Study of Abiraterone Acetate or Enzalutamide, Atezolizumab, GnRH Analog and Radiation Therapy in Men With Newly Diagnosed Hormone-sensitive Prostate Cancer

Running, not enrolling · Phase 2

Conditions studied: Metastatic Prostate Cancer

In brief

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.

Key facts

Study ID

NCT04262154

Run by

Memorial Sloan Kettering Cancer Center

People needed

28

Starts

2020-03-03

Expected to finish

2026-09-01

Last updated by the study team

2026-05-11

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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 to the prostate for cancer for their prostate cancer.
• Note, 10 subjects who have had prior hormonal therapy (GnRH analog +/- first-generation anti-androgen such a bicalutamide) started up to 3 months prior to signing consent to the trial will be permitted to enroll onto the study if they have demonstrated a decline in PSA. Anti-androgens must be stopped prior to Cycle 1.
• Note: patients who have started bicalutamide (Casodex) with or without a GnRH analog must stop prior to being registered on trial
• 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 Lymphocyte count ≥ 0.5 x 109/L (500/µL) Albumin ≥ 3.5 g/dL Hemoglobin ≥ 9 g/dL Platelet count ≥ 100,000 /µl Creatinine within institutional normal limits Potassium ≥ 3.5 mmol/L(within institutional normal range) Bilirubin ≤1.5 x ULN Patients with known Gilbert disease: serum bilirubin ≤3 x ULN)
• SGOT(AST), SGPT ≥ 2.5 ULN with the following exceptions:
• (ALT), and AST and (ALT), and Alkaline Phosphatase (ALP) Patients with documented liver metastases: AST and ALT ≤ 5 x ULN; Patients with documented liver or bone metastases: ALP ≤ 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.

You may not qualify if…

• 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
• Prostate volume > 80 cc
• Known or suspected brain metastasis or active leptomeningeal disease
• Uncontrolled tumor-related pain. Patients requiring pain medication must be on a stable regimen at study entry. Symptomatic lesions (e.g. bone metastases causing nerve impingement) amenable to palliative radiotherapy should be treated prior to enrollment. Patient should be recovered from effects of radiation. There is no required minimum recovery period. Asymptomatic metastatic lesions that would likely cause functional deficits or intractable pain with further growth (e.g.,epidural metastasis that is not currently associated with spinal cord compression) should be considered for loco-regional therapy if appropriate prior to enrollment).
• 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 B virus (HBV) infection (chronic or acute), defined as having a positive hepatitis B surface antigen (HBsAg) test and/or HBV PCR at screening. Patients currently treated with anti-viral therapy for HBV. Subjects with a past or resolved HBV infection, defined as having a negative HBsAg and HBV PCR test and a positive total hepatitis B core antibody (HBcAb) test at screening, are eligible for the study.
• 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

Where it is running

• Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey, United States
• Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown, New Jersey, United States
• Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale, New Jersey, United States
• Memorial Sloan Kettering Cancer Commack (Limited Protocol Activities) — Commack, New York, United States
• Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison, New York, United States
• Columbia University — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale, New York, United States

Full record on ClinicalTrials.gov

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