Alpha-Emitting Radionuclide or Beta-Emitting Radionuclide With Metastasis-Directed Stereotactic Body Radiotherapy for the Treatment of Recurrent, Oligometastatic Prostate Adenocarcinoma
NCT ID: NCT07150715
Last Updated: 2025-12-17
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
107 participants
INTERVENTIONAL
2025-12-12
2031-10-31
Brief Summary
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Detailed Description
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I. To assess progression-free survival for men with oligorecurrent prostate cancer after stereotactic body radiotherapy (SBRT) in combination with 2 cycles of Lutetium Lu 177 Vipivotide Tetraxetan (177Lu-PSMA-617) versus SBRT in combination with 1 cycle of Actinium Ac 225 Vipivotide Tetraxetan (225Ac-PSMA-617), with progression defined on the basis of prostate specific membrane antigen (PSMA) positron emission tomography (PET)/computed tomography (CT) scans obtained at 24 months post-SBRT or at the time of prostate specific antigen (PSA)-based biochemical progression, initiation of salvage therapy or death.
SECONDARY OBJECTIVES:
I. To evaluate burden of disease (including local control of irradiated lesions and presence of other disease) on a PSMA PET/CT obtained 24 months after SBRT + 177Lu-PSMA-617 versus SBRT + 225Ac-PSMA-617 in patients with oligometastatic disease who have not progressed by that point.
II. To assess physician-scored toxicity (common terminology criteria for adverse events \[CTCAE\] version 5.0) of SBRT + 177Lu-PSMA-617 versus SBRT + 225Ac-PSMA-617 in patients with oligometastatic disease.
III. To assess patient-reported quality of life (based on the Xerostomia Inventory scale) after SBRT + 177Lu-PSMA-617 versus SBRT + 225Ac-PSMA-617 in patients with oligometastatic disease.
IV. To assess androgen deprivation therapy (ADT)-free survival after 177Lu-PSMA-617 versus SBRT + 225Ac-PSMA-617 in patients with oligometastatic disease.
V. To determine local control of irradiated lesions at 24 months after last radionuclide infusion in patients with oligometastatic disease (based on a scheduled PSMA-PET), comparing 177Lu-PSMA-617 versus SBRT + 225Ac-PSMA-617.
VI. To assess time to locoregional progression, time to distant progression, time to new metastasis, and duration of response after last radionuclide infusion in patients with oligometastatic disease (as defined by PSMA PET/CT).
CORRELATIVE OBJECTIVES:
I. To quantitatively sequence T-cell receptor (TCR) repertoires using peripheral blood monocytes at baseline, 3 months, 6 months, and 12 months after last infusion of radionuclide.
II. To perform radiomics analysis on PSMA PET/CT scans performed at 24 months after last infusion of radionuclide, or at time of progression.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive 177Lu-PSMA-617 intravenously (IV) over 1-10 minutes on day one of each cycle. Cycles repeat every 6 weeks for 2 cycles. 4-6 weeks after completion of 177Lu-PSMA-617 patients receive Gallium Ga 68 Gozetotide (68Ga-PSMA-11) IV and undergo PSMA PET/CT scan. Within 4 weeks of the scan, patients receive SBRT for 1-5 treatments over 1- 1- days. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo PSMA PET/CT scan and blood sample collection throughout the study.
ARM II: Patients receive 225Ac-PSMA-617 IV once. 4-6 weeks after completion of 225Ac-PSMA-617 patients receive 68Ga-PSMA-11 IV and undergo PSMA PET/CT scan. Within 4 weeks of the scan, patients receive SBRT for 1-5 treatments, over 1- 1- days. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo PSMA PET/CT scan and blood sample collection throughout the study.
