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Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging
NCT04423211 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04423211
The ClinicalTrials.gov registry entry for NCT04423211 describes a study currently listed as 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 804 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ECOG-ACRIN Cancer Research Group, which has 52 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. 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: NCT04423211 reports 20 study locations spanning 4 distinct geographic areas — top geographies include California, Alaska, 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04423211?
This trial is sponsored by ECOG-ACRIN Cancer Research Group, which has 52 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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