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

NCT04262154 | Active Not Recruiting Phase 2 Results FDA Drug

• 1 other identifier: 19-461
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Metastatic Prostate Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Failure-free Rate at 2 Years

  Failure is defined as: biochemical failure, radiographic progression defined by PCWG3, or death from any cause.

  2 years

Study Arms (1)

Metastatic Prostate Cancer

EXPERIMENTAL

Participants 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.Group 1 and 2. The first 20 patients enrolled will be in Group 1 and the remaining patients (and those who are already on a GnRH analog) will be assigned to Group 2. All study participants will receive treatment with atezolizumab, abiraterone acetate, prednisone, GnRH analog, and SBRT, at the same doses.

Drug: Atezolizumab; Drug: Abiraterone; Drug: Prednisone; Drug: GnRH analog; Radiation: Stereotactic Body Radiotherapy (SBRT); Drug: Enzalutamide; Other: Follow up

Interventions

Atezolizumab DRUG

Atezolizumab 1200 mg IV over 60 minutes every 3 weeks

Metastatic Prostate Cancer

Abiraterone DRUG

Abiraterone 1000 mg daily

Metastatic Prostate Cancer

Prednisone DRUG

Prednisone 5 mg daily

Metastatic Prostate Cancer

GnRH analog DRUG

Any GnRH analog that is commercially available, injectable, and long acting analog of the native LHRH peptide and is administered to subjects via intramuscular injection. For this study, any GnRH analog can be used and thee manufacturer's instructions for dose and frequency should be followed.

Metastatic Prostate Cancer

Stereotactic Body Radiotherapy (SBRT) RADIATION

Intensity-modulated, image-guided, ultra-hypofractionated external beam radiotherapy (7.25-7.5 Gy x 5 to prostate and seminal vesicles QOD) will begin around 12 weeks (at Cycle 5 Day 1 (+/-5 days)

Metastatic Prostate Cancer

Enzalutamide DRUG

160 mg once daily

Metastatic Prostate Cancer

Follow up OTHER

Subjects who discontinue study treatment for reasons other than progression will be followed every 6 months (+/- 4 weeks) until a documented progression event (i.e., PSA, radiographic, or clinical progression). After a documented progressionevent (whether on treatment or during follow up), subjects will continue to be followed every 6 months (+/- 4 weeks) for overall survival via chart review and/or telephone call.

Metastatic Prostate Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Genentech, Inc.: collaborator
• Stand Up To Cancer: collaborator

Study Sites (8)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Cancer Commack (Limited Protocol Activities)

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, 11553, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

atezolizumab; abiraterone; Prednisone; Gonadotropin-Releasing Hormone; Radiosurgery; enzalutamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Dr. Dana Rathkopf, MD
• Organization: Memorial Sloan Kettering Cancer Center

rathkopd@MSKCC.ORG

646-422-4379

Study Officials

• Dana Rathkopf, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2020
• First Posted: February 10, 2020
• Study Start: March 3, 2020
• Primary Completion: July 7, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 24, 2026
• Results First Posted: April 24, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

US (8)