Alpha-Emitting Radionuclide or Beta-Emitting Radionuclide Combined With Metastasis-Directed Stereotactic Body Radiotherapy for Oligorecurrent Prostate Adenocarcinoma (ANDROMEDA)
Jonsson Comprehensive Cancer Center
Summary
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.
Description
PRIMARY OBJECTIVE: I. To assess progression-free survival for men with oligorecurrent prostate cancer after stereotactic body radiotherapy (SBRT) in combination with 2 cycles of Lutetium Lu 177 Vipivotide Tetraxetan (177Lu-PSMA-617) versus SBRT in combination with 1 cycle of Actinium Ac 225 Vipivotide Tetraxetan (225Ac-PSMA-617), with progression defined on the basis of prostate specific membrane antigen (PSMA) positron emission tomography (PET)/computed tomography (CT) scans obtained at 24 months post-SBRT or at the time of prostate specific antigen (PSA)-based biochemical progression, initi…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
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…
Interventions
- DrugActinium Ac 225 Vipivotide Tetraxetan
Given IV
- ProcedureBiospecimen Collection
Undergo blood sample collection
- OtherGallium Ga 68 Gozetotide
Given IV
- DrugLutetium Lu 177 Vipivotide Tetraxetan
Given IV
- ProcedurePSMA PET-CT Scan
Undergo PSMA PET/CT scan
- RadiationStereotactic Body Radiation Therapy
Undergo SBRT
Location
- UCLA / Jonsson Comprehensive Cancer CenterLos Angeles, California