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Hormone Therapy
Combination Therapy for Prostate Cancer
New York, NY
Phase 2
Waitlist Available
Led By Dana Rathkopf, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Biopsy-proven adenocarcinoma of the prostate
Males 18 years of age and above
Must not have
Known or suspected brain metastasis or active leptomeningeal disease
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group
Summary
This trial is testing a new treatment for prostate cancer that has spread. The new treatment is a combination of drugs and radiation, and researchers want to see if it is safe and effective.
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Who is the study for?
Men over 18 with untreated metastatic hormone-sensitive prostate cancer, who can consent to treatment and have normal organ function. They must be eligible for SBRT, have an ECOG status of 0 or 1, and agree to use birth control during the study. Exclusions include HIV/HBV/HCV infection, large prostate volume (>80cc), certain allergies, other recent cancers or treatments, uncontrolled conditions like hypertension or infections.Check my eligibility
What is being tested?
The trial is testing if adding atezolizumab (an immunotherapy drug) and SBRT to standard treatment with abiraterone acetate (a hormonal therapy), prednisone (a steroid), and Lupron® improves outcomes in men with newly diagnosed metastatic prostate cancer compared to standard treatment alone.See study design
What are the potential side effects?
Possible side effects include immune-related reactions affecting organs, fatigue, digestive issues like nausea or diarrhea from prednisone; high blood pressure from abiraterone; infusion reactions from atezolizumab; skin irritation from radiation therapy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My prostate cancer was confirmed through a biopsy.
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I am a male and 18 years old or older.
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I am fully active or can carry out light work.
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My prostate cancer has spread and hasn't been treated yet.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have brain metastasis or active leptomeningeal disease.
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I have not received a live vaccine recently and do not plan to during or shortly after treatment.
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I have or had an autoimmune disease or immune deficiency.
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I have pain from my cancer that isn't relieved by treatment.
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I have high calcium levels in my blood that are causing symptoms.
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I am allergic to abiraterone or prednisone.
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I haven't had major surgery in the last 4 weeks and don't expect to need one during the study.
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My high blood pressure is not under control.
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I have previously been treated with specific immune therapies.
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I have an active hepatitis B infection.
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My prostate is larger than 80 cubic centimeters.
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I have had lung conditions like pulmonary fibrosis or pneumonitis.
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I haven't taken any immune-weakening drugs in the last 2 weeks and don't expect to need any during the study.
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I have active tuberculosis.
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I have had issues with my adrenal glands.
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My prostate cancer is diagnosed as pure small cell carcinoma.
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I frequently need procedures to remove excess fluid from my chest or abdomen.
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I have had a previous transplant of stem cells or an organ.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Failure-free rate at 2 years
Side effects data
From 2022 Phase 3 trial • 27 Patients • NCT01926197100%
Fatigue
100%
Aspartate aminotransferase increased
92%
Diarrhea
92%
Platelet count decreased
83%
Anemia
83%
Alkaline phosphatase increased
83%
Weight loss
83%
Nausea
75%
Pain, abdominal
67%
Hypertension
67%
Decreased appetite (anorexia)
58%
Hyperglycemia
58%
Hypokalemia
58%
Nerve damage or injury (neuropathy)
50%
Alanine aminotransferase increased
50%
White blood cell decreased
50%
Hypoalbuminemia
42%
White blood cell (WBC) count elevated (leukocytosis)
42%
Lymphocyte count decreased
33%
Bloating
33%
Edema, peripheral
25%
Vomiting
25%
Hyponatremia
25%
Bad taste in mouth (dysgeusia)
25%
Anxiety
25%
Pain
25%
Constipation
25%
Hypocalcemia
25%
