Study of Lutetium (177Lu) Vipivotide Tetraxetan for Metastatic Prostate Cancer
This study is looking at the safety, how well it's tolerated, and how radiation is distributed in the body when using Lutetium (177Lu) Vipivotide Tetraxetan (also called AAA617). This treatment is for men with metastatic castration-resistant prostate cancer (prostate cancer that has spread and is no longer responding to hormone therapy) who have not had chemotherapy before. You would receive AAA617 as an intravenous infusion (into a vein) every 6 weeks for up to 12 cycles. The study will also look at any side effects and how often doses need to be adjusted. To join, you must have prostate cancer that shows a specific biomarker called PSMA on a PET scan. The study aims to enroll about 106 participants, but its current status is unclear.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll about 106 adult men.
- What's involved
- You would undergo screening, receive AAA617 infusions every 6 weeks for up to 12 cycles, and have follow-up visits for safety and other assessments.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be followed for safety for up to 42 (+7) days after your last AAA617 dose, and for survival and progression after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study of Radiation Dosimetry, Safety, and Tolerability of Extended Lutetium (177Lu) Vipivotide Tetraxetan Treatment in Chemo-naïve Adults With Metastatic Castration-resistant Prostate Cancer: RADIOpharmaceutical DOSimetry Evaluation (RADIODOSE) Study
At a glance
Conditions
Where it's being run
21 sites across 14 statesStudy leadership
- Novartis Pharmaceuticals · STUDY_DIRECTOR · Novartis Pharmaceuticals
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Time activity curves (TACs) and absorbed radiation dose of AAA617 in organsFrom Cycle 1 to Cycle 12; cycle = 42 days
Time activity curve (TAC) will be generated from the amount radioactivity in one given tissue. Time integrated activity coefficient and absorbed dose will be calculated
- Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)For up to 12 cycles in taxane-naive participants with progressive PSMA-positive mCRPC with nrmal kidney function or mild renal impairment; cycle = 42 days
The distribution of adverse events for Radioligand Therapy (RLT) will be done via the analysis of frequencies for Adverse Event (AEs) and Serious Adverse Event (SAEs) through the monitoring of relevant clinical and laboratory safety parameters. Adverse event monitoring should be continued for at least 42 days following the end of treatment (EOT) visit. Participants receiving the study treatment will continue to be followed for safety every 12 weeks during the long-term follow-up for selected adverse events
- Percentage of participants with AAA617 dose reductions, interruptions and discontinuationsUp to 42 (+7) days after last AAA617 dose administration (Safety Follow-up)
The assessment of tolerability will be based on the frequency of participants with dose interruptions, reductions, and study treatment discontinuations. Dose reduction will be based on the worst toxicity demonstrated at the last dose.