For men facing oligometastatic prostate cancer, a new treatment called lutetium vipivotide tetraxetan is being tested to see if it can help. This study aims to find out if this drug can effectively delay the progression of cancer after initial treatment. Participants will undergo thorough assessments, including scans to evaluate their cancer. Those in the study will receive either the new drug or standard observation. All participants will also receive targeted radiation therapy to treat their cancer spots. The goal is to see if the new treatment can extend the time before the cancer spreads, which is crucial for maintaining a better quality of life. With 450 participants expected, the results could provide valuable insights into managing early-stage prostate cancer and potentially reduce the need for more intense treatments like hormone therapy.
Phase 3 Study of Lutetium (177Lu) Vipivotide Tetraxetan in OMPC PatientsCan a new treatment delay prostate cancer from spreading further?
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Key Takeaway
Evaluate lutetium (177Lu) vipivotide tetraxetan for MFS in oligometastatic prostate cancer.
This Phase 3 study is currently recruiting participants to evaluate the efficacy and safety of lutetium (177Lu) vipivotide tetraxetan (AAA617) in patients with oligometastatic prostate cancer (OMPC) who have progressed after definitive therapy to their primary tumor. The trial aims to determine if AAA617 can control tumor recurrence and delay progression to fatal metastatic disease while maintaining quality of life by postponing androgen deprivation therapy (ADT). Participants will undergo baseline disease assessments, including mandatory PET/CT scans using gallium (68Ga) gozetotide or piflufolastat (18F), depending on the country. Stereotactic Body Radiation Therapy (SBRT) will be administered to all metastatic lesions post-randomization and prior to starting AAA617 or observation. The primary outcome is Metastasis Free Survival (MFS) as assessed by a Blinded Independent Review Committee (BIRC). The study, sponsored by Novartis Pharmaceuticals, plans to enroll 450 participants, with an estimated primary completion date of April 25, 2028.
What this means for you:
A new drug may help delay prostate cancer progression and improve patients' quality of life. 
View Original Abstract ↓
Status: RECRUITING | Phase: PHASE3
Condition(s): Oligometastatic Prostate Cancer (OMPC)
Intervention(s): AAA617 (DRUG)
The purpose of this study is to evaluate the efficacy and safety of lutetium (177Lu) vipivotide tetraxetan (AAA617) in participants with oligometastatic prostate cancer (OMPC) progressing after definitive therapy to their primary tumor. The data generated from this study will provide evidence for the treatment of AAA617 in early-stage prostate cancer patients to control recurrent tumor from progressing to fatal metastatic disease while preserving quality of life by delaying treatment with androgen deprivation therapy (ADT).
Detailed: All participants will be assessed for eligibility and will undergo baseline disease assessments including a mandatory gallium (68Ga) gozetotide (also known as \[68Ga\]Ga-PSMA-11) or piflufolastat (18F) ( also known as\[18F\]DCFPyL) PET/CT scan and CI (i.e., CT/MRI and bone scans).
Piflufolastat (18F) PET/CT scan will be performed in countries where it is approved.
Stereotactic Body Radiation Therapy (SBRT) will be administered to all metastatic Prostate Cancer (PC) lesions after randomization and before the start of treatment with AAA617 or observation.
* The duration of SBRT procedures is approximately 3 weeks.
* For participants randomized to the investigational arm (AAA617), the treatment duration will be up to 4 cycles of AAA617. For participants randomized to the control arm (obser
Primary Outcome(s): Blinded Independent Review Committee (BIRC) assessed Metastasis Free Survival (MFS)
Enrollment: 450 (ESTIMATED)
Lead Sponsor: Novartis Pharmaceuticals
Start: 2024-03-12 | Primary Completion: 2028-04-25
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