TheranosticTrials.org

Clinical Trial · NCT02810886

Prospective Evaluation of 68Ga-PSMA PET-CT for Recurrence Detection of Prostate Cancer and Its Impact on Patient Management

Overview

Single arm, phase II exploratory trial to prospectively evaluate the impact of 68Ga-PSMA-PET/CT on the therapeutic management of patients with biological recurrent prostate cancer and negative, equivocal or oligometastatic disease after routine imaging diagnostic work-up.

Sponsor

Jules Bordet Institute

Phase

Phase 2

Contacts

Carlos Artigas, MD (STUDY_CHAIR)

ClinicalTrials.gov

NCT02810886

Drug / Compound

PSMA-11

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

Eligibility

Inclusion

  • ECOG performance status ≤ 2
  • Following Radical Prostatectomy +/- Radiotherapy: a serum PSA increase confirmed by a second PSA measurement higher than the first one with a value of 0.2 ng/mL or more within minimum of one week.
  • Routing Imaging Workup exams are accepted when performed within 1 month before PSMA-PET/CT (this includes WB-MRI, prostatic/pelvic MRI, and/or Bone Scintigraphy).
  • Patients with negative, inconclusive or oligometastatic disease on the Routine Imaging Workup and susceptible to be treated with curative radical intent (salvage treatment).
  • Following primary Radiotherapy: PSA value of 2 ng/ml above the nadir.
  • A continued rise in PSA level despite treatment with curative intent.
  • Biochemical recurrence (BCR) after local treatment with radical curative intent based on PSA values 1:
  • Patient treatment strategy based on routine diagnostic work-up needs to be recorded after discussion at the Urologic Tumor Board and available before the PSMA PET/CT.
  • Histologically-proven prostate adenocarcinoma.

Exclusion

  • Previous malignancy other than Prostate Cancer (except basocellular or squamous cell skin cancer).
  • Previous treatment with isotopes (Radium, Samarium, Strontium, etc.)
  • Known allergy/sensitivity to 68Ga or HBED-CC coupled substance, or any of the ingredient(s) or excipient(s) of the study medication(s)
  • Patients treated with palliative chemotherapy or new hormonal therapies like Abiraterone/Enzalutamide.
  • Metastatic patients before inclusion not considered for targeted therapy.
  • All medical conditions that might interfere with the correct performance of imaging scans.
  • Medical castration with Testosterone \< 50 ng/dl (1.7 nmol/L).
  • PSA rise while on active treatment (LHRH-agonist, LHRH-antagonist, anti-androgen, maximal androgen blockade, oestrogen). A minimal time window of 1 month is required.