Trial Title:
Phase 2 Randomized Trial of Flexible Dosing Schedule of 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer (FLEX-MRT)
NCT ID:
NCT06216249
Condition:
Prostate Carcinoma
Stage IVB Prostate Cancer American Joint Committee on Cancer (AJCC) v8
Conditions: Official terms:
Prostatic Neoplasms
Edetic Acid
1,4,7,10-tetraazacyclododecane- 1,4,7,10-tetraacetic acid
Gallium 68 PSMA-11
Pluvicto
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo PSMA PET/CT, SPECT/CT, PET/CT and CT
Arm group label:
Arm I (177Lu-PSMA-617)
Arm group label:
Arm II (177Lu-PSMA-617)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized axial tomography (procedure)
Other name:
Computerized Tomography
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Other
Intervention name:
Gallium Ga 68 Gozetotide
Description:
Given IV
Arm group label:
Arm I (177Lu-PSMA-617)
Arm group label:
Arm II (177Lu-PSMA-617)
Other name:
(68)Ga labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC
Other name:
(68)Ga-labeled Glu-urea-Lys(Ahx)-HBED-CC
Other name:
(68)Ga-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC
Other name:
(68)Gallium-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC
Other name:
(68Ga)Glu-urea-Lys(Ahx)-HBED-CC
Other name:
68Ga-DKFZ-PSMA-11
Other name:
68Ga-HBED-CC-PSMA
Other name:
68Ga-labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC
Other name:
68Ga-PSMA
Other name:
68Ga-PSMA-11
Other name:
68Ga-PSMA-HBED-CC
Other name:
[68Ga] Prostate-specific Membrane Antigen 11
Other name:
[68Ga]GaPSMA-11
Other name:
AAA 517
Other name:
AAA-517
Other name:
AAA517
Other name:
Ga PSMA
Other name:
Ga-68 labeled DKFZ-PSMA-11
Other name:
Ga-68 labeled PSMA-11
Other name:
GA-68 PSMA-11
Other name:
Gallium Ga 68 PSMA-11
Other name:
Gallium Ga 68-labeled PSMA-11
Other name:
GALLIUM GA-68 GOZETOTIDE
Other name:
Gallium-68 PSMA
Other name:
Gallium-68 PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC
Other name:
GaPSMA
Other name:
PSMA-HBED-CC GA-68
Intervention type:
Drug
Intervention name:
Lutetium Lu 177 Vipivotide Tetraxetan
Description:
Given IV
Arm group label:
Arm I (177Lu-PSMA-617)
Arm group label:
Arm II (177Lu-PSMA-617)
Other name:
177Lu-labeled PSMA-617
Other name:
177Lu-PSMA-617
Other name:
AAA 617
Other name:
AAA-617
Other name:
AAA617
Other name:
Lu177-PSMA-617
Other name:
Lutetium Lu 177-PSMA-617
Other name:
LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN
Other name:
Lutetium-177-PSMA-617
Other name:
Pluvicto
Intervention type:
Procedure
Intervention name:
Positron Emission Tomography
Description:
Undergo PET/CT
Arm group label:
Arm I (177Lu-PSMA-617)
Arm group label:
Arm II (177Lu-PSMA-617)
Other name:
Medical Imaging, Positron Emission Tomography
Other name:
PET
Other name:
PET Scan
Other name:
Positron emission tomography (procedure)
Other name:
Positron Emission Tomography Scan
Other name:
Positron-Emission Tomography
Other name:
proton magnetic resonance spectroscopic imaging
Other name:
PT
Intervention type:
Procedure
Intervention name:
PSMA PET Scan
Description:
Undergo PSMA PET/CT
Arm group label:
Arm I (177Lu-PSMA-617)
Arm group label:
Arm II (177Lu-PSMA-617)
Other name:
Prostate-specific Membrane Antigen PET
Other name:
PSMA PET
Other name:
PSMA-Positron emission tomography
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Arm I (177Lu-PSMA-617)
Arm group label:
Arm II (177Lu-PSMA-617)
Intervention type:
Procedure
Intervention name:
Single Photon Emission Computed Tomography
Description:
Undergo SPECT/CT
Arm group label:
Arm I (177Lu-PSMA-617)
Arm group label:
Arm II (177Lu-PSMA-617)
Other name:
Medical Imaging, Single Photon Emission Computed Tomography
Other name:
Single Photon Emission Tomography
Other name:
Single-Photon Emission Computed
Other name:
single-photon emission computed tomography
Other name:
SPECT
Other name:
SPECT imaging
Other name:
SPECT SCAN
Other name:
SPET
Other name:
ST
Other name:
tomography, emission computed, single photon
Other name:
Tomography, Emission-Computed, Single-Photon
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.
