Androgen Deprivation Therapy Combined With Docetaxel for High Risk Prostate Cancer

NCT04869371 | Unknown Phase 2 FDA Drug

• 1 other identifier: IUNU-PC-106
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized, controlled, single center clinical trial aims to evaluate the efficacy and safety of Androgen Deprivation Therapy Combined with Docetaxel for High Risk Prostate Cancer with a six-month treatment cycle.

Conditions

Neoadjuvant Therapy \ High Risk Prostate Cancer \ Docetaxel

Outcome Measures

Primary Outcomes (2)

• Pathologic Complete Response Rate

  The proportion of subjects with no morphologically recognizable cancer cell in tumor specimens after radical prostatectomy.

  up to 8 months

• pCR or MRD rate

  The proportion of patients with pCR or MRD. Pathologic complete response (pCR): defined as no morphologically recognizable cancer cell in tumor specimens after radical prostatectomy. Minimal Residual Disease (MRD): defined as residual tumors with maximum diameter of 3 mm or less after radical prostatectomy.

  up to 8 months

Secondary Outcomes (15)

• Imaging Response Rate

  up to 8 months

• Rate of Stage Degradation

  up to 8 months

• Rate of Positive Surgical Margins

  up to 8 months

• Rate of Complete Serum Remission

  up to 8 months

• Operative time (min)

  12 month

Study Arms (2)

Androgen Deprivation Therapy with Docetaxel

EXPERIMENTAL

All subjects in this arm will receive luteinizing hormone releasing hormone analogue (LHRHa) plus docetaxel and prednisone, as per standard of care. Triptorelin pamoate (Diphereline) 15mg will be used once per 12 weeks. Docetaxel (75 mg/m2 body surface area) will be administered as intravenous drip every 3 weeks for 6 cycles. Robot assisted radical prostatectomy will be followed in 2 weeks when 24-week treatment cycle is finished.

Drug: Docetaxel injection; Drug: Triptorelin Pamoate for Injectable Suspension; Drug: Prednisone Acetate Tablets

ADT alone

ACTIVE COMPARATOR

All subjects in this arm will receive LHRHa alone for 24 weeks before receiving robot assisted radical prostatectomy. Triptorelin Pamoate 15mg will be administered once per 12 weeks.

Drug: Triptorelin Pamoate for Injectable Suspension

Interventions

Docetaxel injection DRUG

75 mg/m2 body surface area every 3 weeks for 6 cycles before robot assisted radical prostatectomy

Androgen Deprivation Therapy with Docetaxel

Triptorelin Pamoate for Injectable Suspension DRUG

15mg every 12 weeks

ADT alone; Androgen Deprivation Therapy with Docetaxel

Prednisone Acetate Tablets DRUG

5 mg oral low dose prednisone, once daily

Androgen Deprivation Therapy with Docetaxel

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be ≥ 18 and ≤75 years of age.
• All patients must have a histologically or cytologically diagnosis of prostate cancer and must be eligible for radical prostatectomy.
• All patients must undergo thorough tumor staging and meet one of the following criteria:
• multi-parameter MRI or PSMA PET / CT shows clinical staging of primary tumor ≥ T3,
• Gleason score of primary tumor ≥ 8, 3.prostate specific antigen (PSA) ≥20 ng/ml.
• Eastern Cooperative Oncology Group (ECOG) physical condition score ≤ 1.
• Patients must have adequate hematologic function, within 28 days prior to registration as evidenced by: white blood cell (WBC) ≥ 4.0 × 109 /L, platelets≥ 100 × 109 / L, hemoglobin ≥ 9 g / dL, and international normalized ratio (INR) \< 1.5.
• Patients must have adequate hepatic function, within 28 days prior to registration, as evidenced by: total bilirubin (TBIL)≤1.5 x upper limit of normal (ULN),and SGOT (AST) and SGPT (ALT) ≤ 2.5 x ULN.
• Patients must have adequate renal function, within 28 days prior toregistration, as evidenced by serum creatinine ≤2×ULN
• Patients must participate voluntarily and sign an informed consent form(ICF), indicating that they understand the purpose and required procedures of the study, and are willing to participate in. Patients must be willing to obey the prohibitions and restrictions specified in the research protocol.

You may not qualify if:

• Patients with prostate having neuroendocrine, small cell, or sarcoma-like features are not eligible.
• Patients with low-risk and medium-risk, localized prostate cancer (the following conditions are met at the same time) are not eligible: multiparameter MRI or PSMA PET / CT shows clinical staging of primary tumor \< T3, Gleason score of primary tumor \< 8, and prostate specific antigen (PSA) \<20 ng/ml.
• Patients with clinical or radiological evidence of extra-regional lymph node metastases or bone metastases or visceral metastases are not eligible.
• Patients who have previously received androgen deprivation therapy (medical or surgical) or focal treatment of prostate cancer or prostate cancer radiotherapy or prostate cancer chemotherapy are not eligible.
• Patients with severe or uncontrolled concurrent infections are not eligible.
• Patients must not have New York Heart Association Class III or IV congestive heart failure at the time of screening. Patients must not have any thromboembolic event, unstable angina pectoris, myocardial infarction within 6 months prior to registration.
• Patients must not have uncontrolled severe hypertension, persistent uncontrolled diabetes, oxygen-dependent lung disease, chronic liver disease, or HIV infection.
• Patients must not have had other malignancies other than prostate cancer in the past 5 years, but cured basal cell or squamous cell skin cancers can be enrolled.
• Patients with mental illness, mental disability or inability to give informed consent are not eligible.

Sponsors & Collaborators

• Hongqian Guo: lead

Study Sites (1)

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210000, China

Location

Related Publications (1)

• Zhuang J, Wang Y, Zhang S, Fu Y, Huang H, Lyu X, Zhang S, Marra G, Xu L, Qiu X, Guo H. Androgen deprivation therapy plus abiraterone or docetaxel as neoadjuvant therapy for very-high-risk prostate cancer: a pooled analysis of two phase II trials. Front Pharmacol. 2023 Jun 26;14:1217303. doi: 10.3389/fphar.2023.1217303. eCollection 2023.

  PMID: 37435500 DERIVED

MeSH Terms

Interventions

Docetaxel; Triptorelin Pamoate; Prednisone

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Gonadotropin-Releasing Hormone; 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; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Hongqian Guo, MD

  Nanjing Drum Tower Hospital, affiliated to medical school of Nanjing University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: April 9, 2021
• First Posted: May 3, 2021
• Study Start: December 12, 2018
• Primary Completion: December 1, 2020
• Study Completion: January 1, 2023
• Last Updated: December 29, 2022

Record last verified: 2022-12

Locations

CN (1)