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ACTIVE NOT RECRUITING Phase 3

A Study of an Intermittent ADT Approach With Apalutamide Monotherapy in Participants With mCSPC

NCT05884398 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of the study is to determine if the intermittent use of androgen-deprivation therapy (ADT) in participants with metastatic castrate-sensitive prostate cancer (mCSPC) who reached a prostate-specific antigen (PSA) level \< 0.2 nanograms/millilitres (ng/mL) after 6 months of treatment with apalutamide and ADT combination therapy provides non-inferior radiographic progression-free survival (rPFS) and a reduced burden of hot flashes measured as 18-month percent change in severity adjusted hot flash score.

Interventions

  • DRUG Apalutamide
  • DRUG Androgen-deprivation Therapy (ADT)

Study Locations (20)

California

  • Urology Associates of Central California — Fresno
  • VA Medical Center — San Francisco
  • Sansum Clinic Pharm — Santa Barbara

New Jersey

  • MSKCC Basking Ridge — Basking Ridge
  • MSKCC Monmouth — Middletown
  • MSKCC Bergen — Montvale

Arizona

  • Del Sol Research Management, LLC — Tucson
  • Arizona Urology Specialists — Tucson

Illinois

  • Associated Urological Specialists LLC — Chicago Ridge
  • Advanced Urology Associates — Joliet

Indiana

  • Urology of Indiana — Greenwood
  • First Urology, PSC — Jeffersonville

Maryland

  • Maryland Oncology Hematology P A — Silver Spring
  • Chesapeake Urology Research Associates — Towson

Alabama

  • Urology Centers Of Alabama — Homewood

Arkansas

  • Arkansas Urology — Little Rock

Trial Details

FieldValue
Enrollment Target 420 participants
Start Date 2023-08-31
Est. Completion 2028-10-12
Phase Phase 3

Sponsor

Janssen Research & Development

442 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05884398

The ClinicalTrials.gov registry entry for NCT05884398 describes a study currently listed as active not recruiting. It is categorized as Phase 3, 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 420 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 442 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Metastatic Castrate-sensitive Prostate Cancer appearing as the primary indexed condition, and to 2 interventions — of which Apalutamide 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: NCT05884398 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, New Jersey, Arizona. 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 NCT05884398 about?

NCT05884398 is a clinical study titled "A Study of an Intermittent ADT Approach With Apalutamide Monotherapy in Participants With mCSPC". The purpose of the study is to determine if the intermittent use of androgen-deprivation therapy (ADT) in participants with metastatic castrate-sensitive prostate cancer (mCSPC) who reached a prostate-specific antigen (PSA) level \< 0.2 nanograms/millilitres (ng/mL) after 6 months of treatment with ...

What is the current status of trial NCT05884398?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 420 participants. The study started on 2023-08-31. Estimated completion is 2028-10-12.

What conditions does trial NCT05884398 study?

This clinical trial studies the following conditions: Metastatic Castrate-sensitive Prostate Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05884398?

The interventions under investigation include: Apalutamide (DRUG), Androgen-deprivation Therapy (ADT) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05884398?

This trial is sponsored by Janssen Research & Development, which has 442 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05884398 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. 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