Neoadjuvant Therapy of Abiraterone Plus ADT for Intraductal Carcinoma of the Prostate
NCT ID: NCT04736108
Last Updated: 2021-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
50 participants
INTERVENTIONAL
2021-05-31
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ADT with Abiraterone and prednisone
All subjects in this arm will receive luteinizing hormone releasing hormone analogue (LHRHa) plus abiraterone acetate and prednisone, as per standard of care. Goserelin 10.8 mg will be used once per 12 weeks. Abiraterone acetate will be administered orally as 1000 mg once daily along with 5 mg of oral prednisone once per day. Subjects will continue to take abiraterone acetate and prednisone for 24 weeks before radical prostatectomy
Abiraterone acetate
1000 mg orally daily for 24 weeks before radical prostatectomy
Prednisolone
5 mg oral low dose prednisone, once daily
Goserelin
10.8 mg goserelin hypodermic once per 12 weeks
Interventions
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Abiraterone acetate
1000 mg orally daily for 24 weeks before radical prostatectomy
Prednisolone
5 mg oral low dose prednisone, once daily
Goserelin
10.8 mg goserelin hypodermic once per 12 weeks
Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically diagnosis of prostate cancer with positive IDC-P status
* High-risk localized prostate cancer, defined by either: Tumor stage ≥T3a by digital rectal examination, or Primary tumor Gleason score ≥ 8, or PSA \> 20 ng/mL
* No evidence of metastases
* The ECOG score of the patient is ≤2
* Expected survival over 5 years
* 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
* Agree to collect the tumor tissue and blood samples needed for the research and apply them to related study
* Adequate hematologic, renal and hepatic function:
* Absolute neutrophil count \[ANC\] ≥1.5 x 10\^9/L
* Platelet count \[PLT\] ≥100 x 10\^9/L
* Hemoglobin \[HGB\] ≥9 g/dL
* Serum Total bilirubin \[TBIL\] ≤1.5 x upper limit of normal (ULN)
* Aspartate aminotransferase (AST), alanine aminotransferase (ALT) \< 2.5 x ULN
* Serum albumin \[ALB\] ≥2.8 g/dL
* Serum Creatinine ≤ 1.5 x ULN
* Creatinine Clearance ≥ 40 mL/min
Exclusion Criteria
* Evidence of metastatic disease (M1) on imaging studies
* Pathological finding consistent with small cell, ductal or neuroendocrine carcinoma of the prostate
* Major surgery or severe trauma within 30 days before enrollment
* Patients with severe or uncontrolled concurrent，including but not limited to：
* Severe or uncontrolled concurrent infections
* Human immunodeficiency virus \[HIV\] infection positive
* Suffer from acute or chronic active hepatitis B (HBsAg positive and HBV DNA\>1x10\^3/mL) Or acute or chronic active hepatitis C (HCV antibody positive and HCV RNA\>15 IU/mL)
* Active tuberculosis, etc
* Abnormal cardiac function as manifested by NYHA (New York Heart Association) class III or IV heart failure，or clinically significant ventricular arrhythmias
* Uncontrolled hypertension（Systolic blood pressure≥160mmHg or Diastolic blood pressure≥100mmHg）
* Severe or unstable angina, myocardial infarction，arterial or venous thromboembolic events (eg, pulmonary embolism, cerebrovascular accident including transient ischemic attacks) Occurred within 6 months before enrollment
* Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study
* Any condition that in the opinion of the investigator, would preclude participation in this study
18 Years
MALE
No
Sponsors
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West China Hospital
OTHER
Responsible Party
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Hao Zeng
Professor of Department of Urology
Principal Investigators
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Hao Zeng, Professor
Role: PRINCIPAL_INVESTIGATOR
West China Hospital
Locations
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West China Hospital
Chengdu, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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References
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Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8.
Humphrey PA, Moch H, Cubilla AL, Ulbright TM, Reuter VE. The 2016 WHO Classification of Tumours of the Urinary System and Male Genital Organs-Part B: Prostate and Bladder Tumours. Eur Urol. 2016 Jul;70(1):106-119. doi: 10.1016/j.eururo.2016.02.028. Epub 2016 Mar 17.
Efstathiou E, Abrahams NA, Tibbs RF, Wang X, Pettaway CA, Pisters LL, Mathew PF, Do KA, Logothetis CJ, Troncoso P. Morphologic characterization of preoperatively treated prostate cancer: toward a post-therapy histologic classification. Eur Urol. 2010 Jun;57(6):1030-8. doi: 10.1016/j.eururo.2009.10.020. Epub 2009 Oct 17.
