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NCT03821246 · ClinicalTrials.gov registry record · Phase 2
Neoadjuvant Atezolizumab-Based Combination Therapy in Men With Localized Prostate Cancer Prior to Radical Prostatectomy
A Phase 2 study of Prostate Cancer and Prostate Adenocarcinoma, sponsored by David Oh.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 68
- Enrollment target
- 2
- Study locations
NCT03821246: Recruiting Phase 2 study of Prostate Cancer and Prostate Adenocarcinoma, sponsored by David Oh.
NCT03821246 is a Phase 2 study of Prostate Cancer and Prostate Adenocarcinoma that is actively recruiting participants, run by David Oh. The registered enrollment target is 68 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (89% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03821246, a Phase 2 study of Prostate Cancer and Prostate Adenocarcinoma, is actively recruiting participants, sponsored by David Oh.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 68 participants
- Enrollment target
- 2
- Study locations
Study Summary
This phase II trial studies how well atezolizumab works alone or in combination with etrumadenant or tocilizumab in treating men with localized prostate cancer before radical prostatectomy. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Androgens can cause the growth of prostate cancer cells. IL-6 is expressed by prostate cancer and within the tumor microenvironment and shown to enhance prostate cancer and disease progression. Treatment with an anti-IL-6 antibody such as tocilizumab may inhibit cancer progression. Giving atezolizumab in combination with etrumadenant or tocilizumab may work better in treating prostate cancer.
Primary Outcome
A positive response is defined as a ≥40% increase in the number of infiltrating cluster of differentiation 3 (CD3) + T cells between the pre-treatment biopsy at baseline and the post-treatment RP specimen. Thus, a negative response is a \<40% increase. The primary endpoint will include all enrolled subjects who receive at least 1 dose of study treatment and undergo RP. Analysis of the primary endpoint will be performed for each cohort independently
Conditions Studied
Interventions
- DRUG Atezolizumab
- DRUG Tocilizumab
- DRUG Etrumadenant
Study Locations (2)
California
- University of California, San Francisco - San Francisco
Missouri
- Alvin J. Siteman Cancer Center at Washington University - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2019-10-30 |
| Est. Completion | 2026-04-30 |
| Phase | Phase 2 |
What NCT03821246 shows while recruiting
NCT03821246 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (89% lower).
The record links to 3 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 3 interventions - of which Atezolizumab is the first listed.
NCT03821246 reports a single indexed study location in California, Missouri.
Frequently Asked Questions
What is clinical trial NCT03821246 about?
NCT03821246 is a clinical study titled "Neoadjuvant Atezolizumab-Based Combination Therapy in Men With Localized Prostate Cancer Prior to Radical Prostatectomy". This phase II trial studies how well atezolizumab works alone or in combination with etrumadenant or tocilizumab in treating men with localized prostate cancer before radical prostatectomy. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the c...
What is the current status of trial NCT03821246?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 68 participants. The study started on 2019-10-30. Estimated completion is 2026-04-30.
What conditions does trial NCT03821246 study?
This clinical trial studies the following conditions: Prostate Cancer, Prostate Adenocarcinoma, Localized Prostate Cancer.
What interventions are being tested in trial NCT03821246?
The interventions under investigation include: Atezolizumab (DRUG), Tocilizumab (DRUG), Etrumadenant (DRUG).
Who is sponsoring clinical trial NCT03821246?
This trial is sponsored by David Oh, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03821246 being conducted?
This trial has 2 study locations across California, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prostate Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03821246's enrollment target sits among peer trials
68 404th of 735 higher than 329 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer 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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