Neoadjuvant Therapy of Abiraterone Plus ADT for Intraductal Carcinoma of the Prostate

NCT04736108 | Unknown Phase 2

• 2 other identifiers: 20201224Dragon-001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Neoadjuvant treatment before radical prostatectomy has been proven to provide benefits on peri-operation results, especially on reduction of tumor volume and minimization of biochemical recurrence. This study will evaluate the efficacy and safety of abiraterone acetate Plus androgen deprivation therapy（ADT）in high-risk localized prostate cancer with intraductal carcinoma of the prostate（IDC-P）.

Conditions

Prostate Cancer

Keywords

abiraterone acetate

Outcome Measures

Primary Outcomes (1)

• Pathologic Complete Response Rate（pCR）

  The proportion of subjects with no morphologically recognizable cancer cell in tumor specimens after radical prostatectomy.

  6 months

Secondary Outcomes (11)

• Rate of Subjects With Minimal Residual Disease

  6 months

• Rate of positive surgical margin (PSM)

  6 months

• Rate of Nodal Metastases After 6 Months of Treatment

  6 months

• Rate of Pathologic T3 Disease After 6 Months of Treatment

  6 months

• Biochemical Progression-free Survival (bPFS)

  2 years

Other Outcomes (2)

• Rate of Magnetic Resonance Imaging Downstaging after Neoadjuvant Therapy

  6 months

• Exploratory analysis to correlate tissue expression of PSA, CYP17, Ki67, and AR with pathologic response

  6 months

Study Arms (1)

ADT with Abiraterone and prednisone

EXPERIMENTAL

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

Drug: Abiraterone acetate; Drug: Prednisolone; Drug: Goserelin

Interventions

Abiraterone acetate DRUG

1000 mg orally daily for 24 weeks before radical prostatectomy

ADT with Abiraterone and prednisone

Prednisolone DRUG

5 mg oral low dose prednisone, once daily

ADT with Abiraterone and prednisone

Goserelin DRUG

10.8 mg goserelin hypodermic once per 12 weeks

ADT with Abiraterone and prednisone

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only male patient can enter this study
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• 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

You may not qualify if:

• Prior androgen deprivation therapy (medical or surgical), radiation therapy or chemotherapy for prostate cancer
• 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

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 610000, China

Location

Related Publications (11)

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  PMID: 22405699 BACKGROUND

• 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.

  PMID: 17054269 BACKGROUND

• 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.

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• 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.

  PMID: 25917338 BACKGROUND

• 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.

  PMID: 28903426 BACKGROUND

• 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.

  PMID: 28342640 BACKGROUND

• 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.

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• 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.

  PMID: 28578639 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Abiraterone Acetate; Prednisolone; Goserelin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Hao Zeng, Professor

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hao Zeng, Professor

CONTACT

008618980602129; kucaizeng@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Department of Urology

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: February 3, 2021
• Study Start: May 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: December 1, 2024
• Last Updated: February 8, 2021

Record last verified: 2021-02

Locations

CN (1)