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Phase 2 Study of Flexible Dosing for 177Lu-PSMA-617 in Prostate Cancer

This study is testing a new way to give a treatment called Lutetium Lu 177 Vipivotide Tetraxetan (177Lu-PSMA-617) for metastatic castration-resistant prostate cancer (mCRPC). This treatment is a targeted therapy, meaning it aims to attack cancer cells specifically. Currently, 177Lu-PSMA-617 is given on a fixed schedule. This study wants to see if a flexible schedule, which could include more cycles or breaks from treatment, works better than the standard schedule. You might be able to join if you are a man aged 18 or older with prostate cancer that has spread, and you have already had certain other treatments. The main goal is to see if the flexible schedule improves how long people live after 2 years. The study is currently recruiting about 90 participants, but its overall status is unclear.

Study design
This is a randomized study, meaning participants will be assigned by chance to receive either the standard treatment schedule or the flexible schedule. It aims to enroll 90 participants.
What's involved
You would undergo various imaging procedures, including PSMA PET/CT, SPECT/CT, PET/CT, and CT scans. You would also receive the study drug, Lutetium Lu 177 Vipivotide Tetraxetan, intravenously (IV).
Compensation
Not stated in the trial record.
Follow-up
Your survival will be measured for up to 2 years from the date of your first treatment cycle.

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NCT06216249

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Jonsson Comprehensive Cancer Center
~90 participants
Updated 2026-03-10 on ClinicalTrials.gov
What's tested:Computed TomographyGallium Ga 68 GozetotideLutetium Lu 177 Vipivotide TetraxetanPositron Emission TomographyPSMA PET ScanQuestionnaire Administration

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
2-year survival rate
Measured over From the date of the first cycle of Lu 177 vipivotide tetraxetan (177Lu-prostate-specific membrane antigen [PSMA]-617) therapy, up to 2 years

Conditions

Prostate Carcinoma
Stage IVB Prostate Cancer American Joint Committee on Cancer (AJCC) v8

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Jeremie Calais · PRINCIPAL_INVESTIGATOR · UCLA / Jonsson Comprehensive Cancer Center

Who to contact

Stephanie Lira
[email protected]
310-206-0596
Email the study team

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Do you actually qualify for this trial?

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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

What this trial measures

  • 2-year survival rateFrom the date of the first cycle of Lu 177 vipivotide tetraxetan (177Lu-prostate-specific membrane antigen [PSMA]-617) therapy, up to 2 years

    Will be assessed patients treated with 177Lu-PSMA-617 therapy on a flexible dosing schedule (investigational arm) in comparison to patients treated with the standard fixed dosing schedule of maximum 6 treatments cycles every 6 weeks (control arm). Will be reported using descriptive statistics by means of number and percentage of patients dead 24 months after the first cycle.