NCT04220398

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
475

participants targeted

Target at P75+ for not_applicable prostate-cancer

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable prostate-cancer

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 2, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 7, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

January 10, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

January 7, 2020

Status Verified

January 1, 2020

Enrollment Period

3 years

First QC Date

January 2, 2020

Last Update Submit

January 4, 2020

Conditions

Prostate CancerChemotherapy EffectHormone Sensitive Prostate CancerLocally Advanced Prostate Carcinoma

Outcome Measures

Primary Outcomes (1)

  • bPFS (Biochemical progression-free survival)

    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 Outcomes (5)

  • The 1-year biochemical progression-free survival (bPFS) rate

    1 year

  • Overall survival (OS)

    5-10 years

  • Radiographic progression-free survival (rPFS)

    3-5 years

  • TTPP

    1-3 years

  • ECOG score progression-free survival

    3-5 years

Study Arms (3)

NCHT Group

EXPERIMENTAL

Neoadjuvant chemotherapy combined with hormone therapy, Radical Prostatectomy (RP)+ extended lymph node dissection

Drug: Neoadjuvant chemotherapy combined with hormone therapyProcedure: Radical Prostatectomy (RP)+ extended lymph node dissection

NHT Group

ACTIVE COMPARATOR

Neoadjuvant hormonal therapy, radical Prostatectomy (RP)+ extended lymph node dissection.

Drug: Neoadjuvant hormone therapyProcedure: Radical Prostatectomy (RP)+ extended lymph node dissection

RP Group

OTHER

Radical Prostatectomy (RP)+ extended lymph node dissection alone.

Procedure: Radical Prostatectomy (RP)+ extended lymph node dissection

Interventions

Neoadjuvant chemotherapy combined with hormone therapyDRUG

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

Also known as: NCHT
NCHT Group
Neoadjuvant hormone therapyDRUG

HT (Bicalutamide Tablets, 50mg QD orally; Goserelin, 3.6mg, subcutaneous injection, q28d), 3-6 cycles

Also known as: NHT
NHT Group
Radical Prostatectomy (RP)+ extended lymph node dissectionPROCEDURE

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.

Also known as: RP+ePLND
NCHT GroupNHT GroupRP Group

Eligibility Criteria

Age18 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≤ Aged \<75 years, male;
  • Histology or cytology diagnosis: Prostate adenocarcinoma;
  • ECOG performance Status ≤1; Expected lifetime ≥10 years;
  • Without clinical or radiographic metastases in 6 months (Bone scan, MRI or pelvic enhanced CT scan, PET-CT) before randomized;
  • 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;
  • Without Androgen Blockade Treatment in 4 weeks before randomized;
  • Without radiographic treatment towards primary tumour;
  • Without opioids (including codeine and dextropropoxyphene) relieving relevant pain of cancer;
  • Without azole drugs (such as fluconazole, itraconazole);
  • Important laboratory indicators are as follows:
  • Haemoglobin ≥90g/L
  • ANC ≥ 1500/μL
  • PLT≥100\*10\^9/L
  • K+≥3.5mmol/L
  • 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 more criteria

You may not qualify if:

  • The pathology result of prostate is neuroendocrine prostate cancer, including small cell carcinoma;
  • Previous cytotoxic chemotherapy or biological therapy for prostate cancer;
  • Contraindications to prednisone, such as active infections or other disorders;
  • Patients with chronic disease needed to be given dose of prednisone (each time 5mg, bid a day) exceed the dose in the study;
  • High blood pressure with poor control of drugs (systolic blood pressure ≥160mmHg or diastolic blood pressure ≥95mmHg);
  • Active or symptomatic viral hepatitis or other chronic liver disease, known infected with human immunodeficiency virus (HIV);
  • A disease history of pituitary or adrenal dysfunction;
  • Patients with active autoimmune disease who need hormone therapy;
  • 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;
  • 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.)
  • Patients with a history of hypersensitivity to Taxanes or docetaxel
  • Patients who are concomitantly receiving strong CYP3A4 inhibitors
  • Other circumstances considered inappropriate by investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (14)

  • Siegel R, Naishadham D, Jemal A. Cancer statistics, 2012. CA Cancer J Clin. 2012 Jan-Feb;62(1):10-29. doi: 10.3322/caac.20138. Epub 2012 Jan 4.

    PMID: 22237781BACKGROUND

  • Qi D, Wu C, Liu F, Gu K, Shi Z, Lin X, Tao S, Xu W, Brendler CB, Zheng Y, Xu J. Trends of prostate cancer incidence and mortality in Shanghai, China from 1973 to 2009. Prostate. 2015 Oct;75(14):1662-8. doi: 10.1002/pros.23046. Epub 2015 Jul 17.

    PMID: 26184773BACKGROUND

  • Mottet N, Bellmunt J, Bolla M, Briers E, Cumberbatch MG, De Santis M, Fossati N, Gross T, Henry AM, Joniau S, Lam TB, Mason MD, Matveev VB, Moldovan PC, van den Bergh RCN, Van den Broeck T, van der Poel HG, van der Kwast TH, Rouviere O, Schoots IG, Wiegel T, Cornford P. EAU-ESTRO-SIOG Guidelines on Prostate Cancer. Part 1: Screening, Diagnosis, and Local Treatment with Curative Intent. Eur Urol. 2017 Apr;71(4):618-629. doi: 10.1016/j.eururo.2016.08.003. Epub 2016 Aug 25.

