Study Comparing AAA817 with Standard Treatment for Advanced Prostate Cancer in Adults Who Have Previously Received PSMA Therapy
Sponsor: Novartis Pharmaceuticals
ClinicalTrials ID:NCT06780670
This clinical trial is testing a new treatment, AAA817, against the standard care for adults with advanced prostate cancer that has progressed after receiving PSMA-targeted therapy.
Patient Parameters
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Program Overview
This study is for adults with advanced prostate cancer that has spread and is resistant to standard hormone therapy. It aims to compare a new treatment, AAA817, with the usual care options. Participants must have previously received specific treatments, including PSMA-targeted therapy, and their cancer must have continued to grow despite these treatments.
Description
The study is divided into two parts. The first part (Phase II) will gather more information about the best dose of the new treatment, AAA817. The second part (Phase III) will compare the effectiveness and safety of AAA817 with the standard treatment options chosen by the doctor. This study is open to adults with advanced prostate cancer that has spread and is resistant to hormone therapy. Participants must have previously been treated with specific therapies, including PSMA-targeted therapy, and their cancer must have continued to grow despite these treatments. The study will take place at multiple international locations and will involve regular health checks and monitoring to assess the treatment's impact.
Eligibility Criteria
Inclusion Criteria
- Adults aged 18 or older.
- Able to perform daily activities with some limitations (ECOG score 0 to 2).
- Confirmed diagnosis of prostate cancer.
- Cancer must show PSMA positivity on a specific scan.
- Low testosterone levels due to previous treatments.
- Previously treated with hormone therapy and chemotherapy, and cancer has progressed after PSMA-targeted therapy.
- At least one tumor that can be measured on recent scans.
- Adequate kidney function as required by the study.
Exclusion Criteria
- Use of any experimental drugs within 28 days before starting the study.
- Previous treatment with certain investigational compounds.
- Unstable or symptomatic brain metastases or those requiring steroids.
- Recent or ongoing severe kidney problems.
- Moderate to severe dry mouth.
- Recent history of severe heart problems or uncontrolled high blood pressure.
- History of certain blood disorders or other cancers within the last 5 years, except for specific skin conditions or non-invasive colon polyps that have been treated.
- Other specific criteria may apply.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Indiana University | 46202 | Indianapolis | Indiana |
| Dana Farber Cancer Institute | 02115 | Boston | Massachusetts |
| WA Uni School Of Med | 63110 | St Louis | Missouri |
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