Trial Title:
Re-treatment With 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer, RE-LuPSMA Trial
NCT ID:
NCT06288113
Condition:
Castration-Resistant Prostate Carcinoma
Stage IVB Prostate 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:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo collection of blood samples
Arm group label:
Treatment (177Lu-PSMA-617)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo PET/CT and SPECT/CT
Arm group label:
Treatment (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:
Treatment (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:
Treatment (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:
Treatment (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:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Treatment (177Lu-PSMA-617)
Intervention type:
Procedure
Intervention name:
Single Photon Emission Computed Tomography
Description:
Undergo SPECT/CT
Arm group label:
Treatment (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:
This phase II trial tests how well re-treatment with 177Lu-PSMA-617 works in treating
patients with prostate cancer that has spread from where it first started (primary site)
to other places in the body (metastatic), that continues to grow or spread after the
surgical removal of the testes or medical treatment to block androgen production
(castration-resistant), and that has shown a favorable response to initial treatment with
177Lu-PSMA-617. 177Lu-PSMA-617 is a radioactive drug. It binds to a protein called
prostate specific membrane antigen (PSMA), which is expressed by some types of prostate
tumor cells. When 177Lu-PSMA-617 binds to PSMA-expressing tumor cells, it delivers
radiation to the cells, which may kill them. Re-treatment with 177Lu-PSMA-617 in patients
who had a favorable response to initial 177Lu-PSMA-617 treatment may improve survival
outcomes and disease response in patients with metastatic castration-resistant prostate
cancer.
Detailed description:
PRIMARY OBJECTIVE:
I. To assess the treatment efficacy of re-challenge lutetium Lu 177 vipivotide tetraxetan
(177Lu-PSMA-617) therapy (for a maximum of 6 additional cycles) in patients with
metastatic castration-resistant prostate cancer (mCRPC) who had a favorable response to a
prior regimen of 177Lu-PSMA-617 therapy.
SECONDARY OBJECTIVES:
I. To determine the safety of re-challenge 177Lu-PSMA-617 therapy by Common Terminology
Criteria for Adverse Events (CTCAE), version 5.0.
II. To determine the rate of patients who have a prostate-specific antigen (PSA) response
(defined as a PSA decline of ≥ 50% during re-challenge 177Lu-PSMA-617 therapy).
III. To determine biochemical progression-free survival (PFS) according to Prostate
Cancer Working Group 3 (PCWG3) guidelines.
IV. To determine overall survival (OS) from the start (cycle 1 day 1) of the first
regimen of 177Lu-PSMA-617 therapy.
V. To determine OS from the end (day 1 of the final cycle) of the first regimen of
177Lu-PSMA-617 therapy.
VI. To determine radiographic progression-free survival (rPFS) according to Response
Evaluation Criteria in PSMA positron emission tomography (PET)/computed tomography (CT)
(RECIP) criteria.
VII. To determine the impact of re-challenge 177Lu-PSMA-617 therapy on bone pain level,
health-related quality of life, and performance status (Eastern Cooperative Oncology
Group [ECOG]) using established standardized questionnaires.
EXPLORATORY OBJECTIVE:
I. To determine the dosimetry in organs and tumor lesions of re-challenge 177Lu-PSMA-617
therapy using a 24-hour single-time-point dosimetry protocol.
OUTLINE:
Patients receive 177Lu-PSMA-617 intravenously (IV) on day 1 of each cycle. Treatment
repeats every 6 weeks for up to 6 cycles in the absence of disease progression or
unacceptable toxicity. Patients also receive gallium Ga 68 gozetotide IV and undergo
PET/CT at screening and on study, undergo single photon emission computed tomography
(SPECT)/CT on study, and undergo collection of blood samples throughout the trial.
After completion of study treatment, patients are followed up within 8 weeks of their
last treatment cycle and then every 3 months for up to a total of 2 years.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients must have mCRPC
- Patients must have received at least one regimen of chemotherapy for mCRPC
- Patients must have received at least one androgen receptor signaling inhibitor
(ARSI)
- Patients must have previously completed at least 4 cycles of 177Lu-PSMA-617 therapy
- Patients must have had a favorable response to the first regimen of 177Lu-PSMA-617
therapy defined as:
- PSA decline of ≥ 50% at any time during the first regimen of 177Lu-PSMA-617
therapy AND
- No new prostate cancer therapy within two months of completing the first
regimen of 177Lu-PSMA-617 therapy (first-generation androgen deprivation
therapy [ADT] is allowed). Concomitant prostate cancer therapy that was
administrated during the first regimen of 177Lu-PSMA-617 therapy and continued
afterwards is allowed
- Patients must have had a PSA increase after the first regimen of 177Lu-PSMA-617
therapy, confirmed by a second measurement ≥ 3 weeks apart
- Patients must meet PSMA PET/CT VISION criteria. PSMA PET/CT must have been completed
within 8 weeks of the planned first cycle of re-challenge 177Lu-PSMA-617 therapy and
at least 6 weeks after completion of the first regimen of 177Lu-PSMA-617 therapy
- White blood cells > 2,500 cells/µL
- Absolute neutrophil count > 1,500 cells/µL
- Hemoglobin > 9.0 g/dL
- Platelets > 100,000 cells/µL
- Patients must have the ability to understand and sign an approved informed consent
form (ICF) and comply with all protocol requirements
Exclusion Criteria:
- Patient received new prostate cancer therapy within two months of completing the
first regimen of 177Lu-PSMA-617 therapy (first-generation ADT (adenosine
triphosphate) is allowed). This can include apalutamide, enzalutamide, abiraterone,
chemotherapy, immunotherapy, radionuclide therapy, PARP inhibitor, or any biological
therapy. Concomitant prostate cancer therapy that was administrated during the first
regimen of 177Lu-PSMA-617 therapy and continued afterwards is allowed
- Patient received myelosuppressive therapy (including docetaxel, cabazitaxel, 223Ra,
and 153Sm) or other radionuclide therapy within the last 6 weeks
- Patient with creatinine clearance < 50 mL/min
Gender:
Male
Minimum age:
N/A
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:
Ethan Lam
Phone:
310-206-7372
Email:
clam@mednet.ucla.edu
Contact backup:
Last name:
Stephanie Lira
Phone:
3102060596
Email:
StephanieLira@mednet.ucla.edu
Investigator:
Last name:
Jeremie Calais
Email:
Principal Investigator
Start date:
August 1, 2024
Completion date:
January 27, 2027
Lead sponsor:
Agency:
Jonsson Comprehensive Cancer Center
Agency class:
Other
Collaborator:
Agency:
Novartis Pharmaceuticals
Agency class:
Industry
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/NCT06288113
