TheranosticTrials.org

Clinical Trial · NCT05622162

Prospective Comparative Study for Patients With Biochemical Recurrence Prostate Cancer Detecting by 18F-JK-PSMA-7

Overview

The present study in patients with Prostate cancer and biochemical failure after surgery and/or radical-postoperative Radio Therapy (RT) will evaluate if PET/CT with 18F-JK-PSMA-7 compared to PET-CT 18F-Choline is able to identify the early pattern of biochemical recurrence and/or metastatic sites, so that the patient could be better managed, with a benefit in survival.

Sponsor

ITEL Telecomunicazioni Srl

Phase

Phase 3

ClinicalTrials.gov

NCT05622162

Drug / Compound

Fluorocholine

Isotope(s):
Target(s):
  • No Explicit Target
Ligand Class: Small Molecules

JK-PSMA-7

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules

Eligibility

Inclusion

  • Patient must have an Eastern Cooperative Oncology Group performance status ≤ 2
  • For patients treated with radical prostatectomy: arise of PSA ≥ 0.2 ng/mL (performed in the last month) or a rise of 2 ng/mL or more above the nadir PSA after definitive radiation therapy defined by two subsequent PSA assessments performed over a 3-month period in the same laboratory
  • Patient must have had their primary PCa treated with surgery and/or radiation therapy; salvage radiation to the prostate bed or pelvis is allowed
  • Histological confirmation of prostate malignancy
  • Absence of any of the exclusion criteria

Exclusion

  • Concomitant active malignancy
  • Inability to lie flat during or tolerate PET/CT
  • Hypersensitivity to active substance or any of excipients of Investigational Medicinal Product or Comparator
  • Participation in a concurrent clinical trial
  • Receipt of any other investigational agents in the previous 3 months
  • Spinal cord compression or impending spinal cord compression
  • More than 3 years of androgen deprivation therapy (ADT), with less than 3 months from the last treatment
  • Subject deprived of its freedom by administrative or legal decision or who is under guardianship
  • ECOG performance status \>2
  • Absence of any of the inclusion criteria;
  • Life expectancy \<6 months