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NCT06931340 · ClinicalTrials.gov registry record · Phase 3
Testing the Addition of Docetaxel (Chemotherapy) to the Usual Treatment (Hormonal Therapy and Apalutamide) for Metastatic Prostate Cancer, ASPIRE Trial
A Phase 3 study of Stage IVB Prostate Cancer AJCC v8 and Metastatic Prostate Adenocarcinoma, sponsored by Alliance for Clinical Trials in Oncology.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 1,260
- Enrollment target
- 20
- Study locations
NCT06931340: Recruiting Phase 3 study of Stage IVB Prostate Cancer AJCC v8 and Metastatic Prostate Adenocarcinoma, sponsored by Alliance for Clinical Trials in Oncology.
NCT06931340 is a Phase 3 study of Stage IVB Prostate Cancer AJCC v8 and Metastatic Prostate Adenocarcinoma that is actively recruiting participants, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 1,260 participants, above the 149-participant average among 45 other Stage IVB Prostate Cancer AJCC v8 trials with a reported enrollment target (746% higher). The trial reports 20 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06931340, a Phase 3 study of Stage IVB Prostate Cancer AJCC v8 and Metastatic Prostate Adenocarcinoma, is actively recruiting participants, sponsored by Alliance for Clinical Trials in Oncology.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,260 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase III trial compares the effect of adding docetaxel to hormonal therapy and apalutamide versus hormonal therapy and apalutamide alone in treating patients with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Hormone therapy for prostate cancer, also called androgen deprivation therapy (ADT), uses surgery or drugs to lower the levels of male sex hormones in a man's body. This helps slow the growth of prostate cancer. Apalutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of tumor cells. Giving docetaxel in addition to the usual treatment of hormonal therapy and apalutamide may work better in treating patients with metastatic prostate cancer than the usual treatment alone.
Primary Outcome
Will determine OS. To assess the potential OS benefit from the triplet therapy, a group sequential efficacy/futility monitoring design will be employed. The planned analyses for OS will be tested using a one-sided type 1 error rate of 0.025. An intent-to-treat approach will be used to evaluate OS between treatments. The stratified logrank test will be the primary analysis to compare OS between treatments. The Kaplan-Meier estimate will be used to evaluate the within treatment OS distributions. I
Conditions Studied
Interventions
- PROCEDURE Computed Tomography
- DRUG Docetaxel
- PROCEDURE Magnetic Resonance Imaging
- DRUG Apalutamide
- DRUG Androgen Therapy
Study Locations (20)
California
- Kaiser Permanente Dublin - Dublin
- Kaiser Permanente-Fremont - Fremont
- Kaiser Permanente Fresno Orchard Plaza - Fresno
- UC San Diego Moores Cancer Center - La Jolla
- Kaiser Permanente- Modesto MOB II - Modesto
- Kaiser Permanente-Modesto - Modesto
- Kaiser Permanente-Oakland - Oakland
- Eisenhower Medical Center - Rancho Mirage
- Kaiser Permanente-Roseville - Roseville
- Kaiser Permanente Downtown Commons - Sacramento
- Kaiser Permanente-South Sacramento - Sacramento
- UC San Diego Medical Center - Hillcrest - San Diego
- Kaiser Permanente-San Francisco - San Francisco
- Kaiser Permanente-Santa Teresa-San Jose - San Jose
- Kaiser Permanente San Leandro - San Leandro
- Kaiser San Rafael-Gallinas - San Rafael
- Kaiser Permanente Medical Center - Santa Clara - Santa Clara
- Kaiser Permanente-Santa Rosa - Santa Rosa
Arizona
- Banner University Medical Center - Tucson - Tucson
- University of Arizona Cancer Center-North Campus - Tucson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,260 participants |
| Start Date | 2025-12-01 |
| Est. Completion | 2039-05-08 |
| Phase | Phase 3 |
What NCT06931340 shows while recruiting
NCT06931340 is an interventional study that assigns participants to a tested intervention. Its 1,260 participants enrollment target places it among the larger protocols in the corpus, above the 149-participant average among 45 other Stage IVB Prostate Cancer AJCC v8 trials with a reported enrollment target (746% higher).
The record links to 3 conditions, with Stage IVB Prostate Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Computed Tomography is the first listed.
NCT06931340 names 20 study sites across 2 states, led by California, Arizona.
Frequently Asked Questions
What is clinical trial NCT06931340 about?
NCT06931340 is a clinical study titled "Testing the Addition of Docetaxel (Chemotherapy) to the Usual Treatment (Hormonal Therapy and Apalutamide) for Metastatic Prostate Cancer, ASPIRE Trial". This phase III trial compares the effect of adding docetaxel to hormonal therapy and apalutamide versus hormonal therapy and apalutamide alone in treating patients with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Docetaxel is i...
What is the current status of trial NCT06931340?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,260 participants. The study started on 2025-12-01. Estimated completion is 2039-05-08.
What conditions does trial NCT06931340 study?
This clinical trial studies the following conditions: Stage IVB Prostate Cancer AJCC v8, Metastatic Prostate Adenocarcinoma, Castration-Sensitive Prostate Carcinoma.
What interventions are being tested in trial NCT06931340?
The interventions under investigation include: Computed Tomography (PROCEDURE), Docetaxel (DRUG), Magnetic Resonance Imaging (PROCEDURE), Apalutamide (DRUG), Androgen Therapy (DRUG).
Who is sponsoring clinical trial NCT06931340?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06931340 being conducted?
This trial has 20 study locations across Arizona, 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 NCT06931340's enrollment target sits among peer trials
1,260 2nd of 45 the highest of 45 other Stage IVB Prostate Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage IVB Prostate Cancer AJCC v8 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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