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Recurrent, Oligometastatic Prostate Cancer Treatment Study

This study is for men with prostate cancer that has returned (recurrent) and spread to a few other places in the body (oligometastatic). It compares two radioactive drugs, Actinium Ac 225 Vipivotide Tetraxetan and Lutetium Lu 177 Vipivotide Tetraxetan, when given with stereotactic body radiotherapy. These drugs target a protein called PSMA found on prostate cancer cells, delivering radiation to potentially kill them. The main goal is to see which treatment helps patients live longer without their cancer getting worse (progression-free survival) for up to 5 years. You may be eligible if you are a man aged 18 or older with 1-5 asymptomatic lesions outside the prostate, identified by a PSMA PET/CT scan, and meet other health criteria. The study plans to enroll 107 participants, but its current status is unclear.

Study design
This interventional study plans to enroll 107 men. It compares two different radioactive drugs given with stereotactic body radiotherapy.
What's involved
Participants will receive intravenous (IV) infusions of either Actinium Ac 225 Vipivotide Tetraxetan or Lutetium Lu 177 Vipivotide Tetraxetan. They will also undergo blood sample collection and PSMA PET/CT scans.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 5 years to measure how long they live without their disease progressing or death.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07150715

Alpha-Emitting Radionuclide or Beta-Emitting Radionuclide With Metastasis-Directed Stereotactic Body Radiotherapy for the Treatment of Recurrent, Oligometastatic Prostate Adenocarcinoma

Recruiting
PHASE2Ages 18+InterventionalTreatment
Jonsson Comprehensive Cancer Center
~107 participants
Updated 2025-12-17 on ClinicalTrials.gov
What's tested:Actinium Ac 225 Vipivotide TetraxetanBiospecimen CollectionGallium Ga 68 GozetotideLutetium Lu 177 Vipivotide TetraxetanPSMA PET-CT ScanStereotactic Body Radiation Therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression free survival (PFS)
Measured over From the date of randomization to the date of disease progression or death, whichever happens earlier, up to 5 years

Conditions

Oligometastatic Prostate Adenocarcinoma
Recurrent Prostate Adenocarcinoma

Explore related trials

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Where it's being run

1 sites across 1 states
California1

Study leadership

  • Amar Kishan · PRINCIPAL_INVESTIGATOR · UCLA / Jonsson Comprehensive Cancer Center

Who to contact

Christy Palodichuk
[email protected]
3107942971
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Progression free survival (PFS)From the date of randomization to the date of disease progression or death, whichever happens earlier, up to 5 years

    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.