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

> **NCT06216249** · PHASE2 · RECRUITING · sponsor: **Jonsson Comprehensive Cancer Center** · enrollment: 90 (estimated)

## Conditions studied

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

## Interventions

- **PROCEDURE:** Computed Tomography
- **OTHER:** Gallium Ga 68 Gozetotide
- **DRUG:** Lutetium Lu 177 Vipivotide Tetraxetan
- **PROCEDURE:** Positron Emission Tomography
- **PROCEDURE:** PSMA PET Scan
- **OTHER:** Questionnaire Administration
- **PROCEDURE:** Single Photon Emission Computed Tomography

## Key facts

- **NCT ID:** NCT06216249
- **Lead sponsor:** Jonsson Comprehensive Cancer Center
- **Sponsor class:** OTHER
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2024-08-01
- **Primary completion:** 2027-12-31
- **Final completion:** 2028-12-31
- **Target enrollment:** 90 (ESTIMATED)
- **Last updated:** 2026-03-10

## Collaborators

- Novartis Pharmaceuticals

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT06216249

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT06216249, "Phase 2 Randomized Trial of Flexible Dosing Schedule of 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer (FLEX-MRT)". Retrieved via AI Analytics 2026-07-03 from https://api.ai-analytics.org/clinical/NCT06216249. Licensed CC0.

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