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Prostate CancerNCT04220398

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

A study testing Neoadjuvant chemotherapy combined with hormone therapy, Neoadjuvant hormone therapy and Radical Prostatectomy (RP)+ extended lymph node dissection in people with Prostate Cancer and Chemotherapy Effect, run by RenJi Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years, men only
What is being tested?
Neoadjuvant chemotherapy combined with hormone therapy, Neoadjuvant hormone therapy and Radical Prostatectomy (RP)+ extended lymph node dissection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
475 participants
Where
No sites listed yet
Study dates
10 Jan 2020to 31 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18≤ 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;
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  • 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
  • ALB≥30g / L
  • calculated Ccr>60 ml/min, serum creatinine ≤ ULN
  • Without swallowing disease, able to swallow the whole piece of drugs;
  • Without other tumour chemotherapy history, without chemotherapy and endocrine therapy contraindications;
  • 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.
  • 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.

Who cannot join

  • 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);
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  • 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.

Trial locations and contacts

No sites are listed yet.

Wei Xue contact

08613801931604

xuewei@renji.com

Chenfei Chi contact

08613661633570

chichenfei@renji.com

About this study

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

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.

Read the 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

Being tested
Neoadjuvant chemotherapy combined with hormone therapy, Neoadjuvant hormone therapy, Radical Prostatectomy (RP)+ extended lymph node dissection
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neoadjuvant chemotherapy combined with hormone therapyDrug

    Also called NCHT

    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

  • Neoadjuvant hormone therapyDrug

    Also called NHT

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

  • Radical Prostatectomy (RP)+ extended lymph node dissectionProcedure or surgery

    Also called RP+ePLND

    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.

Study groups in NCT04220398
Study groupRoleWhat they receive
NCHT GroupExperimentalNeoadjuvant chemotherapy combined with hormone therapy, Radical Prostatectomy (RP)+ extended lymph node dissection
Receives: Drug: Neoadjuvant chemotherapy combined with hormone therapy; Procedure: Radical Prostatectomy (RP)+ extended lymph node dissection
NHT GroupActive comparatorNeoadjuvant hormonal therapy, radical Prostatectomy (RP)+ extended lymph node dissection.
Receives: Drug: Neoadjuvant hormone therapy; Procedure: Radical Prostatectomy (RP)+ extended lymph node dissection
RP GroupOtherRadical Prostatectomy (RP)+ extended lymph node dissection alone.
Receives: Procedure: Radical Prostatectomy (RP)+ extended lymph node dissection

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: about 2 years

Secondary outcomes (5)

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

    The ratio of patients whose consecutive postoperative PSA <0.2ng/ml within 1-year.

    Measured: 1 year

  2. Overall survival (OS)

    The time from randomization to death due to all causes.

    Measured: 5-10 years

  3. Radiographic progression-free survival (rPFS)

    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.

    Measured: 3-5 years

  4. TTPP

    The time from randomization to the time when PSA increased by 25%.

    Measured: 1-3 years

  5. ECOG score progression-free survival

    The time from treatment to the time of ECOG score progression.

    Measured: 3-5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2020
  2. Study start10 Jan 2020 (estimated)
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized 2:2:1
Masking
None (open label)
Enrolment
475 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04220398
Sponsor's protocol ID
PCANT-20
Status last verified
Jan 2020
First submitted
2 Jan 2020
Last updated
7 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 22237781

  • 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.

    PubMed 26184773

  • 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.

    PubMed 27568654

  • 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.

    PubMed 16217289

  • 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.

    PubMed 20299147

  • 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.

    PubMed 21239008

  • 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.

    PubMed 23509625

  • 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.

    PubMed 15794776

  • 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.

    PubMed 19493624

  • 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.

    PubMed 25884478

  • 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.

    PubMed 15470213

  • 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.

    PubMed 24598155

  • 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.

    PubMed 17355369

  • 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.

    PubMed 18308112

Questions about this trial

What is this clinical trial studying?

A study testing Neoadjuvant chemotherapy combined with hormone therapy, Neoadjuvant hormone therapy and Radical Prostatectomy (RP)+ extended lymph node dissection in people with Prostate Cancer and Chemotherapy Effect, run by RenJi Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Wei Xue (08613801931604, xuewei@renji.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

bPFS (Biochemical progression-free survival) (time frame: about 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04220398, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2020.

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