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This clinical trial will evaluate the safety of Cabazitaxel in combination with 177Lu-PSMA-617 in metastatic castration-resistant prostate cancer.
Full 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 metastatic castration-resistant prostate cancer (mCRPC).
This study aims to assess and establish the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), and recommended phase 2 dose (RP2D) of cabazitaxel in combination with 177Lu-PSMA-617 in patients with mCRPC.
32-44 men with mCRPC who have progressed on prior docetaxel and a second-generation AR antagonist will be enrolled in this trial in two stages: dose escalation and a dose expansion phase over a period of 18 months.
Enrollment
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Volunteers
Inclusion criteria
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:
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:
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 criteria
Primary purpose
Allocation
Interventional model
Masking
44 participants in 1 patient group
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Central trial contact
Gaurav Sharma; Dr Louise Kostos
Data sourced from clinicaltrials.gov
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