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NCT03899987 · ClinicalTrials.gov registry record · Phase 2
Aspirin and Rintatolimod With or Without Interferon-alpha 2b in Treating Patients With Prostate Cancer Before Surgery
A Phase 2 study of Prostate Adenocarcinoma and Stage III Prostate Cancer AJCC v8, sponsored by Roswell Park Cancer Institute.
- Active
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT03899987: Active Phase 2 study of Prostate Adenocarcinoma and Stage III Prostate Cancer AJCC v8, sponsored by Roswell Park Cancer Institute.
NCT03899987 is a Phase 2 study of Prostate Adenocarcinoma and Stage III Prostate Cancer AJCC v8 that is active but no longer recruiting, run by Roswell Park Cancer Institute. The registered enrollment target is 12 participants, below the 218-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03899987, a Phase 2 study of Prostate Adenocarcinoma and Stage III Prostate Cancer AJCC v8, is active but no longer recruiting, sponsored by Roswell Park Cancer Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies how well enteric-coated (EC) aspirin and rintatolimod with or without interferon-alpha 2b work in treating patients with prostate cancer before surgery. EC Aspirin may help to keep the prostate cancer from coming back. Rintatolimod may stimulate the immune system and interfere with the ability of tumor cells to grow and spread. Interferon-alpha 2b may improve the body's natural response to infections and may slow tumor growth. It is not yet known how well rintatolimod, EC aspirin, and interferon-alpha 2b work in treating patients with prostate cancer undergoing surgery.
Primary Outcome
This will be assessed by the increase in the total number of tumor infiltrating CD8+ T cells in the radical prostatectomy specimen (measured as cell density of CD8+ cell by immunohistochemistry), comparing Arm A versus Arm B versus Arm C. Will be natural log transformed prior to analysis. The primary analysis will consist of testing the single degree of freedom planned contrast at alpha = .10 that the 3 treatment means are in the ratio of 3:2:1 (contrast coefficients 3, -2, -1) for groups A, B a
Conditions Studied
Interventions
- PROCEDURE Radical Prostatectomy
- BIOLOGICAL Recombinant Interferon Alfa-2b
- DRUG EC Aspirin
- DRUG Rintatolimod
Study Locations (1)
New York
- Roswell Park Cancer Institute - Buffalo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2019-11-29 |
| Est. Completion | 2026-11-29 |
| Phase | Phase 2 |
What the registry record for NCT03899987 still lists
NCT03899987 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 218-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (94% lower).
The record links to 10 conditions, with Prostate Adenocarcinoma appearing as the primary indexed condition, and to 4 interventions - of which Radical Prostatectomy is the first listed.
NCT03899987 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT03899987 about?
NCT03899987 is a clinical study titled "Aspirin and Rintatolimod With or Without Interferon-alpha 2b in Treating Patients With Prostate Cancer Before Surgery". This phase II trial studies how well enteric-coated (EC) aspirin and rintatolimod with or without interferon-alpha 2b work in treating patients with prostate cancer before surgery. EC Aspirin may help to keep the prostate cancer from coming back. Rintatolimod may stimulate the immune system and inte...
What is the current status of trial NCT03899987?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2019-11-29. Estimated completion is 2026-11-29.
What conditions does trial NCT03899987 study?
This clinical trial studies the following conditions: Prostate Adenocarcinoma, Stage III Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage I Prostate Cancer AJCC v8, Stage IIC Prostate Cancer AJCC v8.
What interventions are being tested in trial NCT03899987?
The interventions under investigation include: Radical Prostatectomy (PROCEDURE), Recombinant Interferon Alfa-2b (BIOLOGICAL), EC Aspirin (DRUG), Rintatolimod (DRUG).
Who is sponsoring clinical trial NCT03899987?
This trial is sponsored by Roswell Park Cancer Institute, which has 365 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03899987 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
Similar trials for Prostate Adenocarcinoma
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 NCT03899987's enrollment target sits among peer trials
12 93rd of 99 higher than 6 of 99 other Prostate Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Adenocarcinoma 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.
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