Neoadjuvant Therapy of Abiraterone Plus ADT for High Risk Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Medical Ethics Committee of Nanjing Drum Tower Hospital Affiliated to Medical School of Nanjing University

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04356430
• Other study ID #: IUNU-PC-101
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: April 1, 2019
• Est. completion date: December 1, 2023

Study information

• Verified date: December 2021
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 75
• Est. completion date: December 1, 2023
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Abiraterone Acetate
1000 mg orally daily for 24 weeks before robotic assisted radical prostatectomy
• Prednisone
5 mg oral low dose prednisone, once daily
• Goserelin 10.8 mg
10.8 mg goserelin hypodermic once per 12 weeks

Locations

Country	Name	City	State
China	Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathologic Complete Response Rate	The proportion of subjects with no morphologically recognizable cancer cell in tumor specimens after radical prostatectomy	up to 8 months
Primary	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	Rate of Stage Degradation	Clinical or pathological stage degradation after neoadjuvant therapy	up to 8 months
Secondary	Rate of Positive Surgical Margins	The proportion of subjects with positive surgical margins after radical prostatectomy	up to 8 months
Secondary	Rate of Complete Serum Remission	The proportion of subjects whose PSA is less than or equal to 0.2 ng/ml after 6 months of treatment	up to 6 months
Secondary	Proportion of subjects without PSA progression	The proportion of subjects whose PSA has never gone below 1 ng/ml or who receive any radiotherapy or systemic treatment after radical prostatectomy	24 months
Secondary	Imaging Response Rate	The proportion of subjects whose primary tumor is in complete remission on imaging or residual tumor's maximum diameter is less than 0.5cm	up to 8 months
Secondary	Recovery time of urinary continence (day)	The recovery time of urinary continence (day) after radical prostatectomy, defined as 0 pad/day.	12 month
Secondary	biochemical recurrence-free survival (bRFS)	biochemical recurrence-free survival (bRFS) defined as time to PSA = 0.2 ng/ml after radical prostatectomy.	3 years
Secondary	metastasis-free survival (MFS)	time from date of randomization to date of evidence of systemic disease on bone scan or cross-sectional imaging.	5 years