Alpha-Emitting Radionuclide or Beta-Emitting Radionuclide With Metastasis-Directed Stereotactic Body Radiotherapy for the Treatment of Recurrent, Oligometastatic Prostate Adenocarcinoma
ANDROMEDA
2 other identifiers
interventional
107
1 country
1
Brief Summary
This phase II trial compares the use of 225Ac-PSMA-617 to 177Lu-PSMA-617, along with stereotactic body radiotherapy for the treatment of prostate cancer that has come back after a period of improvement (recurrent) and that has spread from where it first started (primary site) to multiple other places in the body (oligometastatic). 225Ac-PSMA-617 and 177Lu-PSMA-617 are radioactive drugs. They bind to a protein called a PSMA receptor, which is found on some prostate tumor cells. 225Ac-PSMA-617 or 177Lu-PSMA-617 builds up in these cells and gives off either alpha or beta radiation that may kill them. It is a type of radioconjugate and a type of PSMA analog. Stereotactic body radiation therapy (SBRT) is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Giving 225Ac-PSMA-617 or 177Lu-PSMA-617 and metastasis directed stereotactic body radiotherapy may be effective in treating patients with recurrent, oligometastatic prostate cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2025
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2025
CompletedFirst Posted
Study publicly available on registry
September 2, 2025
CompletedStudy Start
First participant enrolled
December 12, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 31, 2031
December 17, 2025
December 1, 2025
4.9 years
August 25, 2025
December 15, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Progression free survival (PFS)
A progression event will be based on prostate specific membrane antigen positron emission tomography/ computed tomography findings triggered either by a prostate specific antigen rise or at the timepoint defined by 24 months measured from the final radionuclide infusion (i.e., second infusion of 177Lu-PSMA-617 and first infusion of 225Ac-PSMA-617). The Kaplan-Meier (KM) method will be used to summarize PFS and log-rank test will be used to compare PFS between the two arms.
From the date of randomization to the date of disease progression or death, whichever happens earlier, up to 5 years
Secondary Outcomes (8)
Incidence of adverse events (AEs)
From time of randomization, up to 5 years
Androgen deprivation therapy free survival
Up to 5 years
Time to locoregional progression
Up to 5 years
Time to new metastasis
Up to 5 years
Overall survival
Up to 5 years
- +3 more secondary outcomes
Study Arms (2)
Arm I (177Lu-PSMA-617)
EXPERIMENTALPatients 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.
Arm II (225Ac-PSMA-617)
EXPERIMENTALPatients 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.
Interventions
Undergo blood sample collection
Given IV
Given IV
Undergo PSMA PET/CT scan
Undergo SBRT
Given IV
Eligibility Criteria
You may qualify if:
- Oligorecurrent prostate cancer as determined by the presence of 1-5 asymptomatic lesions outside the prostate or prostate bed identified on PSMA PET/CT by local readers
- 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
You may not qualify if:
- Patients with neuroendocrine or small cell carcinoma of the prostate
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jonsson Comprehensive Cancer Centerlead
- Novartis Pharmaceuticalscollaborator
Study Sites (1)
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amar Kishan
UCLA / Jonsson Comprehensive Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2025
First Posted
September 2, 2025
Study Start
December 12, 2025
Primary Completion (Estimated)
October 31, 2030
Study Completion (Estimated)
October 31, 2031
Last Updated
December 17, 2025
Record last verified: 2025-12