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.
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
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
Parallel
Actinium Ac 225 Vipivotide Tetraxetan
DrugGiven IV
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Gallium Ga 68 Gozetotide
Other interventionGiven IV
Lutetium Lu 177 Vipivotide Tetraxetan
DrugGiven IV
PSMA PET-CT Scan
Procedure/SurgeryUndergo PSMA PET/CT scan
Stereotactic Body Radiation Therapy
RadiationUndergo SBRT
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.
Incidence of adverse events (AEs)
AEs will be summarized by type and grade.
Androgen deprivation therapy free survival
The KM method will be used to summarize.
Time to locoregional progression
The KM method will be used to summarize.
Time to new metastasis
The KM method will be used to summarize.
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Jonsson Comprehensive Cancer Center
Lead sponsor
Novartis Pharmaceuticals
Collaborator
