Adaptive Androgen Deprivation and Docetaxel in Metastatic Castration Sensitive Prostate Cancer

  • Recruiting
  • Treatment
  • Interventional
  • Drug
  • PHASE2
  • H. Lee Moffitt Cancer Center and Research Institute
  • 18 Years -


Study Purpose

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.

Intervention

Drug : Luteinizing Hormone-Releasing Hormone (LHRH) analog

Drug : Androgen Receptor Signal Inhibitor (ARSI)

Drug : Docetaxel


Eligibility Requirements

info icon Biopsy proven prostate cancer and the diagnosis can be established through either prostate biopsy or biopsy of a metastatic lesion.

info icon 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.

info icon Achieved \>50% PSA decline and \<4 ng/ml PSA after the run-in period.

info icon 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.

info icon 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.

info icon ECOG performance status 0-1.

info icon 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.

info icon 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.

info icon Minimum age: 18

info icon Prior treatments with TAK-700/Orteronel, abiraterone, apalutamide or enzalutamide.

info icon Surgical castration.

info icon Documented liver or brain metastases

info icon 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)

info icon Treatment with any investigational compound within 30 days prior to the first dose of study drugs.

info icon 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.

info icon 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.

info icon Subjects with delayed healing of wounds, ulcers, and/or bone fractures.

Recruiting status

Recruiting

Estimated enrollment

25

 
Study start date

Jan 10, 2025

Study end date

Jan 31, 2027

Last updated

Mar 23, 2025

Primary purpose

Treatment

Design

Interventional

Intervention

Drug

Study phase

PHASE2

Allocation

Na

 

Sponsor:

H. Lee Moffitt Cancer Center and Research Institute

Collaborator:

N/A

Investigator:

Jingsong Zhang, MD, PhD

NCT06734130

Clinic Location Investigator Distance RECRUITING STATUS Contact