NCT06734130

Adaptive Androgen Deprivation and Docetaxel in Metastatic Castration Sensitive Prostate Cancer

A Phase IIA Study of Adaptive Androgen Deprivation and Docetaxel in Metastatic Castration Sensitive Prostate Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective single center phase IIa open label nonrandomized study, which aims to test the hypothesis that the duration of castration sensitive phase of stage IV prostate cancer can be prolonged with adaptive androgen deprivation therapy (ADT) and Docetaxel.

Conditions

• Metastatic Castration Sensitive Prostate Cancer

Interventions

Type	Name	Description
DRUG	Luteinizing Hormone-Releasing Hormone (LHRH) analog	The choice of the standard of care LHRH analog will be at the discretion of the treating physician.
DRUG	Androgen Receptor Signal Inhibitor (ARSI)	The choice of the standard of care ARSI will be at the discretion of the treating physician.
DRUG	Docetaxel	Docetaxel will be given by IV infusion at 75mg/m2 once every 3 weeks.

Timeline

• Start date: 2025-01-10
• Primary completion: 2029-01-01
• Completion: 2029-01-01
• First posted: 2024-12-16
• Last updated: 2026-04-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study