Clinical trial · Interventional
Neoadjuvant Therapy of Abiraterone Plus ADT for Intraductal Carcinoma of the Prostate
A Single-center, Phase II Neoadjuvant Study of Abiraterone Acetate in the Treatment of Intraductal Carcinoma of the Prostate
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abiraterone acetate | Drug | Abiraterone Acetate | ALIAS |
| Goserelin | Drug | Goserelin | ALIAS |
| Prednisolone | Drug | Prednisolone | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ADT with Abiraterone and prednisone
- description
- 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
- interventionNames
- Drug: Abiraterone acetate
- Drug: Prednisolone
- Drug: Goserelin
Primary outcomes (1)
- measure
- Pathologic Complete Response Rate(pCR)
- timeFrame
- 6 months
- description
- The proportion of subjects with no morphologically recognizable cancer cell in tumor specimens after radical prostatectomy.
Secondary outcomes (11)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * Serum Creatinine ≤ 1.5 x ULN * Creatinine Clearance ≥ 40 mL/min Exclusion Criteria: * 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
References
Publications (11)
- BACKGROUNDSiegel 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. PMID 31912902
- BACKGROUNDHumphrey 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. PMID 26996659
- BACKGROUNDEfstathiou 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. PMID 19853370
- BACKGROUNDVan 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. PMID 22405699
- BACKGROUNDKumar 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
- BACKGROUNDZhao 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. PMID 25307858
- 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.