Clinical Trials /

Study of Abiraterone Acetate, Atezolizumab, Lupron, and Radiation Therapy in Men With Newly Diagnosed Hormone-sensitive Prostate Cancer

NCT04262154

Description:

This study is to find out whether adding the study drug atezolizumab and stereotactic body radiotherapy (SBRT) to standard treatment with abiraterone acetate, prednisone, and Lupron® (leuprolide) is a safe and effective way to treat previously untreated metastatic prostate cancer, and to see whether the study treatment works better than the standard treatment.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study of Abiraterone Acetate, Atezolizumab, Lupron, and Radiation Therapy in Men With Newly Diagnosed Hormone-sensitive Prostate Cancer
  • Official Title: SAABR: Single-Arm Phase II Study of Abiraterone Acetate + Atezolizumab + Lupron and Stereotactic Body Radiotherapy (SBRT) to the Prostate in Men With Newly Diagnosed Hormone-sensitive Metastatic Prostate Cancer

Clinical Trial IDs

  • ORG STUDY ID: 19-461
  • NCT ID: NCT04262154

Conditions

  • Metastatic Prostate Cancer

Interventions

DrugSynonymsArms
AtezolizumabMetastatic Prostate Cancer
AbirateroneMetastatic Prostate Cancer
PrednisoneMetastatic Prostate Cancer
LupronMetastatic Prostate Cancer

Purpose

This study is to find out whether adding the study drug atezolizumab and stereotactic body radiotherapy (SBRT) to standard treatment with abiraterone acetate, prednisone, and Lupron® (leuprolide) is a safe and effective way to treat previously untreated metastatic prostate cancer, and to see whether the study treatment works better than the standard treatment.

Trial Arms

NameTypeDescriptionInterventions
Metastatic Prostate CancerExperimentalParticipants will have untreated metastatic (M1a/b/c) hormone-sensitive prostate cancer documented by positive bone scan or metastatic lesion on CT or MRI; untreated is defined as having never received surgical, radiotherapeutic, or systemic therapy for their prostate cancer.
  • Atezolizumab
  • Abiraterone
  • Prednisone
  • Lupron

Eligibility Criteria

        Inclusion Criteria:

          -  Willing and able to provide or have a legally authorized representative to provide
             written informed consent and HIPAA authorization for the release of personal health
             information. A signed informed consent must be obtained before screening procedures
             are performed.

        NOTE: HIPAA authorization may be either included in the informed consent or obtained
        separately.

          -  Males 18 years of age and above

          -  Untreated metastatic (M1a/b/c) hormone-sensitive prostate cancer documented by
             positive bone scan or metastatic lesion on CT or MRI; untreated is defined as having
             never received surgical, radiotherapeutic, or systemic therapy for their prostate
             cancer.

          -  Biopsy-proven adenocarcinoma of the prostate

          -  Eligible for SBRT per institutional guidelines

          -  ECOG status of 0 or 1

          -  Normal organ function with acceptable initial laboratory values within 14 days of
             treatment start:

        ANC ≥ 1,500 /µl Albumin ≥ 3.5 g/dL Hemoglobin ≥ 9 g/dL Platelet count ≥ 100,000 /µl
        Creatinine > 30 mL/min (calculated using the Cockcroft-Gault Clearance formula) Potassium ≥
        3.5 mmol/L(within institutional normal range) Bilirubin < 1.5 x ULN (unless documented
        Gilbert's disease) SGOT(AST) < 1.5 x ULN SGPT(ALT) < 1.5 x ULN INR ≤ 1.5 x ULN

          -  Subjects must agree to use a medically acceptable method of birth control (e.g.,
             spermicide in conjunction with a barrier such as a condom) or sexual abstinence for
             the duration of the study, including 150 days after the last dose of study drug. Sperm
             donation is prohibited during the study and for 30 days after the last dose of study
             drug. Female partners must use hormonal or barrier contraception unless postmenopausal
             or abstinent.

        Exclusion Criteria:

          -  History of malignancy within 3 years prior to initiation of study treatment, except
             for malignancies with a negligible risk of metastasis of dead (e.g., 5-year OS rate
             >90%), such as non-melanoma skin carcinoma

          -  Pathological finding consistent with pure small cell carcinoma of the prostate

          -  Known or suspected brain metastasis or active leptomeningeal disease

          -  Asymptomatic lesions that would likely cause functional deficits or intractable pain
             with further growth (e.g. clinically significant epidural disease, structurally
             unstable bone lesions)

          -  Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent
             drainage procedures (one monthly or more frequently).

