Study on Cabozantinib and Atezolizumab Compared to Second Hormonal Therapy in Men with Advanced Prostate Cancer

Sponsor: Exelixis

Sponsor score: 40

ClinicalTrials ID:NCT04446117

This clinical trial is testing a combination of two drugs, cabozantinib and atezolizumab, against a second hormonal therapy in men with advanced prostate cancer that has spread and is resistant to standard hormone treatments.

Patient Parameters

Program Overview

The study aims to find out if the combination of cabozantinib and atezolizumab is more effective than a second hormonal therapy in treating men with metastatic castration-resistant prostate cancer (mCRPC). Participants must have previously been treated with one hormonal therapy for their prostate cancer. The main goals are to compare how long patients live without the cancer getting worse and their overall survival. The study will also look at how many patients' tumors shrink with the treatment.

Description

This study is designed to compare the effectiveness of a new drug combination, cabozantinib and atezolizumab, with a second hormonal therapy (like abiraterone or enzalutamide) in men with advanced prostate cancer that has spread and is resistant to standard hormone treatments. The main focus is to see if this new combination can help patients live longer without their cancer progressing and improve overall survival rates. Researchers will also assess how many patients experience tumor shrinkage with the treatment. Participants must have previously received one hormonal therapy for their prostate cancer and have measurable disease outside the pelvis. The study will monitor patients' health and response to the treatment through various tests and assessments.

Eligibility Criteria

Inclusion Criteria

  • Men diagnosed with prostate cancer that has spread and is resistant to standard hormone treatments.
  • Previously treated with one hormonal therapy for prostate cancer.
  • Undergoing surgical or medical castration with low testosterone levels.
  • Have measurable cancer outside the pelvis, such as in organs like the liver or lungs.
  • Cancer must be progressing at the time of study entry.
  • Aged 18 or older.
  • In good overall health with an ECOG performance status of 0 or 1.
  • Have recovered from any side effects of previous treatments.
  • Have adequate organ and bone marrow function based on lab tests.
  • Able to understand and follow study requirements.

Exclusion Criteria

  • Have received any non-hormonal therapy for advanced prostate cancer.
  • Recently taken certain hormonal therapies or radiation treatments.
  • Have untreated or unstable brain metastases.
  • Have spinal cord compression or related symptoms.
  • Taking certain blood thinners or have received a live vaccine recently.
  • Require high doses of steroids or other immune-suppressing medications.
  • Have uncontrolled or serious health conditions.
  • Have had major surgery recently.
  • Have heart rhythm issues or cannot swallow pills.
  • Allergic to study drugs or have had severe reactions to similar treatments.
  • Have another active cancer or a recent history of another cancer requiring treatment.

Locations

FACILITYZIPCITYSTATE
Exelixis Clinical Site #485741TucsonArizona
Exelixis Clinical Site #4291010DuarteCalifornia
Exelixis Clinical Site #292835FullertonCalifornia
Exelixis Clinical Site #22492093-0698La JollaCalifornia
Exelixis Clinical Site #390292Marina del ReyCalifornia
Exelixis Clinical Site #11492161San DiegoCalifornia
Exelixis Clinical Site #12590404Santa MonicaCalifornia
Exelixis Clinical Site #24594305StanfordCalifornia
Exelixis Clinical Site #9180045AuroraColorado
Exelixis Clinical Site #1480211DenverColorado

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