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

Summary

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.

Conditions

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

Interventions

PROCEDURE

Computed Tomography

Undergo PSMA PET/CT, SPECT/CT, PET/CT and CT

OTHER

Gallium Ga 68 Gozetotide

Given IV

DRUG

Lutetium Lu 177 Vipivotide Tetraxetan

Given IV

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

PROCEDURE

PSMA PET Scan

Undergo PSMA PET/CT

OTHER

Questionnaire Administration

Ancillary studies

PROCEDURE

Single Photon Emission Computed Tomography

Undergo SPECT/CT

Sponsors & Collaborators

• Novartis Pharmaceuticals

  collaborator INDUSTRY

• Jonsson Comprehensive Cancer Center

  lead OTHER

Principal Investigators

• Jeremie Calais · UCLA / Jonsson Comprehensive Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-08-01

Primary Completion

2027-12-31

Completion

2028-12-31

FDA Device

Yes

Countries

• United States

Study Locations