A Study of Apalutamide (Adjuvant Treatment) and Androgen Deprivation Therapy (ADT) in Participants Who Have Undergone Radical Prostatectomy (RP) for Non-metastatic Prostate Cancer and Who Are at High Risk for Metastases
Public ClinicalTrials.gov record NCT04523207. 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 Multi-center, Open-label, Single-arm Phase 2 Study of the Adjuvant Treatment of Apalutamide and Androgen Deprivation Therapy (ADT) in Treatment-naïve Participants Who Have Undergone Radical Prostatectomy (RP) for Non-metastatic Prostate Cancer and Who Are at High Risk for Metastases
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Main Study: The purpose of main study is to assess if the combination of apalutamide and androgen deprivation therapy (ADT) in participants with high-risk localized prostate cancer improves the biochemical recurrence (BCR) free rate. Sub-study: The purpose of the sub-study is to assess if the co administration of apalutamide and relugolix is able to maintain castrate levels of testosterone.
Study identification
- NCT ID
- NCT04523207
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 108 participants
Conditions and interventions
Conditions
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 19, 2020 (Actual)
- Primary completion
- Oct 23, 2023 (Actual)
- Completion
- Oct 25, 2023 (Actual)
- Last update posted
- Apr 21, 2026
2020 – 2023
United States locations
- U.S. sites
- 32
- U.S. states
- 23
- U.S. cities
- 31
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Urology Specialists 1 | Tucson | Arizona | 85704 | — |
| Arizona Urology Specialists | Tucson | Arizona | 85741 | — |
| Arkansas Urology | Little Rock | Arkansas | 72211 | — |
| Skyline Urology | Sherman Oaks | California | 91411 | — |
| Genesis Research | Torrance | California | 90505 | — |
| The Urology Center of Colorado | Denver | Colorado | 80211 | — |
| Foothills Urology - Golden Off | Lakewood | Colorado | 80228 | — |
| Urological Research Network | Hialeah | Florida | 33016 | — |
| Idaho Urologic Institute | Meridian | Idaho | 83642 | — |
| First Urology, PSC | Jeffersonville | Indiana | 47130 | — |
| The Iowa Clinic | West Des Moines | Iowa | 50266 | — |
| Wichita Urology Group | Wichita | Kansas | 67226 | — |
| Ochsner LSU Health Shreveport - Regional Urology | Shreveport | Louisiana | 71106 | — |
| Michigan Institute of Urology, PC | Troy | Michigan | 48084 | — |
| Adult Pediatric Urology & Urogynecology, P.C | Omaha | Nebraska | 68114 | — |
| New Jersey Urology LLC | Voorhees Township | New Jersey | 08043 | — |
| Great Lakes Physician PC d/b/a Western New York Urology Associates | Cheektowaga | New York | 14225 | — |
| Associated Medical Professionals | Syracuse | New York | 13210 | — |
| Associated Urologists of North Carolina | Raleigh | North Carolina | 27612 | — |
| The Urology Group | Cincinnati | Ohio | 45212 | — |
| Oregon Urology Institute | Springfield | Oregon | 97477 | — |
| MidLantic Urology | Bala-Cynwyd | Pennsylvania | 19004 | — |
| Lancaster Urology | Lancaster | Pennsylvania | 17604 | — |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | 29572 | — |
| Lexington Urology | West Columbia | South Carolina | 20169 | — |
| Urology Associates | Nashville | Tennessee | 37209 | — |
| Urology Austin | Austin | Texas | 78745 | — |
| Houston Metro Urology | Houston | Texas | 77027 | — |
| Urology San Antonio Research | San Antonio | Texas | 78229 | — |
| Virginia Urology | Richmond | Virginia | 23235 | — |
| Urology Of Virginia, Pllc | Virginia Beach | Virginia | 23462 | — |
| Spokane Urology | Spokane | Washington | 99202 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04523207, 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 Apr 21, 2026 · Synced Oct 31, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04523207 live on ClinicalTrials.gov.