Neoadjuvant Chemo-hormonal Therapy Combined With Radical Prostatectomy for Locally Advanced Prostate Cancer

January 4, 2020 updated by: RenJi Hospital

A Prospective, Multicenter, Three-arm, Randomized, Controlled Study Comparing the Efficacy of Neoadjuvant Hormonal Therapy Combined With Systemic Chemotherapy (NCHT), Neoadjuvant Hormonal Therapy (NHT) and Radical Prostatectomy Only in Locally Advanced Prostate Cancer

To evaluate of the value of radical prostatectomy and extended pelvic lymph node dissection in locally advanced prostate cancer after neoadjuvant hormonal therapy with or without docetaxel chemotherapy.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Using larger sample prospective randomized controlled study design, and comparing neoadjuvant HT combined with docetaxel chemotherapy to neoadjuvant HT followed by RP and extended lymph node dissection to determine whether neoadjuvant HT combined with docetaxel chemotherapy can more effectively improve biochemical progression-free survival of locally advanced prostate cancer patients.

Further analysis was performed to determine whether the treatment regimen helped to prolong the radiologic progression-free survival (rPFS) or OS in these patients.

The pathological changes of tumor before and after neoadjuvant treatment were also analyzed. To search for the important risk factors influencing the long-term prognosis of these patients, the safety characteristics of patients in different treatment groups were analyzed. Therefore, it can provide the basis for the formulation of the optimal treatment plan for locally advanced prostate cancer, prolong the survival time of patients and improve the quality of life.

Study design: Prospective，Multicenter, Open-label, Parallel group, Randomized (2:2:1) Controlled , Clinical Trial

Study group: Newly diagnosed, untreated cT3a-cT4 or any cT, cN1 in locally advanced hormone-sensitive prostate cancer.

Study group number: 475 cases, Randomized 2:2:1

Study Type

Interventional

Enrollment (Anticipated)

475

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. 18≤ Aged <75 years, male;
  2. Histology or cytology diagnosis: Prostate adenocarcinoma;
  3. ECOG performance Status ≤1; Expected lifetime ≥10 years;
  4. Without clinical or radiographic metastases in 6 months (Bone scan, MRI or pelvic enhanced CT scan, PET-CT) before randomized;
  5. The patients of locally advanced prostate cancer need to satisfy at least one of the following requirements: clinical stageT3a-T4, N0, M0; any T, N1, M0;
  6. Without Androgen Blockade Treatment in 4 weeks before randomized;
  7. Without radiographic treatment towards primary tumour;
  8. Without opioids (including codeine and dextropropoxyphene) relieving relevant pain of cancer;
  9. Without azole drugs (such as fluconazole, itraconazole);

  10. Important laboratory indicators are as follows:

    1. Haemoglobin ≥90g/L
    2. ANC ≥ 1500/μL
    3. PLT≥100*10^9/L
    4. K+≥3.5mmol/L
    5. AST or ALT ≤1.5 times upper limit of normal (ULN), TBIL should be ≤ULN (except patients with certified Gilbert syndrome) and ALP≤5ULN
    6. ALB≥30g / L
    7. calculated Ccr>60 ml/min, serum creatinine ≤ ULN
  11. Without swallowing disease, able to swallow the whole piece of drugs;
  12. Without other tumour chemotherapy history, without chemotherapy and endocrine therapy contraindications;
  13. If patient's spouse is at her childbearing age, the patient needs to agree that effective contraception should be taken during the treatment and 4 months after the operation.
  14. Subjects volunteer to participate, the subject must sign an informed consent form (ICF), indicating the understanding of the purpose and the required procedures of the study, and willing to participate in the study. Subjects must be willing to comply with the prohibitions and restrictions set forth in the program.

Exclusion Criteria:

