TheranosticTrials.org

Clinical Trial · NCT03327675

High Precision Imaging of Prostate Specific Membrane Antigen for Personalized Treatment in Prostate Cancer

Overview

This is an Investigator Initiated, non-commercial, single center, non-randomized, single arm, open label pilot study on 194 patients. The patients are affected by prostate cancer but in two different clinical settings. The first group is characterized by patients who are going to be operated of radical prostatectomy and they will undergo the study imaging preoperatively. The second group experiences biochemical relapse after primary treatment.

Sponsor

Unknown Organization

Phase

N/A

Contacts

Karolien Goffin, MD, PhD (CONTACT)

karolien.goffin@uzleuven.be

003216343714

Karolien Goffin, MD, PhD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT03327675

Drug / Compound

PSMA-11

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

Eligibility

Inclusion

  • previous treatment with cytotoxic agent for PCa
  • treatment during the past month with products known to influence PSA levels (e.g. fluconazole, finasteride, corticosteroids,…)
  • symptomatic metastases
  • WHO performance state 0-1
  • biochemical relapse (two consecutive PSA≥0.2 ng/ml) of prostate cancer following radical local prostate treatment
  • histologically proven diagnosis of prostate cancer
  • a risk of equal or more than 5% of lymph node metastasis (intermediate to high risk disease), according to the Briganti nomogram (1)
  • scheduled to undergo radical prostatectomy with extended lymph node dissectionWork-unit 2
  • Inclusion criteriaWork-unit 1
  • previous pelvic irradiation or radical prostatectomy.
  • WHO performance status \> 2
  • involvement of pelvic lymph nodes assessed by multi-parametric MRI
  • any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.Work-unit 2
  • local relapse on MRI
  • other malignancy except adequately treated basal cell carcinoma of the skin diagnosed during the last 5 years
  • evidence for bone metastasis assessed by bone scan (if PSA \> 20 ng/ml)
  • serum testosterone level \<50ng/ml
  • PSA rise while on active treatment with LHRH-agonist, LHRH-antagonist, Anti-androgen, Complete androgen blockade, Oestrogen-antioestrogen therapy

Exclusion

Exclusion criteria not yet provided.