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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

Must not have

History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan

Inability to swallow medications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 12 weeks for 3.5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

Exclusion Criteria

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

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I have had lung conditions like pulmonary fibrosis or pneumonia, or my CT scan shows active lung inflammation.

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I cannot swallow pills.

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I cannot lie flat for CT scans or certain radiotherapy treatments.

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I do not have HIV, active Hepatitis C, or active Hepatitis B.

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I haven't had a severe infection or been hospitalized for one in the last 4 weeks.

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I haven't taken strong medication or substances that affect liver enzymes in the last month.

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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

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I have not had severe bleeding in the last 28 days.

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I have not taken any medication that could interact with etrumadenant.

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I am on immunosuppressants due to an organ transplant.

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I haven't taken strong P-gp inhibitors or certain heart medications in the last 4 weeks.

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I have or am at risk of having spinal cord compression.

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My cancer has spread to my lungs or liver with tumors larger than 1cm.

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I do not have brain metastases.

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I have a condition that affects how my body absorbs pills.

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I haven't taken strong UGT inhibitors like atazanavir in the last 4 weeks or 5 half-lives of the drug.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 12 weeks for 3.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 12 weeks for 3.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 12 weeks for 3.5 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

Biochemical recurrence-free survival at 12-months

Secondary study objectives

Biochemical recurrence-free survival at 6-months

To assess the safety and tolerability of oligometastasis-directed SBRT + quemliclustat + etrumadenant + zimberelimab.

To estimate pain over time.

+3 more

Awards & Highlights

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: 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

Quemliclustat

2020

Completed Phase 2

~180

Zimberelimab

2020

Completed Phase 2

~230