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NCT04134260 · ClinicalTrials.gov registry record · Phase 3
Testing the Addition of the Drug Apalutamide to the Usual Hormone Therapy and Radiation Therapy After Surgery for Prostate Cancer, INNOVATE Trial
A Phase 3 study of Prostate Adenocarcinoma and Stage III Prostate Cancer AJCC v8, sponsored by NRG Oncology.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 586
- Enrollment target
- 20
- Study locations
NCT04134260: Recruiting Phase 3 study of Prostate Adenocarcinoma and Stage III Prostate Cancer AJCC v8, sponsored by NRG Oncology.
NCT04134260 is a Phase 3 study of Prostate Adenocarcinoma and Stage III Prostate Cancer AJCC v8 that is actively recruiting participants, run by NRG Oncology. The registered enrollment target is 586 participants, above the 213-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (175% higher). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04134260, a Phase 3 study of Prostate Adenocarcinoma and Stage III Prostate Cancer AJCC v8, is actively recruiting participants, sponsored by NRG Oncology.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 586 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase III trial studies whether adding apalutamide to the usual treatment improves outcome in patients with lymph node positive prostate cancer after surgery. Radiation therapy uses high energy x-ray to kill tumor cells and shrink tumors. Androgens, or male sex hormones, can cause the growth of prostate cancer cells. Drugs, such as apalutamide, may help stop or reduce the growth of prostate cancer cell growth by blocking the attachment of androgen to its receptors on cancer cells, a mechanism similar to stopping the entrance of a key into its lock. Adding apalutamide to the usual hormone therapy and radiation therapy after surgery may stabilize prostate cancer and prevent it from spreading and extend time without disease spreading compared to the usual approach.
Primary Outcome
Kaplan-Meier curves will be generated and metastasis-free survival compared between the two treatment groups by a logrank test, stratified by prostate specific antigen (PSA) level after prostatectomy (never detectable or rising). Cox regression modeling to assess and adjust for the effects of PSA stratum and other baseline covariates will also be performed. The proportional hazards assumption will be tested using Schoenfeld residuals and graphical methods. Martingale residual plots will be exami
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Bone Scan
- DRUG Apalutamide
- DRUG Hormone Therapy
Study Locations (20)
California
- Kaiser Permanente-Anaheim - Anaheim
- Kaiser Permanente-Baldwin Park - Baldwin Park
- Kaiser Permanente-Bellflower - Bellflower
- Mercy Cancer Center - Carmichael - Carmichael
- Mercy San Juan Medical Center - Carmichael
- Mercy Cancer Center - Elk Grove - Elk Grove
- Kaiser Permanente-Fontana - Fontana
- Marin General Hospital - Greenbrae
- Kaiser Permanente South Bay - Harbor City
- Kaiser Permanente-Irvine - Irvine
- Tibor Rubin VA Medical Center - Long Beach
- Kaiser Permanente Los Angeles Medical Center - Los Angeles
- Los Angeles General Medical Center - Los Angeles
- USC / Norris Comprehensive Cancer Center - Los Angeles
- Kaiser Permanente West Los Angeles - Los Angeles
- UCLA / Jonsson Comprehensive Cancer Center - Los Angeles
- Kaiser Permanente-Ontario - Ontario
- Kaiser Permanente - Panorama City - Panorama City
Arizona
- Cancer Center at Saint Joseph's - Phoenix
Arkansas
- University of Arkansas for Medical Sciences - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 586 participants |
| Start Date | 2020-04-16 |
| Est. Completion | 2026-11-01 |
| Phase | Phase 3 |
What NCT04134260 shows while recruiting
NCT04134260 is an interventional study that assigns participants to a tested intervention. The registered 586 participants enrollment target is mid-sized for trials with a published cap, above the 213-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (175% higher).
The record links to 5 conditions, with Prostate Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT04134260 names 20 study sites across 3 states, led by California, Arizona, Arkansas.
Frequently Asked Questions
What is clinical trial NCT04134260 about?
NCT04134260 is a clinical study titled "Testing the Addition of the Drug Apalutamide to the Usual Hormone Therapy and Radiation Therapy After Surgery for Prostate Cancer, INNOVATE Trial". This phase III trial studies whether adding apalutamide to the usual treatment improves outcome in patients with lymph node positive prostate cancer after surgery. Radiation therapy uses high energy x-ray to kill tumor cells and shrink tumors. Androgens, or male sex hormones, can cause the growth of...
What is the current status of trial NCT04134260?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 586 participants. The study started on 2020-04-16. Estimated completion is 2026-11-01.
What conditions does trial NCT04134260 study?
This clinical trial studies the following conditions: Prostate Adenocarcinoma, Stage III Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage I Prostate Cancer AJCC v8.
What interventions are being tested in trial NCT04134260?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Bone Scan (PROCEDURE), Apalutamide (DRUG), Hormone Therapy (DRUG).
Who is sponsoring clinical trial NCT04134260?
This trial is sponsored by NRG Oncology, which has 64 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04134260 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT04134260's enrollment target sits among peer trials
586 9th of 99 higher than 91 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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