Alpha- versus beta-emitting PSMA therapy plus targeted body radiation for recurrent oligometastatic prostate cancer
Alpha-Emitting Radionuclide or Beta-Emitting Radionuclide Combined With Metastasis-Directed Stereotactic Body Radiotherapy for Oligorecurrent Prostate Adenocarcinoma (ANDROMEDA)
This tests whether adding either an alpha-emitting PSMA drug (225Ac-PSMA-617) or a beta-emitting PSMA drug (177Lu-PSMA-617) to precise stereotactic body radiotherapy helps control recurrent oligometastatic prostate cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 107 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Jonsson Comprehensive Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT07150715 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Men with histologically confirmed prostate adenocarcinoma who have 1–5 asymptomatic PSMA-PET–positive extracapsular lesions, testosterone >150 ng/dL, ECOG ≤2, and adequate blood counts, liver and renal function are ideal candidates.
Not a fit: Patients with more than five metastatic sites, symptomatic or rapidly progressing disease requiring urgent therapy, low PSMA expression on imaging, or inadequate organ function or blood counts are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, this approach could lengthen the time before cancer progresses and delay the need for systemic hormonal therapy in men with limited recurrent disease.
How similar studies have performed: Beta-emitting 177Lu-PSMA therapies have shown benefit in advanced metastatic castration‑resistant prostate cancer in prior trials, while Actinium-225 PSMA therapies are promising but less extensively studied, and combining either agent with SBRT in oligorecurrent disease is a relatively new strategy.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Los Angeles, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.