Phase 2 Randomized Trial of Flexible Dosing Schedule of 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer (FLEX-MRT)

Launched by JONSSON COMPREHENSIVE CANCER CENTER · Jan 10, 2024

Keywords

ClinConnect Summary

The FLEX-MRT clinical trial is studying a new treatment approach for men with advanced prostate cancer that has not responded to hormone therapy. This trial compares two groups: one group will receive a flexible treatment schedule of a drug called 177Lu-PSMA-617, which allows for breaks in treatment based on how well the cancer is responding, while the other group will follow a standard treatment schedule of six fixed doses given every six weeks. The goal is to see if the flexible schedule can help manage the cancer more effectively while also being easier for patients.

To be eligible for this trial, participants must be adult men diagnosed with prostate cancer that has spread to other parts of the body. They should have already undergone at least one round of chemotherapy and one treatment that targets hormone receptors. Additionally, they should have a specific type of imaging done to confirm their cancer's status. Throughout the trial, participants will undergo regular scans to monitor how well the treatment is working. This study is currently recruiting participants, and it's important for those interested to fully understand the trial details and requirements before deciding to join.

Gender

MALE

Eligibility criteria

• 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