Status:
COMPLETED
A Trial of 177Lu-PSMA617 Theranostic Versus Cabazitaxel in Progressive Metastatic Castration Resistant Prostate Cancer
Lead Sponsor:
Australian and New Zealand Urogenital and Prostate Cancer Trials Group
Collaborating Sponsors:
Australian Nuclear Science and Technology Organisation (ANSTO)
Endocyte
Conditions:
Cancer of the Prostate
Metastatic Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
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 p...
Detailed Description
Despite recent advances in the treatment of prostate cancer, metastatic disease remains incurable. Prostate specific membrane antigen (PSMA) is present in high quantities on the cell surface of prost...
Eligibility Criteria
Inclusion
- Male aged 18 or older with metastatic adenocarcinoma of the prostate defined by:
- 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)
- 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
- Target or non-target lesions according to RECIST 1.1
- Prior treatment with docetaxel
- 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)
- ECOG Performance status 0 to 2
- Assessed by a medical oncologist as suitable for chemotherapy with cabazitaxel
- Adequate renal function:
- • Cr Cl ≥ 40mL/min (Cockcroft-Gault formula)
- Adequate bone marrow function:
- Platelets ≥ 100 x10 billion /L
- Hb ≥ 90g/L (no red blood cell transfusion in last 4 weeks)
- Neutrophils \> 1.5 x10 billion/L
- Adequate liver function:
- Bilirubin \< 1.5 x upper limit of normal (ULN) (or if bilirubin is between 1.5-2x ULN, must have a normal conjugated bilirubin)
- AST or ALT ≤ 2.0 x ULN (or ≤ 5.0 x ULN in the presence of liver metastases)
- Estimated life expectancy \> 12 weeks
- Study treatment both planned and able to start within 21 days of randomisation
- 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
- Signed, written informed consent
Exclusion
- Prostate cancer with significant sarcomatoid or spindle cell or neuroendocrine small cell components
- Site(s) of disease that are FDG positive with minimal PSMA expression defined as FDG intensity \> 68Ga-PSMA activity OR 68Ga-PSMA SUVmax \< 10
- Sjogren's syndrome
- Prior treatment with cabazitaxel or Lu-PSMA
- Contraindications to the use of corticosteroid treatment
- Active malignancy other than prostate cancer
- Concurrent illness, including severe infection that may jeopardise the ability of the participant to undergo the procedures outlined in this protocol with reasonable safety
- 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
- Patients who are sexually active and not willing/able to use medically acceptable forms of barrier contraception
Key Trial Info
Start Date :
January 29 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
201 Patients enrolled
Trial Details
Trial ID
NCT03392428
Start Date
January 29 2018
End Date
December 31 2021
Last Update
June 13 2022
Active Locations (11)
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1
Liverpool Hospital
Liverpool, New South Wales, Australia, 2170
2
St Vincent's Hospital
Sydney, New South Wales, Australia, 2010
3
Royal North Shore Hospital
Sydney, New South Wales, Australia, 2065
4
Calvary Mater Newcastle Hospital
Waratah, New South Wales, Australia, 2298