AAA817 for Prostate Cancer
(PSMAcTION Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called AAA817, a potential drug for prostate cancer that has spread and no longer responds to standard treatments. Researchers aim to assess the effectiveness of AAA817 compared to usual care. Eligible participants have prostate cancer detectable on PSMA PET/CT scans and have tried other unsuccessful treatments. The trial includes different groups to test varying doses of AAA817 and compare them to standard care. As a combined Phase 2 and Phase 3 trial, this study evaluates AAA817's effectiveness in a smaller group and represents the final step before FDA approval, offering early access to potentially effective treatment.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop your current medications. However, you cannot have taken any investigational agents within 28 days before joining the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that AAA817, a new treatment being tested for prostate cancer, is still under study to determine its safety and effectiveness. AAA817 targets specific parts of prostate cancer cells, delivering radiation directly to them. This method aims to attack cancer cells while avoiding damage to healthy ones.
There is not yet enough information to fully confirm the safety of AAA817. However, its testing in a Phase II/III study suggests that earlier research found it to be fairly well-tolerated. These phases typically follow initial studies that assess basic safety.
As with all new treatments under investigation, there is no guarantee that AAA817 will be free of side effects or risks. Participants in clinical trials may experience different reactions, so understanding the potential risks is crucial before deciding to join. Consulting healthcare providers is essential for making an informed choice.12345Why do researchers think this study treatment might be promising for prostate cancer?
Unlike the standard of care for prostate cancer, which often includes hormone therapy, radiation, or chemotherapy, AAA817 is a novel treatment option that researchers are excited about because it targets cancer cells in a unique way. While most treatments work by interfering with testosterone production or killing rapidly dividing cells, AAA817 offers a different mechanism, potentially leading to more precise targeting of cancer cells and fewer side effects. Its innovative approach provides hope for improved effectiveness in controlling prostate cancer, especially for patients who may not respond well to existing therapies.
What evidence suggests that this trial's treatments could be effective for prostate cancer?
Research shows that AAA817 attaches to a protein called PSMA, found on prostate cancer cells. This targeting helps reduce harm to other cells. Early results suggest that AAA817 could benefit patients whose cancer has worsened after other treatments. In this trial, participants will receive different doses of AAA817, including Dose A, Dose B, or the recommended Phase 3 dose, to evaluate its effectiveness and safety. Detailed success rates are not yet available, but this method is promising because it specifically targets cancer cells. The treatment is still under study to confirm its efficacy and safety.12567
Are You a Good Fit for This Trial?
This trial is for adults with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) who have already been treated with androgen receptor inhibitors, taxane-based chemotherapy, and progressed after [177Lu]Lu-PSMA therapy. They should be relatively active (ECOG status 0-2), have a confirmed diagnosis of adenocarcinoma of the prostate, testosterone levels under control (<50 ng/dL), and at least one metastatic lesion visible on recent scans.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase II Treatment
Participants receive AAA817 Dose A or Dose B for a number of cycles; each cycle is 8 weeks
Phase III Treatment
Participants receive the recommended Phase 3 dose of AAA817 or investigator's choice of Standard of Care; each cycle is 8 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- AAA817
Trial Overview
The study compares an investigational drug called AAA817 to the current standard treatments chosen by investigators for mCRPC that has worsened despite previous therapies. This Phase II/III trial aims to determine if AAA817 can provide better outcomes than existing treatment options.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Active Control
Rp3D of AAA817 will be given for a number of cycles; a cycle = 8 weeks
AAA817 will be given for a number of cycles; a cycle = 8 weeks
AAA817 Dose A will be given for a number of cycles: a cycle = 8 weeks
Participants will be given Standard of Care (SOC) treatment per Investigator's choice.
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
Citations
NCT06855277 | Study Comparing AAA817+ARPI Versus ...
AAA817 is being studied for treating PSMA positive mCRPC. Inside the body, it attaches itself to PSMA on the cell surface of the prostate cancer cells and emits ...
Open-label Study Comparing AAA817 Versus Standard of ...
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they ...
NCT06780670 | Open-label Study Comparing AAA817 ...
Study CAAA817A12201 consists of 2 parts: a randomized, open-label, international, multicenter, phase II study (Phase II) to collect more information to support ...
Study Comparing AAA817+ARPI Versus Standard of Care ...
AAA817 is being studied for treating PSMA positive mCRPC. Inside the body, it attaches itself to PSMA on the cell surface of the prostate cancer cells and emits ...
AAA817 for Prostate Cancer (PSMAcTION Trial)
This Phase II/III trial aims to determine if AAA817 can provide better outcomes than existing treatment options. How Is the Trial Designed? 4Treatment groups.
AAA 817 - AdisInsight - Springer
AAA 817 (also known as 225Ac-PSMA-617) is an alpha emitting radio-ligand therapy, that is being developed by Novartis through its subsidiary, Advanced.
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humanforschung-schweiz.ch
humanforschung-schweiz.ch/de/studiensuche/studien-detail/67077/translate/en/?cHash=323a76926be1feaefa39b6500d0d46ffA clinical study to learn more about the effects of AAA817 ...
AAA817 is a targeted cancer treatment that uses specific radiation to attack the PSMA molecule on prostate cancer cells. This study consists ...
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