NCT06060587

Randomized Phase II Study of ADT + Abiraterone vs ADT + Docetaxel + Abiraterone

A Randomized Phase II Study of ADT + Abiraterone Versus ADT + Docetaxel + Abiraterone in Patients With Low Volume Metastatic Hormone Sensitive Prostate Cancer

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Primary Objective: 1\. To assess Progression Free Survival (PFS) for each treatment arms (abiraterone+docetaxel+ADT and abiraterone+ADT) to compare for any difference in efficacy Secondary Objective: 1. To assess Overall Survival (OS) for each treatment arm (abiraterone+docetaxel+ADT and abiraterone+ADT) to compare for any difference in efficacy 2. To assess PSA Response Rate for each treatment arm (abiraterone+docetaxel+ADT and abiraterone+ADT) to compare for any difference in efficacy 3. To assess ORR with measurable disease at baseline for each treatment arm for (abiraterone+docetaxel+ADT and abiraterone+ADT) to compare for any difference in efficacy 4. Assessment of Time to castration resistant prostate cancer for each treatment arm (abiraterone+docetaxel+ADT and abiraterone+ADT) to compare for any difference in efficacy 5. Assess time to initiation of subsequent anti-neoplastic therapy for each treatment arm (abiraterone+docetaxel+ADT and abiraterone+ADT) to compare for any difference in efficacy Exploratory Objectives: 1. Assess Quality of Life (QoL) via the FACT-P QoL assessment tool (Appendix A QoL Survey FACT-P) for each treatment arm (abiraterone+docetaxel+ADT and abiraterone+ADT) to compare for any difference in efficacy 2. Assessment of Rates of Adverse Events (AEs)/Serious adverse events (SAEs) for each treatment arm (abiraterone+docetaxel+ADT and abiraterone+ADT) to compare for any difference in safety

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Docetaxel	75 mg/m2 via IV
DRUG	ADT	Prior to randomization as part of standard of care.
DRUG	Abiraterone	1000 mg by mouth

Timeline

• Start date: 2023-10-19
• Primary completion: 2024-05-03
• Completion: 2030-12-22
• First posted: 2023-09-29
• Last updated: 2025-10-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study