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.
Can a new treatment delay prostate cancer from spreading further?
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What this means for you:
A new drug may help delay prostate cancer progression and improve patients' quality of life. 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