Adaptive Androgen Deprivation and Docetaxel in Metastatic Castration Sensitive Prostate Cancer

NCT06734130 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: MCC-23260
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Keywords

Prostate cancer

Outcome Measures

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.

  Up to 36 months

Secondary Outcomes (4)

• On treatment PSA Progression Free Survival

  Up to 36 months

• Radiographic Progression Free Survival

  Up to 36 months

• Overall Survival

  Up to 36 months

• Patient Reported Outcome

  Up to 36 months

Study Arms (1)

Adaptive Androgen Deprivation and Docetaxel Treatment

EXPERIMENTAL

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

Androgen Receptor Signal Inhibitor (ARSI) DRUG

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

Also known as: Enzalutamide, Apalutamide, Darolutamide

Adaptive Androgen Deprivation and Docetaxel Treatment

Docetaxel DRUG

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

Adaptive Androgen Deprivation and Docetaxel Treatment

Luteinizing Hormone-Releasing Hormone (LHRH) analog DRUG

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

Adaptive Androgen Deprivation and Docetaxel Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead

Study Sites (1)

Moffitt Caner Center

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Gonadotropin-Releasing Hormone; acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide; Leuprolide; Triptorelin Pamoate; relugolix; enzalutamide; apalutamide; darolutamide; Docetaxel

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Jingsong Zhang, MD, PhD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 16, 2024
• Study Start: January 10, 2025
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

US (1)