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Adaptive Androgen Deprivation and Docetaxel in Metastatic Castration Sensitive Prostate Cancer

NCT06734130 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-04-01

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Jingsong Zhang, MD, PhD · Moffitt Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-10
Primary Completion
2029-01-31
Completion
2029-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06734130 on ClinicalTrials.gov