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

RecruitingPhase 2Ages 18 Years - anyMaleJonsson Comprehensive Cancer Center
NCT07150715 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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
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What it tests

  • Actinium Ac 225 Vipivotide Tetraxetan
  • Biospecimen Collection
  • Gallium Ga 68 Gozetotide
  • Lutetium Lu 177 Vipivotide Tetraxetan
  • PSMA PET-CT Scan
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Where

1 site
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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