Neoadjuvant Therapy of Abiraterone Plus ADT for High Risk Prostate Cancer

NCT ID: NCT04356430

Last Updated: 2022-12-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2023-12-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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 robotic assisted radical prostatectomy

Group Type: EXPERIMENTAL

Abiraterone Acetate

Intervention Type: DRUG

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

Prednisone

Intervention Type: DRUG

5 mg oral low dose prednisone, once daily

Goserelin 10.8 mg

Intervention Type: DRUG

10.8 mg goserelin hypodermic once per 12 weeks

ADT alone

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.

Group Type: EXPERIMENTAL

Goserelin 10.8 mg

Intervention Type: DRUG

10.8 mg goserelin hypodermic once per 12 weeks

Interventions

Abiraterone Acetate

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

Intervention Type: DRUG

Prednisone

5 mg oral low dose prednisone, once daily

Intervention Type: DRUG

Goserelin 10.8 mg

10.8 mg goserelin hypodermic once per 12 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role: lead

Responsible Party

Hongqian Guo

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hongqian Guo, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Nanjing, Jiangsu, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 37435500 (View on PubMed)

Other Identifiers

IUNU-PC-101

Identifier Type: -

Identifier Source: org_study_id