    PMID: 27568654BACKGROUND

  • Peyromaure M, Debre B, Mao K, Zhang G, Wang Y, Sun Z, Xu D, Jiang J, Sun Y. Management of prostate cancer in China: a multicenter report of 6 institutions. J Urol. 2005 Nov;174(5):1794-7. doi: 10.1097/01.ju.0000176817.46279.93.

    PMID: 16217289BACKGROUND

  • Spahn M, Joniau S, Gontero P, Fieuws S, Marchioro G, Tombal B, Kneitz B, Hsu CY, Van Der Eeckt K, Bader P, Frohneberg D, Tizzani A, Van Poppel H. Outcome predictors of radical prostatectomy in patients with prostate-specific antigen greater than 20 ng/ml: a European multi-institutional study of 712 patients. Eur Urol. 2010 Jul;58(1):1-7; discussion 10-1. doi: 10.1016/j.eururo.2010.03.001. Epub 2010 Mar 17.

    PMID: 20299147BACKGROUND

  • Eggener SE, Scardino PT, Walsh PC, Han M, Partin AW, Trock BJ, Feng Z, Wood DP, Eastham JA, Yossepowitch O, Rabah DM, Kattan MW, Yu C, Klein EA, Stephenson AJ. Predicting 15-year prostate cancer specific mortality after radical prostatectomy. J Urol. 2011 Mar;185(3):869-75. doi: 10.1016/j.juro.2010.10.057. Epub 2011 Jan 15.

    PMID: 21239008BACKGROUND

  • Sfoungaristos S, Kourmpetis V, Fokaefs E, Perimenis P. Neoadjuvant Chemotherapy prior to Radical Prostatectomy for Patients with High-Risk Prostate Cancer: A Systematic Review. Chemother Res Pract. 2013;2013:386809. doi: 10.1155/2013/386809. Epub 2013 Feb 21.

    PMID: 23509625BACKGROUND

  • Ward JF, Slezak JM, Blute ML, Bergstralh EJ, Zincke H. Radical prostatectomy for clinically advanced (cT3) prostate cancer since the advent of prostate-specific antigen testing: 15-year outcome. BJU Int. 2005 Apr;95(6):751-6. doi: 10.1111/j.1464-410X.2005.05394.x.

    PMID: 15794776BACKGROUND

  • Shelley MD, Kumar S, Coles B, Wilt T, Staffurth J, Mason MD. Adjuvant hormone therapy for localised and locally advanced prostate carcinoma: a systematic review and meta-analysis of randomised trials. Cancer Treat Rev. 2009 Nov;35(7):540-6. doi: 10.1016/j.ctrv.2009.05.001. Epub 2009 Jun 2.

    PMID: 19493624BACKGROUND

  • Hu J, Xu H, Zhu W, Wu F, Wang J, Ding Q, Jiang H. Neo-adjuvant hormone therapy for non-metastatic prostate cancer: a systematic review and meta-analysis of 5,194 patients. World J Surg Oncol. 2015 Feb 22;13:73. doi: 10.1186/s12957-015-0503-z.

    PMID: 25884478BACKGROUND

  • Tannock IF, de Wit R, Berry WR, Horti J, Pluzanska A, Chi KN, Oudard S, Theodore C, James ND, Turesson I, Rosenthal MA, Eisenberger MA; TAX 327 Investigators. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med. 2004 Oct 7;351(15):1502-12. doi: 10.1056/NEJMoa040720.

    PMID: 15470213BACKGROUND

  • Thalgott M, Horn T, Heck MM, Maurer T, Eiber M, Retz M, Autenrieth M, Herkommer K, Krause BJ, Gschwend JE, Treiber U, Kubler HR. Long-term results of a phase II study with neoadjuvant docetaxel chemotherapy and complete androgen blockade in locally advanced and high-risk prostate cancer. J Hematol Oncol. 2014 Mar 5;7:20. doi: 10.1186/1756-8722-7-20.

    PMID: 24598155BACKGROUND

  • Prayer-Galetti T, Sacco E, Pagano F, Gardiman M, Cisternino A, Betto G, Sperandio P. Long-term follow-up of a neoadjuvant chemohormonal taxane-based phase II trial before radical prostatectomy in patients with non-metastatic high-risk prostate cancer. BJU Int. 2007 Aug;100(2):274-80. doi: 10.1111/j.1464-410X.2007.06760.x. Epub 2007 Mar 12.

    PMID: 17355369BACKGROUND

  • Sella A, Zisman A, Kovel S, Yarom N, Leibovici D, Lindner A. Neoadjuvant chemohormonal therapy in poor-prognosis localized prostate cancer. Urology. 2008 Feb;71(2):323-7. doi: 10.1016/j.urology.2007.08.060.

    PMID: 18308112BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Central Study Contacts

Wei Xue

CONTACT

08613801931604xuewei@renji.com

Chenfei Chi

CONTACT

08613661633570chichenfei@renji.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized 2:2:1
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2020

First Posted

January 7, 2020

Study Start

January 10, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2024

Last Updated

January 7, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share