Randomized Phase II Study of ADT + Abiraterone vs ADT + Docetaxel + Abiraterone
Public ClinicalTrials.gov record NCT06060587. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized Phase II Study of ADT + Abiraterone Versus ADT + Docetaxel + Abiraterone in Patients With Low Volume Metastatic Hormone Sensitive Prostate Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a phase II, randomized, open label study comparing first line therapy with AThis is a phase II, randomized, open label study comparing first line therapy with ADT + abiraterone (doublet arm) or ADT + abiraterone + docetaxel (triplet arm) in low volume, metastatic hormone sensitive prostate cancer (mHSPC). This is a phase II, randomized, open label study comparing first line therapy with Androgen Deprivation Therapy (ADT) + abiraterone (doublet arm) or ADT + abiraterone + docetaxel (triplet arm) in low volume, metastatic hormone sensitive prostate cancer (mHSPC). The hypothesis being asked in this trial is whether first line treatment with ADT plus an androgen receptor pathway inhibitor (abiraterone) as a doublet regimen compared to ADT plus an androgen receptor pathway inhibitor (abiraterone) and docetaxel, as a triplet regimen results in superior outcomes for patients with low volume mHSPC. We plan to enroll patients with mHPSC that meet the CHAARTED criteria for low disease volume. Patients will be randomized 1:1 to either treatment arm: * doublet arm: abiraterone +ADT or * triplet arm: abiraterone + ADT + docetaxel. All subjects must receive ADT of the Investigator's choice (LHRH agonist/antagonists or orchiectomy) as standard therapy, started = 12 weeks before randomization.
Study identification
- NCT ID
- NCT06060587
- Recruitment status
- Withdrawn
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- Not listed
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 18, 2023
- Primary completion
- May 2, 2024
- Completion
- Dec 21, 2030
- Last update posted
- Oct 21, 2025
2023 – 2030
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06060587, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 21, 2025 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06060587 live on ClinicalTrials.gov.