  1. The pathology result of prostate is neuroendocrine prostate cancer, including small cell carcinoma;
  2. Previous cytotoxic chemotherapy or biological therapy for prostate cancer;
  3. Contraindications to prednisone, such as active infections or other disorders;
  4. Patients with chronic disease needed to be given dose of prednisone (each time 5mg, bid a day) exceed the dose in the study;
  5. High blood pressure with poor control of drugs (systolic blood pressure ≥160mmHg or diastolic blood pressure ≥95mmHg);
  6. Active or symptomatic viral hepatitis or other chronic liver disease, known infected with human immunodeficiency virus (HIV);
  7. A disease history of pituitary or adrenal dysfunction;
  8. Patients with active autoimmune disease who need hormone therapy;
  9. Heart disease with clinical significance, including: myocardial infarction or arterial thrombosis occurred in the past 6 months; severe or unstable angina; New York Heart Association grade III or IV heart disease (Appendix 4); atrial fibrillation or other arrhythmias that require treatment;
  10. Subjects who participated in other clinical studies within a month before the first use of chemotherapy; (the elution time is at least 5 times the half-life time of the study drug if the half-life time is too long.)
  11. Patients with a history of hypersensitivity to Taxanes or docetaxel
  12. Patients who are concomitantly receiving strong CYP3A4 inhibitors
  13. Other circumstances considered inappropriate by investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NCHT Group
Neoadjuvant chemotherapy combined with hormone therapy, Radical Prostatectomy (RP)+ extended lymph node dissection
Drug: Neoadjuvant chemotherapy combined with hormone therapy
Docetaxel 75mg/m2 IV (every 3 weeks) +Prednisone 5mg BID orally + HT (Bicalutamide Tablets, 50mg QD orally; Goserelin, 3.6mg, subcutaneous injection, q28d), 4-6 cycles
Other Names:
  • NCHT
Procedure: Radical Prostatectomy (RP)+ extended lymph node dissection

Radical Prostatectomy (RP)+ extended lymph node dissection: Within three months after neoadjuvant treatment.

Treatment after prostatectomy: There will not have any drug treatment after surgery until disease progression.

Pelvic lymph node dissection is required to reach the level of bilateral iliac artery. If the postoperative pathology indicated positive incisional margin or pelvic lymph node metastasis, pelvic adjuvant radiotherapy should be performed within 3 months after surgery.

Other Names:
  • RP+ePLND
Active Comparator: NHT Group
Neoadjuvant hormonal therapy, radical Prostatectomy (RP)+ extended lymph node dissection.
Procedure: Radical Prostatectomy (RP)+ extended lymph node dissection

Radical Prostatectomy (RP)+ extended lymph node dissection: Within three months after neoadjuvant treatment.

Treatment after prostatectomy: There will not have any drug treatment after surgery until disease progression.

Pelvic lymph node dissection is required to reach the level of bilateral iliac artery. If the postoperative pathology indicated positive incisional margin or pelvic lymph node metastasis, pelvic adjuvant radiotherapy should be performed within 3 months after surgery.

Other Names:
  • RP+ePLND
Drug: Neoadjuvant hormone therapy
HT (Bicalutamide Tablets, 50mg QD orally; Goserelin, 3.6mg, subcutaneous injection, q28d), 3-6 cycles
Other Names:
  • NHT
Other: RP Group
Radical Prostatectomy (RP)+ extended lymph node dissection alone.
Procedure: Radical Prostatectomy (RP)+ extended lymph node dissection

Radical Prostatectomy (RP)+ extended lymph node dissection: Within three months after neoadjuvant treatment.

Treatment after prostatectomy: There will not have any drug treatment after surgery until disease progression.

Pelvic lymph node dissection is required to reach the level of bilateral iliac artery. If the postoperative pathology indicated positive incisional margin or pelvic lymph node metastasis, pelvic adjuvant radiotherapy should be performed within 3 months after surgery.

Other Names:
  • RP+ePLND

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bPFS (Biochemical progression-free survival)
Time Frame: about 2 years
Biochemical recurrence-free survival (bPFS): defined as the time from randomization to biochemical recurrence. The definition of biochemical recurrence is as follows: in the case of normal testosterone levels, the PSA was >0.2 ng/ml twice for more than 4 consecutive weeks.
about 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The 1-year biochemical progression-free survival (bPFS) rate
Time Frame: 1 year
The ratio of patients whose consecutive postoperative PSA <0.2ng/ml within 1-year.
1 year
Overall survival (OS)
Time Frame: 5-10 years
The time from randomization to death due to all causes.
5-10 years
Radiographic progression-free survival (rPFS)
Time Frame: 3-5 years
The time from randomization to first confirmed imaging progression or death (whichever first is counted). Imaging progression was defined as one of the following: a. Progression of soft tissue lesions as defined in the revised RECIST 1.1 (Appendix 8) found by CT or MRI. b. Confirmation of bone metastasis lesions by ECT or PET-CT examination.
3-5 years
TTPP
Time Frame: 1-3 years
The time from randomization to the time when PSA increased by 25%.
1-3 years
ECOG score progression-free survival
Time Frame: 3-5 years
The time from treatment to the time of ECOG score progression.
3-5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 10, 2020

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

January 2, 2020

First Submitted That Met QC Criteria

January 4, 2020

First Posted (Actual)

January 7, 2020

Study Record Updates

Last Update Posted (Actual)

January 7, 2020

Last Update Submitted That Met QC Criteria

January 4, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCANT-20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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