After completion of study treatment, patients are followed up every 3 months for 2 years and at 60 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm I (177Lu-PSMA-617)
Patients receive 177Lu-PSMA-617 IV, over 1-10 minutes, on day one of each cycle. Cycles repeat every 6 weeks for 2 cycles. 4-6 weeks after completion of 177Lu-PSMA-617 patients receive 68Ga-PSMA-11 IV and undergo PSMA PET/CT scan. Within 4 weeks of the scan, patients receive SBRT, for 1-5 treatments, over 1- 1- days. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo PSMA PET/CT scan and blood sample collection throughout the study.
Actinium Ac 225 Vipivotide Tetraxetan
Given IV
Biospecimen Collection
Undergo blood sample collection
Lutetium Lu 177 Vipivotide Tetraxetan
Given IV
PSMA PET-CT Scan
Undergo PSMA PET/CT scan
Stereotactic Body Radiation Therapy
Undergo SBRT
Arm II (225Ac-PSMA-617)
Patients receive 225Ac-PSMA-617 IV once. 4-6 weeks after completion of 225Ac-PSMA-617 patients receive 68Ga-PSMA-11 IV and undergo PSMA PET/CT scan. Within 4 weeks of the scan, patients receive SBRT, for 1-5 treatments, over 1- 1- days. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo PSMA PET/CT scan and blood sample collection throughout the study.
Actinium Ac 225 Vipivotide Tetraxetan
Given IV
Biospecimen Collection
Undergo blood sample collection
Gallium Ga 68 Gozetotide
Given IV
PSMA PET-CT Scan
Undergo PSMA PET/CT scan
Stereotactic Body Radiation Therapy
Undergo SBRT
Interventions
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Actinium Ac 225 Vipivotide Tetraxetan
Given IV
Biospecimen Collection
Undergo blood sample collection
Gallium Ga 68 Gozetotide
Given IV
Lutetium Lu 177 Vipivotide Tetraxetan
Given IV
PSMA PET-CT Scan
Undergo PSMA PET/CT scan
Stereotactic Body Radiation Therapy
Undergo SBRT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Serum testosterone \> 150 ng/dL
* Age ≥ 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* No indication for urgent or emergent radiation
* Histological confirmation of prostate adenocarcinoma (histology from original treatment acceptable)
* White blood cell count ≥ 2.5 × 109/L
* Platelets ≥ 100 × 109/L
* Hemoglobin ≥ 9 g/dL
* Total bilirubin ≤ 1.5 × institutional upper limits of normal (ULN) or up to 3 × ULN if known history of Gilbert's syndrome
* Alanine aminotransferase or aspartate aminotransferase ≤ 3.0 × ULN or ≤ 5.0 × ULN for patients with liver metastases
* Glomerular filtration rate creatinine-cystatin C (GFRcr-cys) ≥ 60 mL/min 1.73m2 using the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) 2021 equation
* Serum albumin \> 3.0 g/dL
* Partner and patient must use a method of birth control with adequate barrier protection, deemed acceptable by the principal investigator during the study and for 3 months after last study drug administration
* Ability to understand, and willingness to sign, the written informed consent
Exclusion Criteria
* Patients with castrate-resistant disease (i.e., prostate specific antigen \[PSA\] \> 0.5 ng/mL with serum testosterone \<150 ng/dL)
* Patients who received androgen deprivation therapy or cytotoxic chemotherapy within 6 months of trial enrolment
* Concurrent systemic therapy for a solid organ malignancy
* Spinal cord compression
* Inability to lie flat
* Known hypersensitivity to components of 177-Lu-PSMA-617 or 225-Ac-Lu-PSMA-617
* Inadequate renal function of GFRcr-cys \< 60 mL/min 1.73m2 using the CKD-EPI 2021equation
* Total bilirubin \> 1.5 × ULN or \> 3.0 × ULN if known history of Gilbert's syndrome
* Alanine aminotransferase or aspartate aminotransferase \> 3 × ULN (or 5 × ULN for patients with known liver metastases)
* De novo oligometastatic disease
18 Years
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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Amar Kishan
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-2025-05583
Identifier Type: REGISTRY
Identifier Source: secondary_id
25-1338
Identifier Type: -
Identifier Source: org_study_id