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

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ClinicalTrials.gov Identifier: NCT04220398
Recruitment Status : Not yet recruiting
First Posted : January 7, 2020
Last Update Posted : January 7, 2020
Sponsor:
Information provided by (Responsible Party):
RenJi Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Chemotherapy Effect Hormone Sensitive Prostate Cancer Locally Advanced Prostate Carcinoma Drug: Neoadjuvant chemotherapy combined with hormone therapy Drug: Neoadjuvant hormone therapy Procedure: Radical Prostatectomy (RP)+ extended lymph node dissection Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 475 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized 2:2:1
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : January 10, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


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 Name: 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 Name: RP+ePLND

Active Comparator: NHT Group
Neoadjuvant hormonal therapy, radical Prostatectomy (RP)+ extended lymph node dissection.
Drug: Neoadjuvant hormone therapy
HT (Bicalutamide Tablets, 50mg QD orally; Goserelin, 3.6mg, subcutaneous injection, q28d), 3-6 cycles
Other Name: NHT

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 Name: RP+ePLND

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 Name: RP+ePLND




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Overall survival (OS) [ Time Frame: 5-10 years ]
    The time from randomization to death due to all causes.

  3. 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.

  4. TTPP [ Time Frame: 1-3 years ]
    The time from randomization to the time when PSA increased by 25%.

  5. ECOG score progression-free survival [ Time Frame: 3-5 years ]
    The time from treatment to the time of ECOG score progression.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04220398


Contacts
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Contact: Wei Xue 08613801931604 xuewei@renji.com
Contact: Chenfei Chi 08613661633570 chichenfei@renji.com

Sponsors and Collaborators
RenJi Hospital
  Study Documents (Full-Text)

Documents provided by RenJi Hospital:
Publications:

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Responsible Party: RenJi Hospital
ClinicalTrials.gov Identifier: NCT04220398    
Other Study ID Numbers: PCANT-20
First Posted: January 7, 2020    Key Record Dates
Last Update Posted: January 7, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs