OncoMatch/Clinical Trials/NCT06216249
Phase 2 Randomized Trial of Flexible Dosing Schedule of 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer (FLEX-MRT)
Is NCT06216249 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Lutetium Lu 177 Vipivotide Tetraxetan for prostate carcinoma.
Treatment: Lutetium Lu 177 Vipivotide Tetraxetan — 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 RLT is administered with a fixed schedule: 6 treatment cycles, administered every 6 weeks. However, the optimum number of cycles of 177Lu-PSMA in patients who show good response remains unknown. Some patients may benefit from more than 6 cycles of therapy. Additionally, some patients experience a complete or almost complete response before the last cycle. It is unclear whether these patients benefit from the subsequent remaining treatment cycle(s). A treatment holiday period would spare these patients some exposure to the therapy agent and avoid potentially unnecessary toxicity when treatment efficacy is already maximal and additional treatment effect cannot be expected. This randomized phase 2 study 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, as described below) 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 single photon emission computed tomography (SPECT)/computed tomography (CT) response assessments obtained 24h after injection of LuPSMA therapy cycle. The response assessment during treatment holiday period will be based on positron emission tomography/computed tomography (PET/CT) every 12 weeks. Single-time point SPECT/CT dosimetry protocol at every cycle will be performed and will allow to determine the number of cycles that subjects may receive under the study without exceeding the kidney dose threshold.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Biomarker criteria
Required: FOLH1 PSMA PET VISION criteria
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
Disease stage
Required: Stage IVB (AJCC v8)
Metastatic disease required
Stage IVB Prostate Cancer American Joint Committee on Cancer (AJCC) v8
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: chemotherapy — for mCRPC
Patients must have received at least one regimen of chemotherapy for mCRPC
Must have received: androgen-receptor signaling inhibitor
Patients must have received at least one androgen-receptor signaling inhibitors (ARSI)
Cannot have received: 177Lu-PSMA-617 (177Lu-PSMA-617)
Prior cycle of 177Lu-PSMA-617 therapy
Lab requirements
Blood counts
WBC ≥ 2,500/ul; Platelets ≥ 100,000/ul; Hemoglobin ≥ 9.0 g/dl; ANC ≥ 1,500/ul
Kidney function
Glomerular filtration rate (GFR) ≥ 50 ml/min
WBC ≥ 2,500/ul; Platelets ≥ 100,000/ul; Hemoglobin ≥ 9.0 g/dl; ANC ≥ 1,500/ul; Glomerular filtration rate (GFR) < 50 ml/min [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UCLA / Jonsson Comprehensive Cancer Center · Los Angeles, California
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