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

February 3, 2021 updated by: Hao Zeng, West China Hospital

A Single-center, Phase II Neoadjuvant Study of Abiraterone Acetate in the Treatment of Intraductal Carcinoma of the Prostate

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）.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

IDC-P is an adverse pathological entity of prostate cancer, characterized by the growth of malignant cells in pre-existing prostatic ducts and acini, and is present in high-grade disease and associated with poor prognosis. Previous studies have shown that IDC-P was significantly associated with an adverse clinical course in patients who received radical prostatectomy or radiotherapy, and the presence of IDC-P on the biopsy specimen was associated with a poor prognosis in terms of overall survival (OS) and a poor docetaxel response in patients with distant metastasis at the initial diagnosis. Our previous researches as well as other published data indicated that abiraterone had a better therapeutic efficacy than docetaxel as the first-line therapy in metastatic castration resistance prostate cancer（mCRPC）with IDC-P. Therefore we intended to perform this single-arm phase II clinical trial to evaluate the initial efficacy and safety of abiraterone acetate Plus ADT as neoadjuvant therapy for high-risk localized prostate cancer with IDC-P. The primary endpoint is the pathologic complete response (pCR).

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • West China Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: Abiraterone acetate
1000 mg orally daily for 24 weeks before radical prostatectomy
Drug: Prednisolone
5 mg oral low dose prednisone, once daily
Drug: Goserelin
10.8 mg goserelin hypodermic once per 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathologic Complete Response Rate（pCR）
Time Frame: 6 months
The proportion of subjects with no morphologically recognizable cancer cell in tumor specimens after radical prostatectomy.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Subjects With Minimal Residual Disease
Time Frame: 6 months
The proportion of subjects that have residual tumors with maximum diameter of 5 mm or less after radical prostatectomy.
6 months
Rate of positive surgical margin (PSM)
Time Frame: 6 months
The rate of positive surgical margins in the prostatectomy specimen after neoadjuvant therapy.
6 months
Rate of Nodal Metastases After 6 Months of Treatment
Time Frame: 6 months
The rate of the presence of tumor cells within surgically excised lymph nodes will be assessed after 6 months of neoadjuvant treatment.
6 months
Rate of Pathologic T3 Disease After 6 Months of Treatment
Time Frame: 6 months
The rate of the presence of T3 disease (e.g. extraprostatic tumor not invading adjacent structures) will be determine from the prostatectomy specimen after 6 months of neoadjuvant treatment.
6 months
Biochemical Progression-free Survival (bPFS)
Time Frame: 2 years
Biochemical progression will be defined per the American Urological Association guidelines (i.e. confirmed prostate-specific antigen post-radical prostatectomy >= 0.2 ng/mL) or death. Will be estimated using Kaplan-Meier methods and 95% CI will be estimated using Greenwood's formula.
2 years
PSA decline rate
Time Frame: 6 months
The rate of PSA decline to baseline PSA after 6 months of neoadjuvant therapy.
6 months
Incidence and severity of adverse events
Time Frame: 6 months
Safety as assessed by the incidence and severity of adverse events and serious adverse events graded according to the National Cancer Institute - Common Terminology Criteria for adverse events (CTCAE) version 4.0.
6 months
Quality of life (QOL) as assessed by FACT-P
Time Frame: Up to 24 months after surgery
The QOL will be measured using the functional assessment of cancer therapy-prostate（FACT-P）. The questionnaires will be administered at baseline, prior to RP and every 3 months for 2 years post RP.
Up to 24 months after surgery
Quality of life as assessed by EQ-5D
Time Frame: Up to 24 months after surgery
The QOL will be measured using the EuroQol five dimensions questionnaire（EQ-5D）. The questionnaires will be administered at baseline, prior to RP and every 3 months for 2 years post RP.
Up to 24 months after surgery
Radiographic progression-free survival (rPFS)
Time Frame: 2 years
Time from surgery to radiographic progression or death
2 years
Overall survival
Time Frame: 5 years
Time from surgery to death due to any cause
5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Magnetic Resonance Imaging Downstaging after Neoadjuvant Therapy
Time Frame: 6 months
The rate of MRI imaging downstaging after neoadjuvant therapy
6 months
Exploratory analysis to correlate tissue expression of PSA, CYP17, Ki67, and AR with pathologic response
Time Frame: 6 months
To correlate the expression of PSA, CYP17, Ki67, and AR by immunohistochemistry with pCR/npCR in the prostatectomy specimen.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West China Hospital

Investigators

  • Principal Investigator: Hao Zeng, Professor, West China Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2021

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

January 29, 2021

First Submitted That Met QC Criteria

January 29, 2021

First Posted (Actual)

February 3, 2021

Study Record Updates

Last Update Posted (Actual)

February 8, 2021

Last Update Submitted That Met QC Criteria

February 3, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20201224
  • Dragon-001 (Other Identifier: Chia Tai Tianqing Pharmaceutical Group Co., LTD)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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