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Active, not recruitingNCT06734130Updated Apr 1, 2026

Adaptive Androgen Deprivation and Docetaxel in Metastatic Castration Sensitive Prostate Cancer

A Phase 2 interventional study of Luteinizing Hormone-Releasing Hormone (LHRH) analog and Androgen Receptor Signal Inhibitor (ARSI) in Metastatic Castration Sensitive Prostate Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute. Active, not recruiting at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-01.

Sponsored by H. Lee Moffitt Cancer Center and Research Institute · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years and older
Sex
Male
01

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.

02

Conditions studied

  • Metastatic Castration Sensitive Prostate Cancer

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Keywords

  • Prostate cancer
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 25 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute is the lead sponsor of 533 studies on the registry; 74 are open to participants now.

Of its 99 completed or terminated interventional studies of FDA-regulated products, 57 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    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.

    Drug: Luteinizing Hormone-Releasing Hormone (LHRH) analog · Drug: Androgen Receptor Signal Inhibitor (ARSI) · Drug: Docetaxel

Interventions

  • DrugLuteinizing Hormone-Releasing Hormone (LHRH) analog

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

    Also known as: Degarelix, Leuprolide, Triptorelin, Relugolix

  • DrugAndrogen Receptor Signal Inhibitor (ARSI)

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

    Also known as: Enzalutamide, Apalutamide, Darolutamide

  • DrugDocetaxel

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

06

What researchers measure

Primary outcomes

  1. Castration Sensitivity Rate

    Percentage of patients who remain castration sensitive at 36 months from initiation of LHRH analog for stage IV prostate cancer.

    Time frame: Up to 36 months

Secondary outcomes

  1. On treatment PSA Progression Free Survival

    On treatment PSA progression free survival will be analyzed using the Kaplan-Meier method.

    Time frame: Up to 36 months

  2. Radiographic Progression Free Survival

    Radiographic progression free survival will be analyzed using the Kaplan-Meier method.

    Time frame: Up to 36 months

  3. Overall Survival

    Overall survival will be analyzed using the Kaplan-Meier method.

    Time frame: Up to 36 months

  4. Patient Reported Outcome

    Patient reported outcome as measured by National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Prostate Cancer Symptom Index -17 items (NFPSI-17).

    Time frame: Up to 36 months

07

Study locations

1 site
  • Moffitt Caner Center
    Tampa, Florida 33612, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06734130
Lead sponsor
H. Lee Moffitt Cancer Center and Research Institute
Responsible party
Sponsor
First posted
Dec 16, 2024
Start date
Jan 10, 2025
Primary completion
Jan 2029 (estimated)
Completion
Jan 2029 (estimated)
Last update
Apr 1, 2026

Study contacts

Jingsong Zhang, MD, PhD
principal investigator · Moffitt Cancer Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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