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Hormone Therapy

Combination Therapy for Prostate Cancer

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

No Placebo-Only Group

Approved for 5 Other Conditions

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.

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

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 • NCT01926197

100%

Fatigue

100%

Aspartate aminotransferase increased

92%

Diarrhea

92%

Platelet count decreased

83%

Anemia

83%

Weight loss

83%

Alkaline phosphatase increased

83%

Nausea

75%

Pain, abdominal

67%

Decreased appetite (anorexia)

67%

Hypertension

58%

Hyperglycemia

58%

Nerve damage or injury (neuropathy)

58%

Hypokalemia

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%

Bad taste in mouth (dysgeusia)

25%

Hyponatremia

25%

Anxiety

25%

Pain

25%

Constipation

25%

Hypocalcemia

25%

Labored breathing (dyspnea)

17%

Muscle pain (myalgia)

17%

Indigestion (dyspepsia)

17%

Pain, back

17%

Flatulence

17%

General feeling of discomfort (malaise)

17%

Depression

17%

Hair loss, immune-realted (alopecia)

17%

Neutrophil count decreased

17%

Difficulty sleeping (insomnia)

17%

Oral inflammation (mucositis)

Chills

Fever

Allergic reaction

Bleed (hemorrhage), gastrointestinal

Hearing impaired

Edema, localized

Other, Creatinine decreased

Pain, flank

Muscle weakness lower limb

Drowsiness, unusual (somnolence)

Tiredness (fatigue)

Lymphedema

Thromboembolic event

Abdominal distention

Abnormal sensation in the mouth (oral dysesthesia)

Dry mouth

Gastroesophageal reflux disease

Pain, stomach

Pain, chest, non-cardiac

Lymphocyte count increased

Other, Neutrophil count increase

Other, Protein total decrease

Thrombocytopenia

Weight gain

Hypercalcemia

Hypernatremia

Dizziness

Nerve tingling (paresthesia)

Slow or slurred speech (dysarthria)

Tremor

Rash

Gastroparesis

Flu-like symptoms

Alkaline phosphatase decreased

Blood bilirubin increased

Dehydration

Nerve damage or injury (neuropathy), peripheral sensory

Confusion

Other, axilla boil

Other, hemoglobin decreased

Infusion-related reaction

Arthritis

Generalized muscle weakness

Memory impairment

Movements involuntary

Chronic kidney disease

Cataract

Other, excess in the stool (steatorrhea)

Other, stool discolored, clay color

Gamma-glutamyl transferase (GGT) increased

Hypoglycemia

Urinary incontinence

Urinary urgency

Urine discoloration

Excessive sweating (hyperhidrosis)

100%

80%

60%

40%

20%

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.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

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)

2017