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NCT03412396 · ClinicalTrials.gov registry record · Phase 2
Apalutamide in Treating Patients With Prostate Cancer Before Radical Prostatectomy
A Phase 2 study of Prostate Adenocarcinoma and Stage IIB Prostate Cancer AJCC v8, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 45
- Enrollment target
- 1
- Study location
NCT03412396: Active Phase 2 study of Prostate Adenocarcinoma and Stage IIB Prostate Cancer AJCC v8, sponsored by M.D. Anderson Cancer Center.
NCT03412396 is a Phase 2 study of Prostate Adenocarcinoma and Stage IIB Prostate Cancer AJCC v8 that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 45 participants, below the 218-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03412396, a Phase 2 study of Prostate Adenocarcinoma and Stage IIB Prostate Cancer AJCC v8, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 45 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies how well apalutamide works in treating patients with prostate cancer before radical prostatectomy. Androgen can cause the growth of prostate cancer cells. Hormone therapy using apalutamide may fight prostate cancer by lowering the amount of androgen the body makes and may make it less likely for patients to receive radiation therapy after surgery.
Primary Outcome
To determine whether 6 months (24 weeks) of neoadjuvant apalutamide prior to prostatectomy for intermediate risk prostate cancer results in a reduction of surgical pathology features at risk of pelvic RT, defined as pT3a, pT3b stage, N1 and/or positive surgical margin. All patients who receive at least 9 weeks of neoadjuvant therapy of apalutamide and undergo radical prostatectomy will be evaluable for the primary endpoint.
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- DRUG Apalutamide
- PROCEDURE Radical Prostatectomy
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2018-03-22 |
| Est. Completion | 2026-03-30 |
| Phase | Phase 2 |
What the registry record for NCT03412396 still lists
NCT03412396 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 218-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (79% lower).
The record links to 2 conditions, with Prostate Adenocarcinoma appearing as the primary indexed condition, and to 3 interventions - of which Quality-of-Life Assessment is the first listed.
NCT03412396 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03412396 about?
NCT03412396 is a clinical study titled "Apalutamide in Treating Patients With Prostate Cancer Before Radical Prostatectomy". This phase II trial studies how well apalutamide works in treating patients with prostate cancer before radical prostatectomy. Androgen can cause the growth of prostate cancer cells. Hormone therapy using apalutamide may fight prostate cancer by lowering the amount of androgen the body makes and may...
What is the current status of trial NCT03412396?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2018-03-22. Estimated completion is 2026-03-30.
What conditions does trial NCT03412396 study?
This clinical trial studies the following conditions: Prostate Adenocarcinoma, Stage IIB Prostate Cancer AJCC v8.
What interventions are being tested in trial NCT03412396?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Apalutamide (DRUG), Radical Prostatectomy (PROCEDURE).
Who is sponsoring clinical trial NCT03412396?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03412396 being conducted?
This trial has 1 study location across Texas. 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 NCT03412396's enrollment target sits among peer trials
45 66th of 99 higher than 34 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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