Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan with ARPI vs. Without in First-line PSMA Positive Metastatic Castration-Resistant Prostate Cancer
Sponsor: Novartis Pharmaceuticals
ClinicalTrials ID:NCT06894511
This clinical trial is exploring whether combining a new treatment, AAA617, with ARPI can improve outcomes for patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) compared to using AAA617 alone.
Patient Parameters
| Parameter | Options |
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Program Overview
The study aims to find out if using AAA617 together with ARPI can help patients with PSMA-positive mCRPC live longer without their cancer getting worse, compared to using AAA617 by itself. This study is for patients who have already been treated with ARPI but whose cancer has progressed, and who have not received certain chemotherapy treatments before.
Description
This study involves adult patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) who have previously been treated with ARPI and have seen their cancer progress. Participants will be randomly assigned to one of two groups: one group will receive AAA617 combined with ARPI, and the other group will receive AAA617 alone. The study will take place in the United States and will involve about 420 participants. The main goal is to see if the combination treatment can help patients live longer without their cancer getting worse. Both groups will receive the best supportive care available, and androgen deprivation therapy (ADT) is required for all participants. The study will last approximately 3.5 years.
Eligibility Criteria
Inclusion Criteria
- Must be able to perform daily activities with minimal assistance (ECOG score 0-2).
- Must have a confirmed diagnosis of prostate cancer.
- Must have PSMA-positive cancer as shown by specific imaging tests.
- Must have low testosterone levels due to previous treatments.
- Must have cancer that has progressed after previous ARPI treatment.
- Must have at least one measurable cancer lesion on scans.
- Must have adequate blood and organ function as shown by specific lab tests.
Exclusion Criteria
- Cannot have received certain radiation treatments or PSMA-targeted therapies recently.
- Cannot have had taxane-based chemotherapy for mCRPC.
- Cannot have unstable brain metastases or be on steroids for brain issues.
- Cannot have spinal cord compression or signs of it.
- Cannot have certain genetic mutations that make other treatments more suitable.
- Cannot have had recent serious heart issues.
- Cannot have severe kidney problems.
- Other specific criteria may apply.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Cancer And Blood Spclsts of AZ | 85122 | Casa Grande | Arizona |
| Arizona Center for Cancer Care | 85297 | Gilbert | Arizona |
| Highlands Oncology Group | 72703 | Fayetteville | Arkansas |
| Hoag Memorial Hospital Presbyterian | 92663 | Newport Beach | California |
| Univ Of Color Anschutz Med Center | 80045 | Aurora | Colorado |
| Cancer Specialists of North Florida | 32256 | Jacksonville | Florida |
| East Jefferson Hospital | 70006 | Metairie | Louisiana |
| Urology Cancer Center PC | 68130 | Omaha | Nebraska |
| Northwest Cancer Specialists | 97210 | Portland | Oregon |
| Oregon Urology Institute | 97477 | Springfield | Oregon |
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