Status:
RECRUITING
Phase 2 Randomized Trial of Flexible Dosing Schedule of 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer (FLEX-MRT)
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Collaborating Sponsors:
Novartis Pharmaceuticals
Conditions:
Prostate Carcinoma
Stage IVB Prostate Cancer American Joint Committee on Cancer (AJCC) v8
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
In advanced metastatic castration resistant prostate cancer (mCRPC) progressing after chemotherapy and androgen receptor (AR)-targeted therapy 177Lu-PSMA-617 is an effective treatment. 177Lu-PSMA-617 ...
Detailed Description
PRIMARY OBJECTIVE: I. To assess a potential survival benefit (2-year survival rate) of patients treated with Lu 177 vipivotide tetraxetan (177Lu-PSMA-617) therapy on a flexible dosing schedule includ...
Eligibility Criteria
Inclusion
- Patients must have prostate cancer proven by histopathology
- Patients must have ≥ 1 metastatic lesion by any imaging (CT, magnetic resonance imaging \[MRI\], bone scan, PET)
- Patients must have received at least one regimen of chemotherapy for mCRPC
- Patients must have received at least one androgen-receptor signaling inhibitors (ARSI)
- Patients must be eligible by PSMA PET VISION criteria. PSMA PET/CT must be performed within 8 weeks of planned first cycle of 177Lu-PSMA-617
- White blood cell (WBC) ≥ 2,500/ul
- Platelets (PLT) ≥ 100,000/ul
- Hemoglobin (Hb) ≥ 9.0 g/dl
- Absolute neutrophil count (ANC) ≥ 1,500 ul
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Patients must be adults ≥ 18 years of age
- Patients must have the ability to understand and sign an approved informed consent form (ICF)
- Patients must have the ability to understand and comply with all protocol requirements
Exclusion
- Prior cycle of 177Lu-PSMA-617 therapy
- Less than 6 weeks between last myelosuppressive therapy (including docetaxel, cabazitaxel, strontium-89, samarium-153, rhenium-186, rhenium-188, radium-223, hemi-body irradiation) and first cycle of 177Lu-PSMA-617 therapy
- Glomerular filtration rate (GFR) \< 50 ml/min
- Urinary tract obstruction or marked hydronephrosis
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06216249
Start Date
August 1 2024
End Date
December 31 2028
Last Update
February 26 2025
Active Locations (1)
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1
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095