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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study 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.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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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%
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)
8%
Other, Creatinine decreased
8%
Pain, flank
8%
Lymphedema
8%
Hearing impaired
8%
Bleed (hemorrhage), gastrointestinal
8%
Edema, localized
8%
Thromboembolic event
8%
Allergic reaction
8%
Chills
8%
Fever
8%
Drowsiness, unusual (somnolence)
8%
Tiredness (fatigue)
8%
Muscle weakness lower limb
8%
Abdominal distention
8%
Abnormal sensation in the mouth (oral dysesthesia)
8%
Dry mouth
8%
Gastroesophageal reflux disease
8%
Pain, stomach
8%
Pain, chest, non-cardiac
8%
Lymphocyte count increased
8%
Other, Neutrophil count increase
8%
Other, Protein total decrease
8%
Thrombocytopenia
8%
Weight gain
8%
Hypercalcemia
8%
Hypernatremia
8%
Dizziness
8%
Nerve tingling (paresthesia)
8%
Slow or slurred speech (dysarthria)
8%
Tremor
8%
Rash
8%
Gastroparesis
8%
Flu-like symptoms
8%
Alkaline phosphatase decreased
8%
Blood bilirubin increased
8%
Dehydration
8%
Nerve damage or injury (neuropathy), peripheral sensory
8%
Confusion
8%
Other, axilla boil
8%
Other, hemoglobin decreased
8%
Infusion-related reaction
8%
Arthritis
8%
Generalized muscle weakness
8%
Memory impairment
8%
Movements involuntary
8%
Chronic kidney disease
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
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
~2370
Gonadorelin
FDA approved
Stereotactic Body Radiotherapy (SBRT)
2016
Completed Phase 3
~580
Enzalutamide
FDA approved
Abiraterone
2012
Completed Phase 4
~2830
Atezolizumab
2017
Completed Phase 3
~5860
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,592 Total Patients Enrolled
133 Trials studying Prostate Cancer
52,074 Patients Enrolled for Prostate Cancer
Genentech, Inc.Industry Sponsor
1,539 Previous Clinical Trials
567,661 Total Patients Enrolled
17 Trials studying Prostate Cancer
6,210 Patients Enrolled for Prostate Cancer
Stand Up To CancerOTHER
51 Previous Clinical Trials
40,266 Total Patients Enrolled
1 Trials studying Prostate Cancer
30 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.
- 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.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities to become involved in this research endeavor?
"Clinicaltrials.gov shows that this medical experiment has been actively seeking out volunteers since its inception on March 3rd 2020 and the most recent edit was made November 18th 2022."
Answered by AI
To what extent does Stereotactic Body Radiotherapy (SBRT) threaten the safety of patients?
"Through our internal assessment, we gave Stereotactic Body Radiotherapy (SBRT) a safety rating of 2. This is based on the fact that this Phase 2 trial has generated some data related to security but no information yet confirming its efficacy."
Answered by AI
To what medical issues is Stereotactic Body Radiotherapy (SBRT) predominantly applied?
"Stereotactic Body Radiotherapy (SBRT) is an effective treatment for thyroiditis, ulcerative colitis, as well as varicella-zoster virus acute retinal necrosis."
Answered by AI
Are there any secondary investigations into the efficacy of Stereotactic Body Radiotherapy (SBRT)?
"At present, SBRT is being studied in 762 trials globally. Of these trials, 189 are currently in the third phase of their clinical experiments. The main hub for such research is Duarte, California; however, there exist 40098 different sites where patients can receive this form of radiation therapy."
Answered by AI
What is the proposed size of this clinical trial's population?
"Affirmative. According to the information posted on clinicaltrials.gov, this research project is currently seeking volunteers. The trial was initially announced on March 3rd 2020 and has been modified as recently as November 18th 2022. 44 patients are needed across 10 sites in order to progress with the study."
Answered by AI
How many settings are the research trials being conducted in?
"Ten clinical trial sites are available for this medical study. Several of them belong to the Memorial Sloan Kettering Cancer Center, such as Basking Ridge and Montvale in New jersey, while other locations exist across North America."
Answered by AI
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