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Also known as 225Ac-labeled PSMA-617, 225Ac-PSMA-617, 225Ac-Vipivotide Tetraxetan, Actinium (225AC) PSMA-617, Actinium Ac 225 PSMA-617, VIPIVOTIDE TETRAXETAN ACTINIUM AC-225
Actinium Ac 225 Vipivotide Tetraxetan · 1 trial · 2 indications
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.
| Arm | Type | Description |
|---|---|---|
| Arm I (177Lu-PSMA-617) | EXPERIMENTAL | Patients receive 177Lu-PSMA-617 IV, over 1-10 minutes, on day one of each cycle. Cycles repeat every 6 weeks for 2 cycles. 4-6 weeks after completion of 177Lu-PSMA-617 patients receive 68Ga-PSMA-11 IV and undergo PSMA PET/CT scan. Within 4 weeks of the scan, patients receive SBRT, for 1-5 treatments, over 1- 1- days. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo PSMA PET/CT scan and blood sample collection throughout the study. |
| Arm II (225Ac-PSMA-617) | EXPERIMENTAL | Patients receive 225Ac-PSMA-617 IV once. 4-6 weeks after completion of 225Ac-PSMA-617 patients receive 68Ga-PSMA-11 IV and undergo PSMA PET/CT scan. Within 4 weeks of the scan, patients receive SBRT, for 1-5 treatments, over 1- 1- days. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo PSMA PET/CT scan and blood sample collection throughout the study. |
| Name | Type | Description |
|---|---|---|
| Actinium Ac 225 Vipivotide Tetraxetan | DRUG | Given IV |
| Biospecimen Collection | PROCEDURE | Undergo blood sample collection |
| Gallium Ga 68 Gozetotide | OTHER | Given IV |
| Lutetium Lu 177 Vipivotide Tetraxetan | DRUG | Given IV |
| PSMA PET-CT Scan | PROCEDURE | Undergo PSMA PET/CT scan |
| Stereotactic Body Radiation Therapy | RADIATION | Undergo SBRT |
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 s...
Actinium Ac 225 Vipivotide Tetraxetan is being studied for the treatment of recurrent, oligometastatic prostate adenocarcinoma. It is an investigational therapy in Phase 2 development and is not approved for any indication. The research focuses on patients with a limited number of metastatic lesions, a setting known as oligometastatic disease.
Actinium Ac 225 Vipivotide Tetraxetan is being developed by Novartis AG, which trades under the ticker NVS. Novartis is the sponsor of the clinical program evaluating this therapy in prostate cancer.
Actinium Ac 225 Vipivotide Tetraxetan is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The ongoing Phase 2 trial is currently recruiting participants.
Actinium Ac 225 Vipivotide Tetraxetan is being evaluated in a single Phase 2 clinical trial, NCT07150715. The trial is titled Alpha-Emitting Radionuclide or Beta-Emitting Radionuclide With Metastasis-Directed Stereotactic Body Radiotherapy for the Treatment of Recurrent, Oligometastatic Prostate Adenocarcinoma. It is recruiting in the United States and plans to enroll 107 male participants aged 18 years and older.
Actinium Ac 225 Vipivotide Tetraxetan is a small molecule therapy that combines the alpha-emitting radionuclide actinium-225 with a targeting vector. The trial compares an alpha-emitting radionuclide with a beta-emitting radionuclide, both given alongside metastasis-directed stereotactic body radiotherapy, in recurrent, oligometastatic prostate adenocarcinoma.