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NCT04530552 · ClinicalTrials.gov registry record · Phase 2
Testing the Effects of Low Dose Apalutamide on Prostate-Specific Antigen (PSA) Levels in Men Scheduled for Removal of the Prostate Gland
A Phase 2 study of Prostate Adenocarcinoma and Stage II Prostate Cancer AJCC v8, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 34
- Enrollment target
- 5
- Study locations
NCT04530552 is a Phase 2 study of Prostate Adenocarcinoma and Stage II Prostate Cancer AJCC v8 that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 34 participants, below the 218-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (84% lower). The trial reports 5 study locations across 4 states.
The verdict
NCT04530552, a Phase 2 study of Prostate Adenocarcinoma and Stage II Prostate Cancer AJCC v8, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 34 participants
- Enrollment target
- 5
- Study locations
Study Summary
Apalutamide is an anti-androgen that blocks the effect of testosterone on prostate cancer growth. This phase IIa trial is designed to determine whether very low doses of apalutamide, given for 3 to 4 weeks before prostate surgery to men with prostate cancer confined to the prostate gland, reduces plasma levels of PSA (a biomarker of apalutamide's ability to block testosterone). If low dose apalutamide lowers PSA levels in this setting, further study of this agent in men with localized prostate cancer who wish to delay definitive therapy with surgery or radiation may be warranted.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- OTHER Quality-of-Life Assessment
- DRUG Apalutamide
Study Locations (5)
Maryland
- Johns Hopkins University/Sidney Kimmel Cancer Center - Baltimore
- NCI - Center for Cancer Research - Bethesda
Arizona
- University of Arizona Cancer Center - Prevention Research Clinic - Tucson
California
- USC / Norris Comprehensive Cancer Center - Los Angeles
District of Columbia
- George Washington University Medical Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2021-07-23 |
| Est. Completion | 2027-01-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04530552
The ClinicalTrials.gov registry entry for NCT04530552 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 218-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (84% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Prostate Adenocarcinoma appearing as the primary indexed condition, and to 3 interventions - of which Biospecimen Collection is the first listed.
NCT04530552 reports 5 study locations spanning 4 distinct geographic areas - top geographies include Maryland, Arizona, California.
Frequently Asked Questions
What is clinical trial NCT04530552 about?
NCT04530552 is a clinical study titled "Testing the Effects of Low Dose Apalutamide on Prostate-Specific Antigen (PSA) Levels in Men Scheduled for Removal of the Prostate Gland". Apalutamide is an anti-androgen that blocks the effect of testosterone on prostate cancer growth. This phase IIa trial is designed to determine whether very low doses of apalutamide, given for 3 to 4 weeks before prostate surgery to men with prostate cancer confined to the prostate gland, reduces pl...
What is the current status of trial NCT04530552?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2021-07-23. Estimated completion is 2027-01-31.
What conditions does trial NCT04530552 study?
This clinical trial studies the following conditions: Prostate Adenocarcinoma, Stage II Prostate Cancer AJCC v8, Stage I Prostate Cancer AJCC v8, Localized Prostate Carcinoma.
What interventions are being tested in trial NCT04530552?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Quality-of-Life Assessment (OTHER), Apalutamide (DRUG).
Who is sponsoring clinical trial NCT04530552?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04530552 being conducted?
This trial has 5 study locations across Arizona, California, District of Columbia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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