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Actinium Ac 225 Vipivotide Tetraxetan

Phase 2

Oligometastatic Prostate Adenocarcinoma | Small molecule | Oncology |Novartis AG|Last Updated: Sep 17, 2026

Success Probability

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Trial Design

RandomizedCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment107

FDA Designations

No designations recorded

Clinical trial landscape

Actinium Ac 225 Vipivotide Tetraxetan · 1 trial · 2 indications

Phase 2 1
NCT07150715Alpha-Emitting Radionuclide or Beta-Emitting Radionuclide With Metastasis-Directed Stereotactic Body Radiotherapy for the Treatment of Recurrent, Oligometastatic Prostate AdenocarcinomaOligometastatic Prostate Adenocarcinoma
RECRUITING107 Analytics
PHASE2RECRUITING
Alpha-Emitting Radionuclide or Beta-Emitting Radionuclide With Metastasis-Directed Stereotactic Body Radiotherapy for the Treatment of Recurrent, Oligometastatic Prostate Adenocarcinoma
Oligometastatic Prostate Adenocarcinoma
NCT07150715107
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Study Endpoints

Primary Endpoints

Progression free survival (PFS)
From the date of randomization to the date of disease progression or death, whichever happens earlier, up to 5 years

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.

Secondary Endpoints

Incidence of adverse events (AEs)
From time of randomization, up to 5 years
Androgen deprivation therapy free survival
Up to 5 years
Time to locoregional progression
Up to 5 years
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm I (177Lu-PSMA-617)EXPERIMENTALPatients 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)EXPERIMENTALPatients 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.

Interventions

NameTypeDescription
Actinium Ac 225 Vipivotide TetraxetanDRUGGiven IV
Biospecimen CollectionPROCEDUREUndergo blood sample collection
Gallium Ga 68 GozetotideOTHERGiven IV
Lutetium Lu 177 Vipivotide TetraxetanDRUGGiven IV
PSMA PET-CT ScanPROCEDUREUndergo PSMA PET/CT scan
Stereotactic Body Radiation TherapyRADIATIONUndergo SBRT
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Eligibility Criteria

Age Range18 Years to N/A
SexMALE
Healthy VolunteersNo
Study Sites1

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...

Countries:United States
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