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NCT05915442 · ClinicalTrials.gov registry record · Phase 2
Adenosine Signaling Modulation and Immune Checkpoint Inhibition With Hormone Sensitive Oligometastatic Prostate Cancer
A Phase 2 study of Oligometastatic Prostate Cancer, sponsored by Catherine Spina.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 23
- Enrollment target
- 1
- Study location
NCT05915442: Recruiting Phase 2 study of Oligometastatic Prostate Cancer, sponsored by Catherine Spina.
NCT05915442 is a Phase 2 study of Oligometastatic Prostate Cancer that is actively recruiting participants, run by Catherine Spina. The registered enrollment target is 23 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05915442, a Phase 2 study of Oligometastatic Prostate Cancer, is actively recruiting participants, sponsored by Catherine Spina.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 23 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will evaluate the safety and effectiveness of a combination of study drugs including zimberelimab, etrumadenant, and quemliclustat in combination with metastasis-directed irradiation in men with hormone sensitive oligometastatic prostate cancer. The study aims to test the hypothesis that targeted inhibition of the adenosine signaling axis (quemliclustat (CD73 antagonist) + etrumadenant (A2AR/A2BR antagonist)) and immune checkpoint inhibition (zimberelimab, α-PD-1) in combination with metastasis-directed stereotactic body radiation therapy (SBRT) will improve local control, progression-free survival (PFS), and hormone therapy-free survival and mitigate immunosuppressive changes to the tumor microenvironment (TME), compared to SBRT alone.
Primary Outcome
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.
Conditions Studied
Interventions
- RADIATION Stereotactic Body Radiation Therapy
- DRUG Zimberelimab
- DRUG Quemliclustat
- DRUG Etrumadenant
Study Locations (1)
New York
- Columbia University Irving Medical Center / NewYork-Presbyterian Hospital - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2023-07-01 |
| Est. Completion | 2028-12 |
| Phase | Phase 2 |
What NCT05915442 shows while recruiting
NCT05915442 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Oligometastatic Prostate Cancer appearing as the primary indexed condition, and to 4 interventions - of which Stereotactic Body Radiation Therapy is the first listed.
NCT05915442 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT05915442 about?
NCT05915442 is a clinical study titled "Adenosine Signaling Modulation and Immune Checkpoint Inhibition With Hormone Sensitive Oligometastatic Prostate Cancer". This study will evaluate the safety and effectiveness of a combination of study drugs including zimberelimab, etrumadenant, and quemliclustat in combination with metastasis-directed irradiation in men with hormone sensitive oligometastatic prostate cancer. The study aims to test the hypothesis that...
What is the current status of trial NCT05915442?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2023-07-01. Estimated completion is 2028-12.
What conditions does trial NCT05915442 study?
This clinical trial studies the following conditions: Oligometastatic Prostate Cancer.
What interventions are being tested in trial NCT05915442?
The interventions under investigation include: Stereotactic Body Radiation Therapy (RADIATION), Zimberelimab (DRUG), Quemliclustat (DRUG), Etrumadenant (DRUG).
Who is sponsoring clinical trial NCT05915442?
This trial is sponsored by Catherine Spina, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05915442 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05915442's enrollment target sits among peer trials
23 1784th of 2000 higher than 212 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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