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PD-1 Inhibitor
Targeted Drugs + Radiation Therapy for Prostate Cancer (SBRT-AMICO Trial)
Phase 2
Recruiting
Led By Catherine S. Spina, MD, PhD
Research Sponsored by Catherine Spina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Intrauterine hormone-releasing system
Surgical sterilization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3.5 years
Awards & highlights
SBRT-AMICO Trial Summary
This trial will test if combining targeted drugs and radiation therapy can extend survival & improve local control for men with hormone-sensitive prostate cancer.
Who is the study for?
Men with hormone-sensitive oligometastatic prostate cancer, confirmed by biopsy, who have a life expectancy over 12 months and are in relatively good health (ECOG 0-2). They must have had primary treatment for prostate cancer and now present with limited metastases. Participants need normal organ/marrow function, PSA levels between 1-50 ng/mL, testosterone above 125 ng/mL, and agree to effective contraception if their partners can bear children.Check my eligibility
What is being tested?
The trial is testing the combination of zimberelimab (an immune checkpoint inhibitor), etrumadenant and quemliclustat (both targeting adenosine signaling) along with targeted radiation therapy. The goal is to see if this combo improves survival without hormones, controls local tumor growth better than radiation alone, and positively affects the tumor environment.See study design
What are the potential side effects?
Potential side effects may include typical reactions from immunotherapy such as fatigue, skin reactions or autoimmune-like conditions where the body attacks its own cells. Radiation could cause localized pain or skin changes. Digestive issues or liver enzyme changes might occur due to medication.
SBRT-AMICO Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am currently using a hormone-releasing IUD.
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I have been surgically sterilized.
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I have 1-3 small, symptom-free tumors in my bones or soft tissues.
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I have undergone a procedure to prevent pregnancy permanently.
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I am 18 years old or older.
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I am able to care for myself and perform daily activities.
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My prostate cancer is confirmed by a tissue examination.
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My prostate cancer was treated with surgery, radiation, or both.
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I am using a combined hormonal birth control method.
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I use birth control that doesn't involve estrogen, like pills, shots, or implants.
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I am a man who has had a successful vasectomy and am the only partner of a woman capable of becoming pregnant.
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My female partner has had her tubes tied.
SBRT-AMICO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of Participants free of progressive disease at 6 months
Secondary outcome measures
ADT-Free Survival
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Local Control Rate, free of progression of target lesion(s) at 6 months and 12 months
+7 moreSBRT-AMICO Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment with quemliclustatm, etrumadenant, zimberelimab and SBRTExperimental Treatment4 Interventions
Subjects with metastatic prostate cancer will receive quemliclustat and etrumadenant for 4 weeks prior to metastasis-directed SBRT (Stereotactic Body Radiation Therapy). Within one week of completing SBRT, subjects will also start zimberelimab.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zimberelimab
2018
Completed Phase 1
~50
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~780
Etrumadenant
2018
Completed Phase 1
~130
Find a Location
Who is running the clinical trial?
Catherine SpinaLead Sponsor
Arcus Biosciences, Inc.Industry Sponsor
41 Previous Clinical Trials
6,043 Total Patients Enrolled
1 Trials studying Prostate Cancer
15 Patients Enrolled for Prostate Cancer
Catherine S. Spina, MD, PhDPrincipal InvestigatorColumbia University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had lung conditions like pulmonary fibrosis or pneumonia, or my CT scan shows active lung inflammation.I haven't taken any OCT2 sensitive drugs in the last 4 weeks or 5 half-lives of the drug.I haven't taken strong antibiotics in the last 2 weeks, except for prevention.I have undergone a procedure to prevent pregnancy permanently.I will not donate sperm for 6 months after my last dose of the study drugs.I cannot swallow pills.I cannot lie flat for CT scans or certain radiotherapy treatments.I have not received any live vaccines in the last 28 days.I am currently using a hormone-releasing IUD.I have been surgically sterilized.I do not have HIV, active Hepatitis C, or active Hepatitis B.I haven't had a severe infection or been hospitalized for one in the last 4 weeks.I haven't taken strong medication or substances that affect liver enzymes in the last month.I have not had severe bleeding in the last 28 days.I tested positive for hepatitis B core antibodies but do not have an active infection.I have not taken any medication that could interact with etrumadenant.I am on immunosuppressants due to an organ transplant.I haven't taken drugs that affect MATE1 in the last 4 weeks or 5 half-lives.I am a man who will use effective birth control if my partner can have children.I have 1-3 small, symptom-free tumors in my bones or soft tissues.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.I commit to complete sexual abstinence for the study duration.I have only had prostate cancer or very low-risk cancers in the last 2 years.I have only had hormone therapy for prostate cancer, not lasting more than 6 months and it was over 6 months ago.I haven't taken strong BCRP inhibitors or sensitive BCRP substrates orally in the last 4 weeks or longer.I haven't taken strong P-gp inhibitors or certain heart medications in the last 4 weeks.I am 18 years old or older.I am able to care for myself and perform daily activities.My blood tests for organ and bone marrow function are normal.My prostate cancer is confirmed by a tissue examination.I have or am at risk of having spinal cord compression.My cancer has spread to my lungs or liver with tumors larger than 1cm.I do not have brain metastases.I have a condition that affects how my body absorbs pills.My prostate cancer was treated with surgery, radiation, or both.I haven't taken strong UGT inhibitors like atazanavir in the last 4 weeks or 5 half-lives of the drug.I haven't taken any drugs that affect the liver's bile flow in the last month.I am using a combined hormonal birth control method.I use birth control that doesn't involve estrogen, like pills, shots, or implants.I am a man who has had a successful vasectomy and am the only partner of a woman capable of becoming pregnant.My female partner has had her tubes tied.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment with quemliclustatm, etrumadenant, zimberelimab and SBRT
Awards:
This trial has 1 awards, including:- 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there any possibility I could be involved in this research initiative?
"To be eligible for this trial, patients must have been diagnosed with prostate cancer and should not exceed the age of 99 or fall below 18 years old. Currently, 23 people are needed to complete enrollment requirements."
Answered by AI
Are there any available spots for participants in this trial?
"According to clinicaltrials.gov, this specific trial is no longer accepting applications as the study was last edited on 6/14/2023. However, there are presently 1259 other trials actively recruiting patients for various interventions."
Answered by AI
Does this clinical experiment accept applicants aged 75 or older?
"In order to qualify for enrollment in this trial, the patient must be between 18 and 99 years old. Conversely, there are 61 separate studies specifically designed for individuals under the age of 18 and 1257 trials intended for people over 65."
Answered by AI
Does the FDA certify that therapeutic strategies involving quemliclustatm, etrumadenant, zimberelimab and SBRT are safe?
"Our assessment of the safety profile of Treatment with quemliclustatm, etrumadenant, zimberelimab and SBRT yielded a score 2 due to its Phase 2 status. In other words, while there is data to suggest that it is safe for use in humans, no efficacy has been established yet."
Answered by AI
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