Clinical Trial · NCT03392428

A Trial of 177Lu-PSMA617 Theranostic Versus Cabazitaxel in Progressive Metastatic Castration Resistant Prostate Cancer

Overview

This open label, randomised, stratified, 2-arm, multicentre, phase 2 trial aims to determine the activity and safety of Lu-PSMA vs cabazitaxel in men with progressive metastatic castration resistant prostate cancer

Sponsor

Australian and New Zealand Urogenital and Prostate Cancer Trials Group

Phase

Phase 2

Contacts

Michael Hofman, A/Prof (STUDY_CHAIR)

ClinicalTrials.gov

NCT03392428

Drug / Compound

PSMA-617

Isotope(s):

Target(s):

PSMA

Ligand Class: Small Molecules

Chelator: DOTA

Eligibility

Inclusion

Estimated life expectancy \> 12 weeks
AST or ALT ≤ 2.0 x ULN (or ≤ 5.0 x ULN in the presence of liver metastases)
Neutrophils \> 1.5 x10 billion/L
Castration-resistant prostate cancer (defined as disease progressing despite castration by orchiectomy or ongoing Luteinizing Hormone-Releasing Hormone (LHRH) analog
Progressive disease with rising PSA on 3 consecutive measurements, and PSA ≥ 20 ng/mL
Adequate bone marrow function:
Hb ≥ 90g/L (no red blood cell transfusion in last 4 weeks)
ECOG Performance status 0 to 2
Significant PSMA avidity on 68Ga-PSMA PET/CT, defined as a minimum uptake of SUVmax 20 at a site of disease, and SUVmax \> 10 at sites of measurable disease ≥10mm (unless subject to factors explaining a lower uptake, e.g. respiratory motion, reconstruction artefact)
Target or non-target lesions according to RECIST 1.1
Adequate liver function:
Assessed by a medical oncologist as suitable for chemotherapy with cabazitaxel
Adequate renal function: • Cr Cl ≥ 40mL/min (Cockcroft-Gault formula)
Willing and able to comply with all study requirements, including all treatments (cabazitaxel or Lu-PSMA); and, the timing and nature of all required assessments
Prior treatment with docetaxel
Study treatment both planned and able to start within 21 days of randomisation
Bilirubin \< 1.5 x upper limit of normal (ULN) (or if bilirubin is between 1.5-2x ULN, must have a normal conjugated bilirubin)
Platelets ≥ 100 x10 billion /L
Documented histopathology of prostate adenocarcinoma OR
Metastatic disease typical of prostate cancer (i.e. involving bone or pelvic lymph nodes or para-aortic lymph nodes)

Exclusion

Concurrent illness, including severe infection that may jeopardise the ability of the participant to undergo the procedures outlined in this protocol with reasonable safety
Sjogren's syndrome
Site(s) of disease that are FDG positive with minimal PSMA expression defined as FDG intensity \> 68Ga-PSMA activity OR 68Ga-PSMA SUVmax \< 10
Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse
Prior treatment with cabazitaxel or Lu-PSMA
Contraindications to the use of corticosteroid treatment
Patients who are sexually active and not willing/able to use medically acceptable forms of barrier contraception
Active malignancy other than prostate cancer
Prostate cancer with significant sarcomatoid or spindle cell or neuroendocrine small cell components