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NCT04423211 · ClinicalTrials.gov registry record · Phase 3
Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging
A Phase 3 study of Prostate Adenocarcinoma and Stage IVB Prostate Cancer AJCC v8, sponsored by ECOG-ACRIN Cancer Research Group.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 804
- Enrollment target
- 20
- Study locations
NCT04423211: Recruiting Phase 3 study of Prostate Adenocarcinoma and Stage IVB Prostate Cancer AJCC v8, sponsored by ECOG-ACRIN Cancer Research Group.
NCT04423211 is a Phase 3 study of Prostate Adenocarcinoma and Stage IVB Prostate Cancer AJCC v8 that is actively recruiting participants, run by ECOG-ACRIN Cancer Research Group. The registered enrollment target is 804 participants, above the 210-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (283% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04423211, a Phase 3 study of Prostate Adenocarcinoma and Stage IVB Prostate Cancer AJCC v8, is actively recruiting participants, sponsored by ECOG-ACRIN Cancer Research Group.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 804 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase III trial tests two questions by two separate comparisons of therapies. The first question is whether enhanced therapy (apalutamide in combination with abiraterone + prednisone) added to standard of care (prostate radiation therapy and short term androgen deprivation) is more effective compared to standard of care alone in patients with prostate cancer who experience biochemical recurrence (a rise in the blood level of prostate specific antigen \[PSA\] after surgical removal of the prostate cancer). A second question tests treatment in patients with biochemical recurrence who show prostate cancer spreading outside the pelvis (metastasis) by positron emission tomography (PET) imaging. In these patients, the benefit of adding metastasis-directed radiation to enhanced therapy (apalutamide in combination with abiraterone + prednisone) is tested. Diagnostic procedures, such as PET, may help doctors look for cancer that has spread to the pelvis. Androgens are hormones that may cause the growth of prostate cancer cells. Apalutamide may help fight prostate cancer by blocking the use of androgens by the tumor cells. Metastasis-directed targeted radiation therapy uses high energy rays to kill tumor cells and shrink tumors that have spread. This trial may help doctors determine if using PET results to deliver more tailored treatment (i.e., adding apalutamide, with or without targeted radiation therapy, to standard of care treatment) works better than standard of care treatment alone in patients with biochemical recurrence of prostate cancer.
Primary Outcome
The power of the PFS analysis is 85% using one-sided 0.025 level stratified logrank test. The overall type I error will be controlled using an O'Brien-Fleming boundary function
Conditions Studied
Interventions
- PROCEDURE Computed Tomography
- RADIATION External Beam Radiation Therapy
- DRUG Apalutamide
- DRUG Degarelix
- RADIATION 3-Dimensional Conformal Radiation Therapy
Study Locations (20)
California
- Mission Hope Medical Oncology - Arroyo Grande - Arroyo Grande
- Providence Saint Joseph Medical Center/Disney Family Cancer Center - Burbank
- Mercy Cancer Center - Carmichael - Carmichael
- Mercy San Juan Medical Center - Carmichael
- City of Hope Corona - Corona
- City of Hope Comprehensive Cancer Center - Duarte
- Mercy Cancer Center - Elk Grove - Elk Grove
- UC San Diego Moores Cancer Center - La Jolla
- City of Hope Antelope Valley - Lancaster
- Los Angeles General Medical Center - Los Angeles
- USC / Norris Comprehensive Cancer Center - Los Angeles
Alaska
- Anchorage Associates in Radiation Medicine - Anchorage
- Alaska Breast Care and Surgery LLC - Anchorage
- Alaska Oncology and Hematology LLC - Anchorage
- Alaska Women's Cancer Care - Anchorage
- Anchorage Oncology Centre - Anchorage
- Katmai Oncology Group - Anchorage
- Providence Alaska Medical Center - Anchorage
Arizona
- Cancer Center at Saint Joseph's - Phoenix
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 804 participants |
| Start Date | 2020-10-08 |
| Est. Completion | 2032-12-31 |
| Phase | Phase 3 |
What NCT04423211 shows while recruiting
NCT04423211 is an interventional study that assigns participants to a tested intervention. The registered 804 participants enrollment target is mid-sized for trials with a published cap, above the 210-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (283% higher).
The record links to 4 conditions, with Prostate Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Computed Tomography is the first listed.
NCT04423211 names 20 study sites across 4 states, led by California, Alaska, Arizona.
Frequently Asked Questions
What is clinical trial NCT04423211 about?
NCT04423211 is a clinical study titled "Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging". This phase III trial tests two questions by two separate comparisons of therapies. The first question is whether enhanced therapy (apalutamide in combination with abiraterone + prednisone) added to standard of care (prostate radiation therapy and short term androgen deprivation) is more effective co...
What is the current status of trial NCT04423211?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 804 participants. The study started on 2020-10-08. Estimated completion is 2032-12-31.
What conditions does trial NCT04423211 study?
This clinical trial studies the following conditions: Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8, Metastatic Prostate Carcinoma, Biochemically Recurrent Prostate Carcinoma.
What interventions are being tested in trial NCT04423211?
The interventions under investigation include: Computed Tomography (PROCEDURE), External Beam Radiation Therapy (RADIATION), Apalutamide (DRUG), Degarelix (DRUG), 3-Dimensional Conformal Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT04423211?
This trial is sponsored by ECOG-ACRIN Cancer Research Group, which has 75 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04423211 being conducted?
This trial has 20 study locations across Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prostate Adenocarcinoma
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 NCT04423211's enrollment target sits among peer trials
804 8th of 99 higher than 92 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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