Re-treatment With 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer, RE-LuPSMA Trial
NCT ID: NCT06288113
Last Updated: 2025-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
40 participants
INTERVENTIONAL
2024-08-01
2027-01-27
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (177Lu-PSMA-617)
Patients receive 177Lu-PSMA-617 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 SPECT/CT on study, and undergo collection of blood samples throughout the trial.
Biospecimen Collection
Undergo collection of blood samples
Computed Tomography
Undergo PET/CT and SPECT/CT
Gallium Ga 68 Gozetotide
Given IV
Lutetium Lu 177 Vipivotide Tetraxetan
Given IV
Positron Emission Tomography
Undergo PET/CT
Questionnaire Administration
Ancillary studies
Single Photon Emission Computed Tomography
Undergo SPECT/CT
Interventions
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Biospecimen Collection
Undergo collection of blood samples
Computed Tomography
Undergo PET/CT and SPECT/CT
Gallium Ga 68 Gozetotide
Given IV
Lutetium Lu 177 Vipivotide Tetraxetan
Given IV
Positron Emission Tomography
Undergo PET/CT
Questionnaire Administration
Ancillary studies
Single Photon Emission Computed Tomography
Undergo SPECT/CT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 myelosuppressive therapy (including docetaxel, cabazitaxel, 223Ra, and 153Sm) or other radionuclide therapy within the last 6 weeks
* Patient with creatinine clearance \< 50 mL/min
MALE
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Jonsson Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Jeremie Calais, MD
Role: PRINCIPAL_INVESTIGATOR
UCLA / Jonsson Comprehensive Cancer Center
Locations
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UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NCI-2024-00310
Identifier Type: REGISTRY
Identifier Source: secondary_id
23-001509
Identifier Type: OTHER
Identifier Source: secondary_id
23-001509
Identifier Type: -
Identifier Source: org_study_id
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