A Phase 2 Randomized Trial in Patients With Metastatic Castration Resistant Prostate Cancer to Determine the Efficacy of a Flexible Dosing Schedule of Lu-PSMA Treatment up to 12 Cycles Including Potential Treatment Holiday Periods in Comparison to the Standard Fixed Dosing Schedule of Six Cycles Every Six Weeks (FLEX-MRT)
Condition: Prostate Carcinoma, Stage IVB Prostate Cancer American Joint Committee on Cancer (AJCC) v8
Study Type: Interventional
Clinical Trials Identifier NCT 8-digits: NCT06216249
Sponsor: Jonsson Comprehensive Cancer Center
Phase: Phase 2
Eligibility:
- Age: minimum 18 Years maximum N/A
- Gender: Male
Inclusion Criteria:
- 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 Criteria:
- 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
View trial on ClinicalTrials.gov