TheranosticTrials.org

Clinical Trial · NCT04430192

Dosimetry, Safety and Potential Benefit of 177Lu-PSMA-617 Prior to Prostatectomy

Overview

This clinical trial will evaluate the dosimetry, efficacy and toxicity of Lu-PSMA in men with high PSMA-expressing high-risk localized or locoregional advanced prostate cancer (HRCaP) undergoing radical prostatectomy (RP) and pelvic lymph node dissection (PLND)

Sponsor

Peter MacCallum Cancer Centre

Phase

Phase 1/2

Contacts

Declan Murphy (PRINCIPAL_INVESTIGATOR)

John Violet (PRINCIPAL_INVESTIGATOR)

Michael S Hofman (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT04430192

Drug / Compound

PSMA-617

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

Eligibility

Inclusion

  • N1 disease (involvement of lymph nodes at or below the bifurcation of the common iliac arteries)
  • Normal baseline haematological function; haemoglobin 13.5-17.5g/dl), total white blood cell count (4-11 x 109/l), platelets (150-400 x 109/l), neutrophils (2-7.5 x 109/l) and lymphocytes (1-4 x 109/l)
  • PSA \> 20 ng/mL
  • Willing and able to comply with all study requirements including all treatments and required assessments including follow up
  • High or high-intermediate risk localised or locoregional prostate cancer (HRCaP) by European Association of Urology (EAU) criteria, including any of the following:
  • High PSMA avidity on 68Ga-PSMA PET/CT, defined as an SUVmax of ≥ 20
  • Histologically confirmed adenocarcinoma of the prostate, in a patient scheduled for RP and PLND with curative intent
  • defined radiologically (CT/ MRI, or PSMA PET).
  • Clinical T-stage by digital rectal examination (DRE) of T2c or higher
  • ISUP grade group 3-5
  • Normal baseline serum biochemistry; sodium 135-145 nmol/l, potassium 3.5-5 nmol/l, chloride 98-108 nmol/l, urea 3-9.2 nmol/l, creatinine 60-120μmol/l

Exclusion

  • Prior treatment for prostate cancer including radiotherapy and/or androgen deprivation therapy.
  • Evidence of metastatic disease involving bone, viscera, or lymph nodes superior to the common iliac bifurcation based on CT, MRI, WBBS or PSMA PET/CT.
  • Sjogren's syndrome.
  • Prostate cancer with significant neuroendocrine or other rare variant pathology
  • A history of or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.
  • Renal impairment \[GFR \< 60mL/min\].