Neoadjuvant Therapy of Abiraterone Plus ADT for High Risk Prostate Cancer

NCT04356430 | Unknown Phase 2

• 1 other identifier: IUNU-PC-101
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

High risk prostate cancer (PCa) had worse outcomes on radical treatment results, short-time oncological results, even cancer-specific survival, than those low or mediate risk PCa. Neoadjuvant treatment before radical prostatectomy had been proven to get some 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 androgen deprivation therapy (ADT) with abiraterone in neoadjuvant therapy for surgically resectable high-risk or very high-risk PCa.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• Pathologic Complete Response Rate

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

  up to 8 months

• Proportion of Subjects With Minimal Residual Disease

  The proportion of subjects that have residual tumors with maximum diameter of 5 mm or less after radical prostatectomy

  up to 8 months

Secondary Outcomes (8)

• Rate of Stage Degradation

  up to 8 months

• Rate of Positive Surgical Margins

  up to 8 months

• Rate of Complete Serum Remission

  up to 6 months

• Proportion of subjects without PSA progression

  24 months

• Imaging Response Rate

  up to 8 months

Study Arms (2)

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 robotic assisted radical prostatectomy

Drug: Abiraterone Acetate; Drug: Prednisone; Drug: Goserelin 10.8 mg

ADT alone

EXPERIMENTAL

All subjects in this arm will receive LHRHa alone for 24 weeks before receiving robotic assisted radical prostatectomy. Goserelin 10.8 mg will be administered once per 12 weeks.

Drug: Goserelin 10.8 mg

Interventions

Abiraterone Acetate DRUG

1000 mg orally daily for 24 weeks before robotic assisted radical prostatectomy

ADT with Abiraterone and prednisone

Prednisone DRUG

5 mg oral low dose prednisone, once daily

ADT with Abiraterone and prednisone

Goserelin 10.8 mg DRUG

10.8 mg goserelin hypodermic once per 12 weeks

ADT alone; ADT with Abiraterone and prednisone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be ≥ 18 and ≤75 years of age.
• All patients must have a histologically or cytologically diagnosis of prostate cancer and must be eligible for radical prostatectomy.
• All patients must undergo thorough tumor staging and meet one of the following criteria: 1. multi-parameter MRI or PSMA PET / CT shows clinical staging of primary tumor ≥ T3, 2. Gleason score of primary tumor ≥ 8, 3. prostate specific antigen (PSA) ≥20 ng/ml.
• Eastern Cooperative Oncology Group (ECOG) physical condition score ≤ 1
• Patients must have adequate hematologic function, within 28 days prior to registration as evidenced by: white blood cell (WBC) ≥ 4.0 × 109 / L, platelets≥ 100 × 109 / L, hemoglobin ≥ 9 g / dL, and international normalized ratio (INR) \< 1.5.
• Patients must have adequate hepatic function, within 28 days prior to registration, as evidenced by: total bilirubin (TBIL)≤1.5 x upper limit of normal (ULN),and SGOT (AST) and SGPT (ALT) ≤ 2.5 x ULN.
• Patients must have adequate renal function, within 28 days prior to registration, as evidenced by serum creatinine ≤2×ULN
• 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.

You may not qualify if:

• Patients with prostate having neuroendocrine, small cell, or sarcoma-like features are not eligible.
• Patients with low-risk and medium-risk, localized prostate cancer (the following conditions are met at the same time) are not eligible: multi-parameter MRI or PSMA PET / CT shows clinical staging of primary tumor \< T3, Gleason score of primary tumor \< 8, and prostate specific antigen (PSA) \<20 ng/ml.
• Patients with clinical or radiological evidence of regional or extra-regional lymph node metastases or bone metastases or visceral metastases are not eligible.
• Patients with clinical or radiological evidence of regional or extra-regional lymph node metastases or bone metastases or visceral metastases are not eligible.
• Patients who have previously received androgen deprivation therapy (medical or surgical) or focal treatment of prostate cancer or prostate cancer radiotherapy or prostate cancer chemotherapy are not eligible.
• Patients with severe or uncontrolled concurrent infections are not eligible.
• Patients must not have New York Heart Association Class III or IV congestive heart failure at the time of screening. Patients must not have any thromboembolic event, unstable angina pectoris, myocardial infarction within 6 months prior to registration.
• Patients must not have uncontrolled severe hypertension, persistent uncontrolled diabetes, oxygen-dependent lung disease, chronic liver disease, or HIV infection.
• Patients must not have had other malignancies other than prostate cancer in the past 5 years, but cured basal cell or squamous cell skin cancers can be enrolled.
• Patients with mental illness, mental disability or inability to give informed consent are not eligible.

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (1)

Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University

Nanjing, Jiangsu, 210000, China

Location

Related Publications (1)

• Zhuang J, Wang Y, Zhang S, Fu Y, Huang H, Lyu X, Zhang S, Marra G, Xu L, Qiu X, Guo H. Androgen deprivation therapy plus abiraterone or docetaxel as neoadjuvant therapy for very-high-risk prostate cancer: a pooled analysis of two phase II trials. Front Pharmacol. 2023 Jun 26;14:1217303. doi: 10.3389/fphar.2023.1217303. eCollection 2023.

  PMID: 37435500 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Abiraterone Acetate; Prednisone; 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; Pregnadienediols; 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

• Hongqian Guo, MD

  Nanjing Drum Tower Hospital, affiliated to medical school of Nanjing University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Urology, Drum Tower Hospital, Medical School of Nanjing University

Study Record Dates

• First Submitted: April 12, 2020
• First Posted: April 22, 2020
• Study Start: April 1, 2019
• Primary Completion: March 1, 2021
• Study Completion: December 1, 2023
• Last Updated: December 16, 2022

Record last verified: 2021-12

Locations

CN (1)