Lutetium Vipivotide Tetraxetan for Prostate Cancer
(RADIODOSE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety and tolerability of a new treatment, Lutetium Vipivotide Tetraxetan (a radioligand therapy), for prostate cancer that has spread and resists hormone treatments. The trial targets individuals who have not received certain chemotherapy drugs and have normal or mild kidney function. Ideal participants are adults with metastatic prostate cancer, confirmed by special imaging, who have previously tried hormone therapy without success. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications. However, you cannot take certain treatments like chemotherapy, immunotherapy, or radioligand therapy while participating in the study.
Is there any evidence suggesting that Lutetium (177Lu) Vipivotide Tetraxetan is likely to be safe for humans?
Research has shown that Lutetium (177Lu) Vipivotide Tetraxetan, also known as Pluvicto, has been tested in people with prostate cancer. This treatment uses a radioactive drug to specifically target cancer cells. Past studies have used it in patients with similar conditions, and the FDA has approved it for certain prostate cancer treatments.
Reports indicate that while patients generally tolerate the treatment well, some may experience side effects such as tiredness, dry mouth, and nausea. Since it involves radiation, there is a potential risk of developing other cancers. However, these risks are weighed against the benefits of treating prostate cancer.
Overall, Lutetium (177Lu) Vipivotide Tetraxetan has shown promise in previous studies with prostate cancer patients. Discussing any potential risks with a healthcare provider is important.12345Why do researchers think this study treatment might be promising for prostate cancer?
Unlike the standard treatments for prostate cancer, which typically involve hormone therapy, chemotherapy, or surgery, Lutetium Vipivotide Tetraxetan offers a novel approach by using targeted radiation. This treatment is unique because it involves Lutetium-177, a radioactive isotope that delivers radiation directly to prostate cancer cells, minimizing damage to surrounding healthy tissues. Researchers are excited about this because it promises more precise targeting of cancer cells, potentially leading to fewer side effects and improved effectiveness compared to current treatments.
What evidence suggests that Lutetium (177Lu) Vipivotide Tetraxetan might be an effective treatment for prostate cancer?
Research has shown that a treatment called Lutetium (177Lu) Vipivotide Tetraxetan, or AAA617, may help treat prostate cancer. In this trial, all participants will receive the investigational product AAA617. One study found that patients using this treatment lived for an average of about 15.3 months. Additionally, 68.9% of patients experienced at least a 10% improvement in their PSA levels, a protein indicating prostate cancer activity, and 55.6% saw a reduction of 50% or more. Some patients even experienced complete remission. These findings suggest that AAA617 could effectively manage advanced prostate cancer.678910
Who Is on the Research Team?
Novartis Pharmaceuticals
Principal Investigator
Novartis Pharmaceuticals
Are You a Good Fit for This Trial?
Adults over 18 with metastatic castration-resistant prostate cancer (mCRPC) that's PSMA-positive. They should have normal or mildly impaired kidney function, an ECOG performance status ≤1, and testosterone levels under control by treatment or surgery. Only those who've progressed after one type of advanced hormone therapy can join.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive up to 12 cycles of AAA617 treatment every 6 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term Follow-up
Participants are followed for safety every 12 weeks for selected adverse events
What Are the Treatments Tested in This Trial?
Interventions
- Lutetium (177Lu) Vipivotide Tetraxetan
Lutetium (177Lu) Vipivotide Tetraxetan is already approved in United States, European Union for the following indications:
- Prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer
- Prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer
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