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Testing the Addition of Docetaxel (Chemotherapy) to the Usual Treatment (Hormonal Therapy and Apalutamide) for Metastatic Prostate Cancer, ASPIRE Trial
NCT06931340 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06931340
The ClinicalTrials.gov registry entry for NCT06931340 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 1,260 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alliance for Clinical Trials in Oncology, which has 147 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. 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: NCT06931340 reports 20 study locations spanning 2 distinct geographic areas — top geographies include California, 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06931340?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 147 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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