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Lutetium (177Lu) Vipivotide Tetraxetan for Oligometastatic Prostate Cancer

This study is testing a treatment called lutetium (177Lu) vipivotide tetraxetan (AAA617) for men with oligometastatic prostate cancer (OMPC), which means their cancer has spread to a few spots. The goal is to see if AAA617, given after Stereotactic Body Radiation Therapy (SBRT), can help control the cancer and delay the need for other treatments, while maintaining your quality of life. You may be eligible if you are a man aged 18 to 100 with prostate cancer that has come back after initial treatment. The study will measure how long you live without new cancer spread (Metastasis Free Survival). The current recruitment status is unclear, and the study aims to enroll 450 participants.

Study design
This is an open-label study, meaning you and your doctors will know which treatment you are receiving. It compares AAA617 plus SBRT to observation plus SBRT, and plans to enroll 450 participants.
What's involved
You will have a PET/CT scan and other imaging tests. If randomized to the investigational arm, you will receive AAA617 once every 6 weeks for up to 4 cycles, after SBRT. Visits will be weekly for the first three weeks of each cycle, then every 16 weeks until your cancer progresses.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for up to approximately 30 months to assess for new cancer spread or death. The total study duration is approximately 6.5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05939414

An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC.

Recruiting
PHASE3Ages 18+InterventionalTreatment
Novartis Pharmaceuticals
~450 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:AAA617

At a glance

Recruiting sites
141 of 144 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Blinded Independent Review Committee (BIRC) assessed Metastasis Free Survival (MFS)
Measured over From date of randomization until first evidence of radiographically detectable bone or soft tissue distant metastasis or death due to any cause, whichever occurs first, assessed up to approximately 30 months

Conditions

Oligometastatic Prostate Cancer (OMPC)

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Where it's being run

144 sites across 81 states
Germany6
Japan6
France5
Israel5
Spain5
California4
Slovakia4
Taiwan4

Study leadership

  • Novartis Pharmaceuticals · STUDY_DIRECTOR · Novartis Pharmaceuticals

Who to contact

Novartis Pharmaceuticals
[email protected]
1-888-669-6682
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

For a participant not to be eligible, CI positive M1 lesions should be unequivocal in CI scans, i.e., potentially not attributable to findings thought to represent something other than tumor (e.g., degenerative, or post-traumatic changes or Paget's disease in bone lesions). For CI assessments, bone lesions must be assessed by bone scan only and soft tissue lesions must be assessed by CT/MRI scans only at screening.
Prior knowledge of PSMA PET positivity should not influence the radiologist (reader) in determination of CI positivity. Two different readers will be involved, one reader for PSMA PET/CT scan and one reader for CI: Reader will be blinded to PSMA PET scan results while reading CI scans. Reader should not modify their assessment of CI scans (e.g. changing a lesion previously identified as equivocal in CI to unequivocal) after reading the PSMA PET scan. Similarly, biopsy positivity should not influence the reader in the assessment of CI positivity. More details on the reading paradigm will be provided in the imaging charter
MRI for radiation treatment planning may show M1 disease but this will not exclude the participant from the study if the lesion is deemed negative per baseline CT or bone scans
Participants with pelvic disease (N1) seen in CI are allowed if the local spread is below common iliac bifurcation (per AJCC 8 definition of local disease)
Distant lymph node disease (M1a) that is visible per CI and less than 10mm in the short axis is not exclusionary irrespective of PSMA PET positivity.
If a previously surgically removed lesion was unequivocal for M1 by bone scan or CT, the participant is not eligible. 6. All metastatic lesions detected at screening must be amenable to SBRT 7. Non-castration testosterone level \>100 ng/dL at screening

Exclusion

Participants who received AR-directed therapy, whether ADT or an ARPI or both, as neoadjuvant or adjuvant therapy as a component of their primary therapy, are eligible provided that they discontinued therapy ≥12 months prior to randomization for ADT (i.e., 12 months after the last day of the last injection) or ≥3 months if ARPI was given as monotherapy. ARPI's as a term includes both contemporary androgen synthesis inhibitors (e.g., abiraterone, galeterone, and orteneronel), and receptor inhibitors (enzalutamide, apalutamide and darolutamide).
Patients who biochemically relapsed after primary therapy may also have had treatment with AR directed therapy and participants who had SBRT with ADT are also eligible provided that the ARPI +/- ADT or ADT alone was terminated
Participants who received first generation anti-androgens (bicalutamide, flutamide, nilutamide, cyproterone) for biochemical recurrence or adjuvant/neoadjuvant therapy are eligible provided that they discontinued therapy ≥3 months prior to randomization.
Participants who have discontinued ADT due to disease progression are not eligible (i.e., Castration-Resistant Prostate Cancer (CRPC) participants) 2. Other hormonal therapy. e.g.,
Concomitant clinically significant cardiac arrhythmias, e.g. sustained ventricular tachycardia, and clinically significant second or third degree Atrioventricular (AV) block without a pacemaker
History of familial long QT syndrome or known family history of Torsades de Pointe 8. Participants in immediate need of ADT as assessed by the investigator.

What this trial measures

  • Blinded Independent Review Committee (BIRC) assessed Metastasis Free Survival (MFS)From date of randomization until first evidence of radiographically detectable bone or soft tissue distant metastasis or death due to any cause, whichever occurs first, assessed up to approximately 30 months

    Blinded Independent Review Committee (BIRC) assessed Metastasis Free Survival (MFS) is defined as the time from randomization to first evidence of radiographically detectable bone or soft tissue distant metastasis by conventional imaging (i.e., Computed Tomography (CT)/Magnetic Resonance Imaging (MRI) and bone scans) as assessed by BIRC using RECIST 1.1 or death due to any cause, whichever occurs first. Participants who are alive without distant metastasis at the analysis data cut-off or are lost to follow-up at the time of analysis will be censored for MFS at the time of their last adequate radiographic assessment. Clinical deterioration without objective radiographic evidence will not be considered as documented distant metastasis.