Van der Kwast T, Al Daoud N, Collette L, Sykes J, Thoms J, Milosevic M, Bristow RG, Van Tienhoven G, Warde P, Mirimanoff RO, Bolla M. Biopsy diagnosis of intraductal carcinoma is prognostic in intermediate and high risk prostate cancer patients treated by radiotherapy. Eur J Cancer. 2012 Jun;48(9):1318-25. doi: 10.1016/j.ejca.2012.02.003. Epub 2012 Mar 8.
Kumar S, Shelley M, Harrison C, Coles B, Wilt TJ, Mason MD. Neo-adjuvant and adjuvant hormone therapy for localised and locally advanced prostate cancer. Cochrane Database Syst Rev. 2006 Oct 18;2006(4):CD006019. doi: 10.1002/14651858.CD006019.pub2.
Zhao T, Liao B, Yao J, Liu J, Huang R, Shen P, Peng Z, Gui H, Chen X, Zhang P, Zhu Y, Li X, Wei Q, Zhou Q, Zeng H, Chen N. Is there any prognostic impact of intraductal carcinoma of prostate in initial diagnosed aggressively metastatic prostate cancer? Prostate. 2015 Feb 15;75(3):225-32. doi: 10.1002/pros.22906. Epub 2014 Oct 13.
Chen Z, Chen N, Shen P, Gong J, Li X, Zhao T, Liao B, Liu L, Liu Z, Zhang X, Liu J, Peng Z, Chen X, Xu M, Gui H, Zhang P, Wei Q, Zhou Q, Zeng H. The presence and clinical implication of intraductal carcinoma of prostate in metastatic castration resistant prostate cancer. Prostate. 2015 Sep;75(12):1247-54. doi: 10.1002/pros.23005. Epub 2015 Apr 27.
Zhao J, Shen P, Sun G, Chen N, Liu J, Tang X, Huang R, Cai D, Gong J, Zhang X, Chen Z, Li X, Wei Q, Zhang P, Liu Z, Liu J, Zeng H. The prognostic implication of intraductal carcinoma of the prostate in metastatic castration-resistant prostate cancer and its potential predictive value in those treated with docetaxel or abiraterone as first-line therapy. Oncotarget. 2017 Jul 24;8(33):55374-55383. doi: 10.18632/oncotarget.19520. eCollection 2017 Aug 15.
Porter LH, Lawrence MG, Ilic D, Clouston D, Bolton DM, Frydenberg M, Murphy DG, Pezaro C, Risbridger GP, Taylor RA. Systematic Review Links the Prevalence of Intraductal Carcinoma of the Prostate to Prostate Cancer Risk Categories. Eur Urol. 2017 Oct;72(4):492-495. doi: 10.1016/j.eururo.2017.03.013. Epub 2017 Mar 22.
de Bono JS, Logothetis CJ, Molina A, Fizazi K, North S, Chu L, Chi KN, Jones RJ, Goodman OB Jr, Saad F, Staffurth JN, Mainwaring P, Harland S, Flaig TW, Hutson TE, Cheng T, Patterson H, Hainsworth JD, Ryan CJ, Sternberg CN, Ellard SL, Flechon A, Saleh M, Scholz M, Efstathiou E, Zivi A, Bianchini D, Loriot Y, Chieffo N, Kheoh T, Haqq CM, Scher HI; COU-AA-301 Investigators. Abiraterone and increased survival in metastatic prostate cancer. N Engl J Med. 2011 May 26;364(21):1995-2005. doi: 10.1056/NEJMoa1014618.
James ND, de Bono JS, Spears MR, Clarke NW, Mason MD, Dearnaley DP, Ritchie AWS, Amos CL, Gilson C, Jones RJ, Matheson D, Millman R, Attard G, Chowdhury S, Cross WR, Gillessen S, Parker CC, Russell JM, Berthold DR, Brawley C, Adab F, Aung S, Birtle AJ, Bowen J, Brock S, Chakraborti P, Ferguson C, Gale J, Gray E, Hingorani M, Hoskin PJ, Lester JF, Malik ZI, McKinna F, McPhail N, Money-Kyrle J, O'Sullivan J, Parikh O, Protheroe A, Robinson A, Srihari NN, Thomas C, Wagstaff J, Wylie J, Zarkar A, Parmar MKB, Sydes MR; STAMPEDE Investigators. Abiraterone for Prostate Cancer Not Previously Treated with Hormone Therapy. N Engl J Med. 2017 Jul 27;377(4):338-351. doi: 10.1056/NEJMoa1702900. Epub 2017 Jun 3.
Other Identifiers
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Dragon-001
Identifier Type: OTHER
Identifier Source: secondary_id
20201224
Identifier Type: -
Identifier Source: org_study_id
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