A Study of an Intermittent ADT Approach With Apalutamide Monotherapy in Participants With mCSPC
Public ClinicalTrials.gov record NCT05884398. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Open-label, Randomized, Prospective Study of Apalutamide With Continued Versus Intermittent Androgen-Deprivation Therapy (ADT) Following PSA Response in Participants With Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05884398
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 420 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 31, 2023 (Actual)
- Primary completion
- Oct 12, 2026 (Estimated)
- Completion
- Oct 12, 2028 (Estimated)
- Last update posted
- Sep 25, 2026
2023 – 2028
United States locations
- U.S. sites
- 46
- U.S. states
- 19
- U.S. cities
- 40
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Urology Centers Of Alabama | Homewood | Alabama | 35209 | — |
| Del Sol Research Management, LLC | Tucson | Arizona | 85715 | — |
| Arizona Urology Specialists | Tucson | Arizona | 85741 | — |
| Arkansas Urology | Little Rock | Arkansas | 72211 | — |
| Urology Associates of Central California | Fresno | California | 93720 | — |
| VA Medical Center | San Francisco | California | 94121 | — |
| Sansum Clinic Pharm | Santa Barbara | California | 93105 | — |
| Colorado Clinical Research | Lakewood | Colorado | 80228 | — |
| Advanced Urology Institute | Daytona Beach | Florida | 32114 | — |
| Associated Urological Specialists LLC | Chicago Ridge | Illinois | 60415 | — |
| Advanced Urology Associates | Joliet | Illinois | 60431 | — |
| Urology of Indiana | Greenwood | Indiana | 46143 | — |
| First Urology, PSC | Jeffersonville | Indiana | 47130 | — |
| Maryland Oncology Hematology P A | Silver Spring | Maryland | 20904 | — |
| Chesapeake Urology Research Associates | Towson | Maryland | 21204 | — |
| Michigan Institute of Urology | Troy | Michigan | 48084 | — |
| MSKCC Basking Ridge | Basking Ridge | New Jersey | 07920 | — |
| MSKCC Monmouth | Middletown | New Jersey | 07748 | — |
| MSKCC Bergen | Montvale | New Jersey | 07645 | — |
| MSKCC Commack | Commack | New York | 11725 | — |
| MSKCC Westchester | Harrison | New York | 10604 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| Associated Medical Professionals | Syracuse | New York | 13210 | — |
| MSKCC Nassau Regional Cancer Center | Uniondale | New York | 11553 | — |
| TriState Urologic Services PSC Inc. DBA The Urology Group | Cincinnati | Ohio | 45212 | — |
| Central Ohio Urology Group | Gahanna | Ohio | 43230 | — |
| Helios Clinical Research, LLC | Middleburg Heights | Ohio | 44130 | — |
| Northwest Cancer Specialists PC | Tigard | Oregon | 97223 | — |
| Centers for Advanced Urology LLC d b a MidLantic Urology | Bala-Cynwyd | Pennsylvania | 19004 | — |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15232 | — |
| VA Pittsburgh | Pittsburgh | Pennsylvania | 15240 | — |
| The Conrad Pearson Clinic | Germantown | Tennessee | 38138 | — |
| Urology Associates | Nashville | Tennessee | 37209 | — |
| Texas Oncology P A | Austin | Texas | 78731 | — |
| Parkland Health and Hospital System | Dallas | Texas | 75235 | — |
| Texas Oncology P A 3 | Dallas | Texas | 75246 | — |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | — |
| Texas Oncology P A 2 | Houston | Texas | 77024 | — |
| Houston Metro Urology | Houston | Texas | 77027 | — |
| Texas Oncology San Antonio Northeast | San Antonio | Texas | 78217 | — |
| Texas Oncology P A 1 | Wichita Falls | Texas | 76310 | — |
| University of Utah Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | — |
| Virginia Oncology Associates | Norfolk | Virginia | 23502 | — |
| Oncology and Hematology Associates of Southwest Virginia, Inc. | Roanoke | Virginia | 98684 | — |
| Urology Of Virginia, Pllc | Virginia Beach | Virginia | 23462 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 47 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05884398, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 25, 2026 · Synced Oct 19, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05884398 live on ClinicalTrials.gov.