Study on Abiraterone Acetate or Enzalutamide, Atezolizumab, Hormone Therapy, and Radiation for Men with Newly Diagnosed Hormone-Sensitive Prostate Cancer

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60

ClinicalTrials ID:NCT04262154

This clinical trial is exploring whether adding the drug atezolizumab and targeted radiation therapy to standard treatments can safely and effectively treat men with newly diagnosed metastatic prostate cancer that responds to hormones.

Patient Parameters

Program Overview

The study aims to determine if combining the study drug atezolizumab and stereotactic body radiotherapy (SBRT) with standard treatments like abiraterone acetate, prednisone, and Lupron® (leuprolide) is a safe and effective way to treat men with metastatic prostate cancer that has not been treated before. Researchers want to see if this combination works better than the standard treatment alone.

Eligibility Criteria

Inclusion Criteria

  • Men aged 18 and older.
  • Have metastatic prostate cancer that is sensitive to hormones and has not been treated before.
  • Have a biopsy-confirmed diagnosis of prostate adenocarcinoma.
  • Eligible for targeted radiation therapy (SBRT) based on medical guidelines.
  • Have a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Normal organ function and acceptable lab results within 14 days before starting treatment.
  • Agree to use effective birth control methods during the study and for 150 days after the last dose of the study drug.
  • Willing to provide informed consent and authorization for the release of personal health information.

Exclusion Criteria

  • History of another cancer within the last 3 years, except for certain skin cancers.
  • Prostate cancer with a specific type of cell (small cell carcinoma).
  • Prostate volume greater than 80 cc.
  • Known or suspected brain metastasis or active disease in the brain or spinal fluid.
  • Uncontrolled pain related to the tumor.
  • Uncontrolled fluid buildup around the lungs, heart, or abdomen.
  • Uncontrolled high blood pressure.
  • Positive HIV test or active hepatitis B or C infection.
  • History of adrenal gland problems.
  • Uncontrolled high calcium levels in the blood.
  • Active or history of autoimmune diseases or immune deficiencies, with some exceptions.
  • History of certain lung diseases or active lung inflammation.
  • Active tuberculosis.
  • Significant heart disease within the last 6 months.
  • Major surgery within 4 weeks before starting the study.
  • Severe infection within 4 weeks before starting the study.
  • Previous organ or stem cell transplant.
  • Recent treatment with live vaccines, certain antibiotics, or investigational therapies.
  • Previous treatment with specific immune therapies or immune-stimulating drugs.
  • Use of systemic immunosuppressive medications recently or during the study, with some exceptions.
  • Severe allergic reactions to certain antibodies or components of the study drugs.
  • Any other condition that could interfere with the study or pose a risk to the participant.

Locations

FACILITYZIPCITYSTATE
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)07920Basking RidgeNew Jersey
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)07748MiddletownNew Jersey
Memorial Sloan Kettering Bergen (Limited Protocol Activities)07645MontvaleNew Jersey
Memorial Sloan Kettering Cancer Commack (Limited Protocol Activities)11725CommackNew York
Memorial Sloan Kettering Westchester (Limited Protocol Activities)10604HarrisonNew York
Columbia University10032New YorkNew York
Memorial Sloan Kettering Cancer Center10065New YorkNew York
Memorial Sloan Kettering Nassau (Limited Protocol Activities)11553UniondaleNew York

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