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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: Active Phase 2 study of Prostate Adenocarcinoma and Stage II Prostate Cancer AJCC v8, sponsored by National Cancer Institute (NCI).
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The proportion of participants with \>= 25% decline in PSA levels (from baseline to end-of-intervention) will be reported along with the 97.5% credible interval for the response rate based on the posterior distribution of the response rate derived from a non-informative prior for the response rate, which is consistent with the Bayesian approach.
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 |
What the registry record for NCT04530552 still lists
NCT04530552 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 218-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (84% lower).
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 lists 5 locations in 4 states (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.
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 NCT04530552's enrollment target sits among peer trials
34 75th of 99 higher than 24 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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