          -  Uncontrolled hypertension (systolic blood pressure ≥160 mmHg or diastolic BP ≥95
             mmHg). Subjects with a history of hypertension are allowed provided blood pressure is
             controlled by anti-hypertensive treatment

          -  Positive HIV test at screening

          -  Active hepatitis C virus (HCV) infection, defined as having a positive HCV antibody
             test followed by a positive HCV RNA test at screening. The HCV RNA test will be
             performed only for subjects who have a positive HCV antibody test.

          -  History of adrenal dysfunction

          -  Uncontrolled or symptomatic hypercalcemia (ionized calcium >1.5 mmol/L, calcium > 12
             mg/dL or corrected serum calcium > ULN)

          -  Active or history of autoimmune disease or immune deficiency, including, but not
             limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus
             erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid
             antibody syndrome, Wegener granulomatosis, Sjogren syndrome, Guillain-Barre syndrome,
             or multiple sclerosis, with the following exceptions:

               -  Subjects with a history of autoimmune-related hypothyroidism who are on thyroid
                  replacement hormone

               -  Subjects with controlled Type 1 diabetes mellitus who are on an insulin regimen

               -  Subjects with eczema, psoriasis, lichen simplex chronicus, or vitiligo with
                  dermatologic manifestations only (e.g., subjects with psoriatic arthritis are
                  excluded) are allowed provided all the following conditions are met:

          -  Rash must cover < 10% of body surface area

          -  Disease is well controlled at baseline and requires only low-potency topical
             corticosteroids

          -  No occurrence of acute exacerbations of the underlying condition requiring psoralen
             plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral
             calcineurin inhibitors, or high potency or oral corticosteroids within the previous 12
             months

          -  History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis
             obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of
             active pneumonitis on screening chest computed tomography (CT) scan

          -  Active tuberculosis

          -  Significant cardiovascular disease (such as New York Heart Association Class II or
             greater cardiac disease, myocardial infarction, cerebrovascular accident, unstable
             arrhythmia or unstable angina) within 6 months prior to initiation of study treatment

          -  Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation
             of study treatment, or anticipation of need for a major surgical procedure during the
             study

          -  Severe infection within 4 weeks prior to initiation of study treatment, including, but
             not limited to, hospitalization for complications of infection, bacteremia, or severe
             pneumonia

          -  Prior allogeneic stem cell or solid organ transplantation

               -  Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of
                  study treatment, or anticipation of need for such a vaccine during atezolizumab
                  treatment or within 5 months after the final dose of atezolizumab

          -  Treatment with investigational therapy within 28 days prior to initiation of study
             treatment

          -  Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including
             anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies

          -  Treatment with systemic immunostimulatory agents (including, but not limited to,
             interferon and interleukin 2 [IL-2]) within 4 weeks or 5 half-lives of the drug
             (whichever is longer) prior to initiation of study treatment

          -  Treatment with systemic immunosuppressive medication (including, but not limited to,
             corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and
             anti-TNF-a agents) within 2 weeks prior to initiation of study treatment, or
             anticipation of need for systemic immunosuppressive medication during study treatment,
             with the following exceptions:

               -  Subjects who received acute, low-dose systemic immunosuppressant medication or a
                  one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of
                  corticosteroids for a contrast allergy) are eligible for the study after Sponsor
                  Principal Investigator approval has been obtained.

               -  Subjects who received mineralocorticoids (e.g., fludrocortisone), corticosteroids
                  for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose
                  corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible
                  for the study

          -  History of severe allergic anaphylactic reactions to chimeric or humanized antibodies
             or fusion proteins

          -  Known hypersensitivity to Chinese hamster ovary cell products or to any component of
             the atezolizumab formulation

          -  Known allergy or hypersensitivity to any component of the abiraterone or prednisone
             formulations

          -  Any other disease, metabolic dysfunction, physical examination finding, clinical
             laboratory finding or situation that contraindicates the use of an investigational
             drug, may affect the interpretation of the results, or may render the subject at high
             risk from treatment complications
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

Measure:Failure-free rate at 2 years
Time Frame:2 years
Safety Issue:
Description:Failure is defined as: biochemical failure, radiographic progression defined by PCWG3, or death from any cause.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Memorial Sloan Kettering Cancer Center

Trial Keywords

  • Abiraterone Acetate
  • Atezolizumab
  • Lupron
  • Radiation Therapy
  • Hormone sensitive prostate cancer
  • Stereotactic Body Radiotherapy
  • SBRT
  • Metastatic prostate cancer
  • 19-461
  • Memorial Sloan Kettering Cancer Center

Last Updated

February 7, 2020