In Men With Metastatic Prostate Cancer What is the Safety and Benefit of Lutetium-177 PSMA Radionuclide Treatment in Addition to Chemotherapy

  • End date
    Apr 14, 2024
  • participants needed
  • sponsor
    Peter MacCallum Cancer Centre, Australia
Updated on 14 January 2021
Primary Contact
St Vincent's Hospital Sydney (8.2 mi away) Contact
+4 other location


This phase 2 randomised clinical trial will compare the effectiveness of Lu-PSMA therapy followed by docetaxel chemotherapy versus docetaxel chemotherapy on its own in patients with newly-diagnosed high-volume metastatic hormone-naive prostate cancer (mHNPC).


This is an open label, randomised, stratified, 2-Arm, multi-centre, phase 2 clinical trial recruiting 140 newly-diagnosed high-volume mHNPC patients at 11 Australian centres over a period of 18 months. Patients will be randomised to the experimental Arm (177Lu-PSMA followed by docetaxel) or standard-of-care Arm (docetaxel) in a 1:1 ratio. All patients will receive ADT continuously throughout the trial. Patients will be stratified according to disease volume by conventional imaging (low-volume vs. high-volume) and duration of ADT at time of registration ( 28 days vs. > 28 days).

Treatment docetaxel, 177Lu-PSMA-617
Clinical Study IdentifierNCT04343885
SponsorPeter MacCallum Cancer Centre, Australia
Last Modified on14 January 2021

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Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Are you male?
Do you have Metastatic Hormone Naive Prostate Cancer?
Do you have any of these conditions: Do you have Metastatic Hormone Naive Prostate Cancer??
Do you have any of these conditions: Do you have Metastatic Hormone Naive Prostate Cancer??
Do you have any of these conditions: Do you have Metastatic Hormone Naive Prostate Cancer??
Do you have any of these conditions: Do you have Metastatic Hormone Naive Prostate Cancer??
Significant PSMA avidity on 68Ga-PSMA PET/CT, defined after central review as a minimum uptake of SUVmax 15 at a site of disease
High-volume metastatic disease on 68Ga-PSMA PET/CT defined as visceral metastases or 4 bone metastases with 1 outside the vertebral column and pelvis (extra-axial skeleton)
Patient continues to meet all the inclusion criteria for registration

Exclusion Criteria

Major FDG-PET discordance defined as presence of FDG positive disease with minimal PSMA expression in multiple sites (>5) or in more than 50% of total disease volume
All the exclusion criteria for registration continue to not apply
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