Labored breathing (dyspnea)
17%
Flatulence
17%
Indigestion (dyspepsia)
17%
General feeling of discomfort (malaise)
17%
Muscle pain (myalgia)
17%
Pain, back
17%
Depression
17%
Hair loss, immune-realted (alopecia)
17%
Neutrophil count decreased
17%
Difficulty sleeping (insomnia)
17%
Oral inflammation (mucositis)
8%
Pain, stomach
8%
Abdominal distention
8%
Abnormal sensation in the mouth (oral dysesthesia)
8%
Bleed (hemorrhage), gastrointestinal
8%
Hearing impaired
8%
Dry mouth
8%
Gastroesophageal reflux disease
8%
Gastroparesis
8%
Chills
8%
Edema, localized
8%
Fever
8%
Flu-like symptoms
8%
Pain, chest, non-cardiac
8%
Allergic reaction
8%
Alkaline phosphatase decreased
8%
Blood bilirubin increased
8%
Lymphocyte count increased
8%
Other, Creatinine decreased
8%
Other, Neutrophil count increase
8%
Other, Protein total decrease
8%
Thrombocytopenia
8%
Weight gain
8%
Dehydration
8%
Hypercalcemia
8%
Hypernatremia
8%
Muscle weakness lower limb
8%
Pain, flank
8%
Dizziness
8%
Drowsiness, unusual (somnolence)
8%
Nerve damage or injury (neuropathy), peripheral sensory
8%
Nerve tingling (paresthesia)
8%
Slow or slurred speech (dysarthria)
8%
Tiredness (fatigue)
8%
Tremor
8%
Confusion
8%
Chronic kidney disease
8%
Other, axilla boil
8%
Rash
8%
Lymphedema
8%
Thromboembolic event
8%
Other, hemoglobin decreased
8%
Infusion-related reaction
8%
Arthritis
8%
Generalized muscle weakness
8%
Memory impairment
8%
Movements involuntary
8%
Cataract
8%
Other, excess in the stool (steatorrhea)
8%
Other, stool discolored, clay color
8%
Gamma-glutamyl transferase (GGT) increased
8%
Hypoglycemia
8%
Urinary incontinence
8%
Urinary urgency
8%
Urine discoloration
8%
Excessive sweating (hyperhidrosis)
100%
80%
60%
40%
20%
0%
Study treatment Arm
Modified FOLFIRINOX
Modified FOLFIRINOX Plus Stereotactic Body Radiotherapy
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Metastatic Prostate CancerExperimental Treatment7 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prednisone
2014
Completed Phase 4
~2500
Gonadorelin
FDA approved
Stereotactic Body Radiotherapy (SBRT)
2016
Completed Phase 3
~1040
Enzalutamide
FDA approved
Abiraterone
2012
Completed Phase 4
~4480
Atezolizumab
2016
Completed Phase 3
~5860
Find a Location
Closest Location:Memoral Sloan Kettering Basking Ridge (Limited Protocol Activities)· Basking Ridge, NJ· 449 miles
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,996 Previous Clinical Trials
602,317 Total Patients Enrolled
135 Trials studying Prostate Cancer
51,638 Patients Enrolled for Prostate Cancer
Genentech, Inc.Industry Sponsor
1,577 Previous Clinical Trials
570,992 Total Patients Enrolled
17 Trials studying Prostate Cancer
6,168 Patients Enrolled for Prostate Cancer
Stand Up To CancerOTHER
52 Previous Clinical Trials
40,062 Total Patients Enrolled
1 Trials studying Prostate Cancer
30 Patients Enrolled for Prostate Cancer
Dana Rathkopf, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
5 Previous Clinical Trials
99 Total Patients Enrolled
4 Trials studying Prostate Cancer
90 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My prostate cancer was confirmed through a biopsy.I haven't had major heart problems in the last 6 months.I have brain metastasis or active leptomeningeal disease.I haven't had any cancer except low-risk types in the last 3 years.I have not received a live vaccine recently and do not plan to during or shortly after treatment.I have or had an autoimmune disease or immune deficiency.I have pain from my cancer that isn't relieved by treatment.I have high calcium levels in my blood that are causing symptoms.I don't have any health issues that would make it unsafe for me to take a new drug.I am allergic to abiraterone or prednisone.I am a male and 18 years old or older.I haven't had major surgery in the last 4 weeks and don't expect to need one during the study.My high blood pressure is not under control.I am fully active or can carry out light work.I have previously been treated with specific immune therapies.I have an active hepatitis B infection.My organ functions are normal as per recent tests.My prostate is larger than 80 cubic centimeters.I haven't taken any immune-boosting drugs in the last 4 weeks or 5 half-lives before starting the study treatment.I have had lung conditions like pulmonary fibrosis or pneumonitis.My prostate cancer has spread and hasn't been treated yet.I haven't taken any immune-weakening drugs in the last 2 weeks and don't expect to need any during the study.I have active tuberculosis.I have not taken any strong antibiotics in the last 2 weeks.I have had issues with my adrenal glands.My prostate cancer is diagnosed as pure small cell carcinoma.I have not had a severe infection in the last 4 weeks.I am eligible for targeted radiation therapy as per my hospital's rules.I frequently need procedures to remove excess fluid from my chest or abdomen.I have had a previous transplant of stem cells or an organ.
Research Study Groups:
This trial has the following groups:- Group 1: Metastatic Prostate Cancer
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.