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).
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
1000 mg orally daily for 24 weeks before radical prostatectomy
5 mg oral low dose prednisone, once daily
10.8 mg goserelin hypodermic once per 12 weeks
West China Hospital
Chengdu, Sichuan, China
Pathologic Complete Response Rate(pCR)
The proportion of subjects with no morphologically recognizable cancer cell in tumor specimens after radical prostatectomy.
Time frame: 6 months
Rate 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.
Time frame: 6 months
Rate of positive surgical margin (PSM)
The rate of positive surgical margins in the prostatectomy specimen after neoadjuvant therapy.
Time frame: 6 months
Rate of Nodal Metastases After 6 Months of Treatment
The rate of the presence of tumor cells within surgically excised lymph nodes will be assessed after 6 months of neoadjuvant treatment.
Time frame: 6 months
Rate of Pathologic T3 Disease After 6 Months of Treatment
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.
Time frame: 6 months
Biochemical Progression-free Survival (bPFS)
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.
Time frame: 2 years
PSA decline rate
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The rate of PSA decline to baseline PSA after 6 months of neoadjuvant therapy.
Time frame: 6 months
Incidence and severity of adverse events
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.
Time frame: 6 months
Quality of life (QOL) as assessed by FACT-P
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.
Time frame: Up to 24 months after surgery
Quality of life as assessed by EQ-5D
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.
Time frame: Up to 24 months after surgery
Radiographic progression-free survival (rPFS)
Time from surgery to radiographic progression or death
Time frame: 2 years
Overall survival
Time from surgery to death due to any cause
Time frame: 5 years