Status:
ACTIVE_NOT_RECRUITING
Cabazitaxel in Combination With 177Lu-PSMA-617 in Metastatic Castration-resistant Prostate Cancer
Lead Sponsor:
Peter MacCallum Cancer Centre, Australia
Conditions:
Metastatic Castration-resistant Prostate Cancer
mCRPC
Eligibility:
MALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This clinical trial will evaluate the safety of Cabazitaxel in combination with 177Lu-PSMA-617 in metastatic castration-resistant prostate cancer.
Detailed Description
This prospective, single-centre, single-arm, open label, phase I/II trial will assess the safety, efficacy and anti-tumour activity of cabazitaxel in combination with 177Lu-PSMA-617 in patients with m...
Eligibility Criteria
Inclusion
- Male patients aged 18 years or older at the time of informed consent.
- Patient has provided written informed consent.
- Histologically confirmed adenocarcinoma of the prostate without neuroendocrine or small cell differentiation.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
- Patients must have had prior treatment with docetaxel.
- Patients must have progressed on a second-generation androgen receptor (AR)-targeted agent (e.g., enzalutamide, abiraterone, or apalutamide) in the castrate-resistant setting.
- Patients must have progressive disease. The Prostate Cancer Clinical Trials Working Group 3 (PCWG3) defines this as any one of the following:
- PSA progression: minimum of two rising PSA values from a baseline measurement with an interval of ≥ 1 week between each measurement
- Soft tissue or visceral disease progression as per Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1) criteria
- Bone progression: ≥ 2 new lesions on bone scan
- At least three weeks since the completion of surgery prior to registration.
- Prior surgical orchiectomy or chemical castration maintained on luteinizing hormone-releasing hormone (LHRH) analogue (agonist or antagonist).
- Serum testosterone levels ≤ 1.75nmol/L within 28 days prior to registration.
- Imaging evidence of metastatic disease documented with either whole body bone scan (WBBS) or computed tomography (CT) scan performed within 28 days prior to registration.
- Significant prostate-specific membrane antigen (PSMA) avidity on PSMA PET/CT, defined as a minimum uptake of SUVmax 15 at a site of disease.
- Patients must have a life expectancy ≥ 12 weeks.
- Assessed by a medical oncologist as suitable for treatment with cabazitaxel and 177Lu-PSMA-617.
- Patients must have adequate bone marrow, hepatic and renal function documented within 28 days prior to registration, defined as:
- Haemoglobin ≥ 90 g/L independent of transfusions (no red blood cell transfusion in last 28 days prior to registration)
- Absolute neutrophil count (ANC) ≥ 1.5x10\^9/L
- Platelets ≥ 150 x10\^9/L
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN) except for patients with known Gilbert's syndrome, where this applies for the unconjugated bilirubin component
- Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN if there is no evidence of liver metastasis or ≤ 5 x ULN in the presence of liver metastases
- Albumin ≥ 25 g/L
- Adequate renal function: patients must have a creatinine clearance estimated of ≥ 40 mL/min using the Cockcroft-Gault equation
- Sexually active patients are willing to use medically acceptable forms of barrier contraception.
- Willing and able to comply with all study requirements, including all treatments and the timing and nature of all required assessments.
Exclusion
- Superscan on WBBS or diffuse marrow disease on PSMA PET.
- Site(s) of measurable disease that are FDG-positive with low PSMA expression (SUVmax \<10).
- Prior treatment with cabazitaxel or 177Lu-PSMA-617.
- Contraindications to the use of corticosteroid treatment.
- Other malignancies within the previous 2-years other than basal cell or squamous cell carcinomas of skin or other cancers that are unlikely to recur within 24 months.
- Presence of untreated brain metastases or leptomeningeal metastases.
- Patients with symptomatic or impending cord compression unless appropriately treated beforehand and clinically stable for ≥ four weeks.
- Concurrent illness, including severe infection that may jeopardise the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety.
- Persistent toxicities (CTCAE v5.0 \>/= Grade 2) caused by previous cancer therapy, excluding alopecia.
- Known HIV or hepatitis B or C infection.
- Radiotherapy or systemic anti-cancer therapies administered within 14 days prior to registration, excluding androgen deprivation therapy (ADT).
Key Trial Info
Start Date :
July 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2026
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT05340374
Start Date
July 14 2022
End Date
December 1 2026
Last Update
April 6 2025
Active Locations (2)
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1
St Vincent's Hospital
Sydney, New South Wales, Australia, 2000
2
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3000