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

About

Brief Summary

The randomized phase 2 FLEX MRT compares a group of patients treated with LuPSMA on a flexible and extended dosing schedule including "treatment holiday" periods (investigational arm, up to 12 cycles) to a control group treated with a fixed dosing schedule of 6 treatments cycles maximum administered every 6 weeks.

The flexible dosing schedule in the investigational arm, will be based on SPECT/CT response assessments obtained 24h after injection of LuPSMA therapy cycle. The response assessment during treatment holiday period will be based on PET/CT every 12 weeks.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 2

Eligibility

Gender

Male

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

N/A

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) ≥ 1500/ul
Platelets (PLT) ≥ 50.000/ul
Hemoglobin (Hb) ≥ 8.0 g/dl
Absolute neutrophil count (ANC) ≥ 1000 mm^3
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 of 177Lu-PSMA-617 therapy
Less than 6 weeks since last myelosuppressive therapy (including docetaxel, cabazitaxel, strontium-89, samarium-153, rhenium-186, rhenium-188, radium-223, hemi-body irradiation)
Glomerular filtration rate (GFR) < 30 ml/min
Urinary tract obstruction or marked hydronephrosis

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