Androgen Deprivation Therapy Combined With Docetaxel for High Risk Prostate Cancer

NCT ID: NCT04869371

Last Updated: 2022-12-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-12
• Study Completion Date: 2023-01-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Androgen Deprivation Therapy with Docetaxel

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.

Group Type: EXPERIMENTAL

Docetaxel injection

Intervention Type: DRUG

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

Triptorelin Pamoate for Injectable Suspension

Intervention Type: DRUG

15mg every 12 weeks

Prednisone Acetate Tablets

Intervention Type: DRUG

5 mg oral low dose prednisone, once daily

ADT alone

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.

Group Type: ACTIVE_COMPARATOR

Triptorelin Pamoate for Injectable Suspension

Intervention Type: DRUG

15mg every 12 weeks

Interventions

Docetaxel injection

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

Intervention Type: DRUG

Triptorelin Pamoate for Injectable Suspension

15mg every 12 weeks

Intervention Type: DRUG

Prednisone Acetate Tablets

5 mg oral low dose prednisone, once daily

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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:

1. multi-parameter MRI or PSMA PET / CT shows clinical staging of primary tumor ≥ T3,

2. Gleason score of primary tumor ≥ 8, 3.prostate specific antigen (PSA) ≥20 ng/ml.

3. Eastern Cooperative Oncology Group (ECOG) physical condition score ≤ 1.

4. 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.

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.

6. 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Hongqian Guo

OTHER

Sponsor Role: lead

Responsible Party

Hongqian Guo

chief physician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Hongqian Guo, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 37435500 (View on PubMed)

Other Identifiers

IUNU-PC-106

Identifier Type: -

Identifier Source: org_study_id