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Adenosine Signaling Modulation and Immune Checkpoint Inhibition for Oligometastatic Prostate Cancer

This study is looking at a new combination treatment for men with hormone-sensitive oligometastatic prostate cancer (cancer that has spread to a few, limited areas). It combines three study drugs – zimberelimab, etrumadenant, and quemliclustat – with stereotactic body radiation therapy (SBRT), a focused type of radiation. The study aims to see if this combination can improve how long patients live without their cancer getting worse and how long they can go without needing hormone therapy, compared to SBRT alone. You might be able to join if you are a man aged 18-99 with prostate cancer that has spread to 1-3 small areas in the last 6 months, and your PSA (prostate-specific antigen) is above zero. The study is currently unclear on its recruitment status and plans to enroll 23 participants. Success will be measured by how many participants are free from biochemical recurrence (a rise in PSA) at 12 months.

Study design
This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 23 male participants.
What's involved
You would receive quemliclustat intravenously (IV) every two weeks, etrumadenant orally once a day, and zimberelimab IV every two weeks. You would also receive SBRT starting about 4 weeks after beginning etrumadenant and quemliclustat.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 12 months, which suggests participants will be followed for at least this long to assess biochemical recurrence-free survival.

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NCT05915442

Adenosine Signaling Modulation and Immune Checkpoint Inhibition With Hormone Sensitive Oligometastatic Prostate Cancer

Recruiting
PHASE2Ages 18–99InterventionalTreatment
Catherine Spina
~23 participants
Updated 2025-05-20 on ClinicalTrials.gov
What's tested:QuemliclustatEtrumadenantZimberelimabStereotactic Body Radiation Therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Biochemical recurrence-free survival at 12-months
Measured over 12 months

Conditions

Oligometastatic Prostate Cancer

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Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Catherine S. Spina, MD, PhD · PRINCIPAL_INVESTIGATOR · Columbia University

Who to contact

Catherine S. Spina, MD, PhD
[email protected]
212-305-7406
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

leukocytes ≥3,000/mcL
absolute neutrophil count ≥1,500/mcL
platelets ≥100,000/mcL
total bilirubin within normal institutional limits
aspartate transaminase (AST)(serum glutamic-oxaloacetic transaminase (SGOT))/alanine transaminase (ALT)(serum glutamic-pyruvic transaminase (SGPT) ) ≤2.5 × institutional upper limit of normal creatinine, within normal institutional limits 11. Male participants with female partners of childbearing potential are required to use highly effective contraceptive measures which include condom use. A man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy. A female partner of is considered a woman of childbearing potential (WOCBP) following menarche and until becoming postmenopausal unless permanently sterile.
Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle-stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal
Progestogen only hormonal contraception associated with inhibition of ovulation: oral, injectable, implantable
Intrauterine device
Intrauterine hormone-releasing system
Surgical sterilization
The male participant is vasectomized (with documented medical confirmation of surgical success) and is the sole sexual partner of the WOCBP participant
Female partner of the male participant has undergone bilateral tubal ligation
Complete sexual abstinence defined as refraining from heterosexual intercourse during the entire period of risk associated with study treatment. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant. 12. Male participants should refrain from donating sperm for 180 days after the last dose of the study drugs. 13. Patient must have the ability to understand and the willingness to sign written informed consent.

What this trial measures

  • Biochemical recurrence-free survival at 12-months12 months

    Biochemical recurrence is defined as a 0.2 ng/ml increase in PSA above the post-SBRT PSA nadir. Patient will be followed until biochemical recurrence, death, or end of study, whichever comes first. Patients who are alive and biochemical recurrence free will be censored at the last PSA measurement date.