Detailed description:
PRIMARY OBJECTIVE:
I. To assess a potential survival benefit (2-year survival rate) of patients treated with
Lu 177 vipivotide tetraxetan (177Lu-PSMA-617) therapy on a flexible dosing schedule
including up to 12 cycles and potential "treatment holiday" periods in comparison to
patients treated with the standard fixed dosing schedule of maximum 6 treatment cycles
every 6 weeks.
SECONDARY OBJECTIVES:
I. To determine the safety of the flexible/extended schedule of 177Lu-PSMA-617 therapy.
II. To compare the overall survival (OS) of the flexible/extended schedule of
177Lu-PSMA-617 therapy to the standard-of-care schedule of 177Lu-PSMA-617 therapy.
III. To compare the progression-free survival (PFS) of the flexible/extended schedule of
177Lu-PSMA-617 therapy to the standard-of-care schedule of 177Lu-PSMA-617 therapy.
IV. To compare the disease control rate (DCR) of the flexible/extended schedule of
177Lu-PSMA-617 therapy to the standard-of-care schedule of 177Lu-PSMA-617 therapy.
V. To compare the impact on bone pain level of the flexible/extended schedule of
177Lu-PSMA-617 therapy to the standard-of-care schedule of 177Lu-PSMA-617 therapy.
VI. To compare the impact on health-related quality of life of the flexible/extended
schedule of 177Lu-PSMA-617 therapy to the standard-of-care schedule of 177Lu-PSMA-617
therapy.
EXPLORATORY OBJECTIVE:
I. To determine the dosimetry in organs and tumor lesions of the flexible/extended
schedule of 177Lu-PSMA-617 therapy.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive 177Lu-PSMA-617 intravenously (IV) once every 6 weeks on study.
Beginning with the third cycle, treatments may be postponed beyond the 6 weeks interval
based on defined response criteria ("treatment holiday" period). Treatment repeats every
6 weeks for 12 cycles in the absence of disease progression or unacceptable toxicity.
Patients receive gallium Ga 68 gozetotide (68Ga-PSMA-11) IV and undergo prostate-specific
membrane antigen positron emission tomography/computed tomography (PSMA PET/CT)
throughout the trial. Patients also undergo single photon emission computed tomography
(SPECT)/CT, PET/CT, or CT on the trial.
ARM II: Patients receive 177Lu-PSMA-617 IV once every 6 weeks on study. Treatment repeats
every 6 weeks for 6 cycles in the absence of disease progression or unacceptable
toxicity. Patients receive 68Ga-PSMA-11 IV and undergo PSMA PET/CT throughout the trial.
Patients also undergo SPECT/CT, PET/CT, or CT on the trial.
Upon completion of study treatment, patients are followed up every 3 months for 24 months
from after first cycle of study treatment.
Criteria for eligibility:
Criteria:
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
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
UCLA / Jonsson Comprehensive Cancer Center
Address:
City:
Los Angeles
Zip:
90095
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jeremie Calais
Phone:
213-769-9636
Email:
jcalais@mednet.ucla.edu
Investigator:
Last name:
Jeremie Calais
Email:
Principal Investigator
Start date:
August 1, 2024
Completion date:
December 31, 2028
Lead sponsor:
Agency:
Jonsson Comprehensive Cancer Center
Agency class:
Other
Source:
Jonsson Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06216249
