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ACTIVE NOT RECRUITING Phase 2

Testing the Effects of Low Dose Apalutamide on Prostate-Specific Antigen (PSA) Levels in Men Scheduled for Removal of the Prostate Gland

NCT04530552 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 34 participants
Start Date 2021-07-23
Est. Completion 2027-01-31
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

2,390 total trials

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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04530552 reports 5 study locations spanning 4 distinct geographic areas — top geographies include Maryland, Arizona, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04530552?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Quality-of-Life Assessment (OTHER), Apalutamide (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04530552?

This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial