Adaptive Androgen Deprivation and Docetaxel in Metastatic Castration Sensitive Prostate Cancer

NCT ID: NCT06734130

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-10
• Study Completion Date: 2028-11-30

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Adaptive Androgen Deprivation and Docetaxel Treatment

This study will consist of various visits: a screening visit, 1-3 visits during the screening standard of care treatment period and visits every 4 weeks during the adaptive therapy period.

Group Type: EXPERIMENTAL

Luteinizing Hormone-Releasing Hormone (LHRH) analog

Intervention Type: DRUG

The choice of the standard of care LHRH analog will be at the discretion of the treating physician.

Androgen Receptor Signal Inhibitor (ARSI)

Intervention Type: DRUG

The choice of the standard of care ARSI will be at the discretion of the treating physician.

Docetaxel

Intervention Type: DRUG

Docetaxel will be given by IV infusion at 75mg/m2 once every 3 weeks.

Interventions

Luteinizing Hormone-Releasing Hormone (LHRH) analog

The choice of the standard of care LHRH analog will be at the discretion of the treating physician.

Intervention Type: DRUG

Androgen Receptor Signal Inhibitor (ARSI)

The choice of the standard of care ARSI will be at the discretion of the treating physician.

Intervention Type: DRUG

Docetaxel

Docetaxel will be given by IV infusion at 75mg/m2 once every 3 weeks.

Intervention Type: DRUG

Other Intervention Names

Degarelix; Leuprolide; Triptorelin; Relugolix; Enzalutamide; Apalutamide; Darolutamide

Eligibility Criteria

Inclusion Criteria

• Biopsy proven prostate cancer and the diagnosis can be established through either prostate biopsy or biopsy of a metastatic lesion.
• No androgen deprivation therapy (ADT) with LHRH analog for more than 4 weeks after the diagnosis of metastatic prostate cancer. Prior ADT in the non-metastatic setting is allowed if it was given > 2 years prior to the diagnosis of metastatic prostate cancer.
• Achieved >50% PSA decline and <4 ng/ml PSA after the run-in period.
• Adequate organ function with absolute neutrophil count > 1000/l, Hb > 10 g/dl, Platelet > 100,000/l, Creatinine and liver enzymes within 1.5 folds of upper limits of normal.
• No uncontrolled arrhythmia; patients with h/o myocardia infarction or history of congestive heart failure, need to have estimated left ventricle ejection fraction above 40% either on echocardiogram or MUGA scan within 6 months of study enrollment.
• ECOG performance status 0-1.
• Non-sterilized men who are sexually active with a female partner of childbearing potential treated or enrolled on this protocol must agree to use adequate contraception prior to the study, for the duration of study participation, and for 6 weeks after last dose of ARSI or docetaxel administration.
• Ability to understand and the willingness to sign a written informed consent document or have a legally authorized representative sign on the subject's behalf. Stated willingness to comply with all study procedures and availability for the duration of the study.

Exclusion Criteria

• Prior treatments with TAK-700/Orteronel, abiraterone, apalutamide or enzalutamide.
• Surgical castration.
• Documented liver or brain metastases
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to docetaxel (including any drugs formulated with polysorbate 80), or LHRH analog (e.g., leuprolide, triptorelin, relugolix, degarelix)
• Treatment with any investigational compound within 30 days prior to the first dose of study drugs.
• Diagnosis or treatment for another systemic malignancy within 2 years before the first dose of LHRH analog, or previously diagnosed with another malignancy & have any evidence of residual disease. Patients with early-stage skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
• Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Subjects with delayed healing of wounds, ulcers, and/or bone fractures.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jingsong Zhang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Locations

Moffitt Caner Center

Tampa, Florida, United States

Countries

United States

Other Identifiers

MCC-23260

Identifier Type: -

Identifier Source: org_study_id