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

  • STATUS
    Recruiting
  • End date
    Apr 14, 2024
  • participants needed
    140
  • sponsor
    Peter MacCallum Cancer Centre, Australia
Updated on 14 January 2021
Investigator
Arun Azad, MBBS PhD FRACP
Primary Contact
St Vincent's Hospital Sydney (8.2 mi away) Contact
+4 other location

Summary

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).

Description

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).

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

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Eligibility

Yes No Not Sure

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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