mTc bone scintigraphy.
  • Known hypersensitivity to Ga-68-PSMA-11 or its components.
  • Previous prostate cancer therapy.
  • Presence of known lymph node metastases outside surgical field.
  • Administration of any kind of PET tracer within a period corresponding to 8 half-lives of the respective radionuclide.
  • Simultaneous participation in other clinical trials