Alpha- versus beta-emitting PSMA therapy plus targeted body radiation for recurrent oligometastatic prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase II trial compares two PSMA-targeted radioligand strategies given with stereotactic body radiotherapy (SBRT) for men with recurrent prostate cancer limited to 1–5 sites. One arm receives two cycles of Lutetium-177-PSMA-617 plus SBRT and the other receives one cycle of Actinium-225-PSMA-617 plus SBRT, with PSMA PET/CT imaging and biospecimen collection. The primary endpoint is progression-free survival defined by PSMA PET/CT at 24 months or earlier biochemical progression, initiation of salvage therapy, or death. Secondary endpoints include disease burden on PSMA PET/CT, physician-scored toxicity (CTCAE v5.0), patient-reported xerostomia, and ADT-free survival.

Why it matters

Who can join: the full rules

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

Where it's running

• UCLA / Jonsson Comprehensive Cancer Center
  Los Angeles, California, United States Recruiting

Study contacts

• Principal investigator: Amar Kishan — UCLA / Jonsson Comprehensive Cancer Center
• Study coordinator: Christy Palodichuk
• Email: cpalodichuk@mednet.ucla.edu
• Phone: 3107942971

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.