Lutetium-177 for Prostate Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests an experimental treatment called Lutetium-177 Vipivotide Tetraxetan for prostate cancer that has spread and resists traditional hormone treatments. Researchers aim to understand how this treatment behaves in the body, particularly in individuals with kidney issues, and whether it affects heart rhythm. Suitable candidates include those with worsening prostate cancer despite treatment and stable kidney disease. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
The trial requires that you stop using any medications known to prolong the QT interval (a measure of heart rhythm) from the start of screening to the end of the first treatment cycle, unless you can stop them permanently for the study duration.
Is there any evidence suggesting that lutetium (177Lu) vipivotide tetraxetan is likely to be safe for humans?
Research shows that lutetium (177Lu) vipivotide tetraxetan may help treat prostate cancer. Patients in earlier studies experienced improvements in their prostate-specific antigen (PSA) levels, which doctors use to monitor prostate cancer. In one study, 68.9% of participants had their PSA levels drop by at least 10%, and 55.6% saw a reduction of 50% or more. While these results are promising, awareness of possible side effects is important.
Earlier studies suggest that the treatment is generally well-tolerated. However, like any treatment, it can have side effects. The most common ones include fatigue, nausea, and dry mouth. Serious side effects are less common but can occur. Notably, the FDA has approved this treatment for another condition, indicating some confidence in its safety.
In summary, lutetium (177Lu) vipivotide tetraxetan has shown potential benefits in treating prostate cancer, and while side effects are possible, the treatment is usually well-tolerated.12345Why do researchers think this study treatment might be promising for prostate cancer?
Lutetium (177Lu) Vipivotide Tetraxetan is unique because it combines a radioactive isotope, Lutetium-177, with a targeting molecule that seeks out prostate-specific membrane antigen (PSMA) on cancer cells. Unlike standard treatments like hormone therapy or chemotherapy, which can affect both healthy and cancerous cells, this treatment delivers targeted radiation directly to the prostate cancer cells, potentially minimizing damage to healthy tissue. Researchers are excited because this targeted approach could lead to fewer side effects and improved outcomes for patients with advanced prostate cancer.
What evidence suggests that Lutetium-177 might be an effective treatment for prostate cancer?
Research shows that lutetium-177 vipivotide tetraxetan, also known as Pluvicto™, can help treat prostate cancer. In this trial, participants will receive the treatment under the label AAA617. Studies have found that this treatment, when combined with standard care, reduces the risk of cancer progression or death by 28%. Additionally, 68.9% of patients experienced at least a 10% decrease in a key cancer marker (PSA), and more than half saw a reduction of 50% or more. On average, patients starting this therapy live about 15.3 months. These findings suggest that lutetium-177 vipivotide tetraxetan could be a promising option for prostate cancer patients.23467
Who Is on the Research Team?
Novartis Pharmaceuticals
Principal Investigator
Novartis Pharmaceuticals
Are You a Good Fit for This Trial?
This trial is for adults with advanced prostate cancer that's spread and doesn't respond to hormone therapy. They need different levels of kidney function, from normal to severely impaired, but stable. Participants must show cancer progression through bone scans or rising PSA levels, have a decent performance status (able to carry out daily activities), and testosterone under control.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a dose of 7.4 GBq (±10%) of AAA617 once every 6 weeks for 3 to 6 cycles based on renal function
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long Term Follow-up
Participants are monitored for safety up to 10 years after the first dose of AAA617
What Are the Treatments Tested in This Trial?
Interventions
- Lutetium (177Lu) Vipivotide Tetraxetan
Trial Overview
The study tests Lutetium (177Lu) Vipivotide Tetraxetan in patients with varying degrees of kidney health. It aims to see how the drug spreads in the body, its safety profile, and if it affects heart rhythm in those with metastatic castration-resistant prostate cancer.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants will receive a dose of 7.4 GBq (200 mCi) ± 10% of AAA617 which will be administered once every 6 weeks (1 cycle) for up to 6 cycles if enrolled in Cohorts A or B. Participants with severe renal impairment (in cohort C) will receive a dose of 7.4 GBq of AAA617 for up to 3 cycles of treatment. Based on the emerging safety data and if the investigators deem the participant is still benefiting from study drug, 3 additional cycles may be administered for Cohort C participants.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novartis Pharmaceuticals
Lead Sponsor
Dr. Vas Narasimhan
Novartis Pharmaceuticals
Chief Executive Officer since 2018
MD from Harvard Medical School
Dr. Shreeram Aradhye
Novartis Pharmaceuticals
Chief Medical Officer since 2021
MD
Published Research Related to This Trial
Citations
Patient characteristics and overall survival with lutetium ...
The median overall survival from the start of ¹⁷⁷Lu-PSMA-617 therapy was 15.3 months (95% CI: 14.6–16.3), with 137 of 643 patients (21.3%) ...
Clinical outcomes of lutetium-177-vipivotide tetraxetan in ...
In this retrospective study of 177 Lu, we see similar PSA and PSA50 responses to reported trials. However, PFS was shorter, and mortality was higher.
3.
novartis.com
novartis.com/news/media-releases/psmaddition-data-show-novartis-pluvictotm-delays-progression-end-stage-prostate-cancerPSMAddition data show Novartis Pluvicto™ delays ...
PluvictoTM plus standard of care (ARPI + ADT) significantly reduced risk of progression or death by 28% (HR 0.72) versus SoC alone, ...
Lutetium Lu 177 Vipivotide Tetraxetan Efficacy and Toxicity ...
68.9% of the cohort observed PSA biomarker improvement of ≥10%, and 55.6% with ≥50% PSA reduction. Three patients (6.7%) achieved a complete ...
NCT05939414 | An Open-label Study Comparing Lutetium ...
The purpose of this study is to evaluate the efficacy and safety of lutetium (177Lu) vipivotide tetraxetan (AAA617) in participants with oligometastatic ...
Lutetium Lu 177 Vipivotide Tetraxetan for Patients with ...
The FDA granted approval based on a statistically significant and clinically meaningful improvement in overall survival when 177Lu-PSMA-617 was combined with ...
Real world outcomes in patients with metastatic castration ...
47 patients (71%) had an overall decline in their PSA from baseline, with 32 patients (49%) experiencing a decrease greater than fifty percent.
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