This is a prospective, multicenter, multi-arm, non-randomized, open-label clinical trial to evaluate the efficacy and safety of neoadjuvant intense endocrine therapy for high-risk or locally advanced prostate cancer.
The study was designed to evaluate the efficacy and safety of different forms of neoadjuvant intense androgen deprivation therapy (ADT) compared with ADT alone, followed by prostatectomy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
900
The ADT regimen will be determined by the investigators at separate centers. The dose and frequency of administration will be consistent with the prescribing information. Available drugs include triptorelin, goserelin, leuprolide, digareke ect.
1000 mg (250 mg×4 tablets) once daily, orally
5 mg once daily, orally.
160 mg (40 mg× 4 tablets) once daily, orally.
240 mg (60 mg×4 tablets) once daily, orally.
600 mg (300 mg × 2 tablets) twice daily, orally.
240 mg (80 mg × 3 tablets) once daily orally
The PARP inhibitors will be determined by the investigators at separate centers. The dosage and frequency of administration will be consistent with the prescribing information. Available drugs include olaparib, fluzoparib, pamiparib, talazoparib ect.
Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy.
Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University
Nanjing, Jiangsu, China
RECRUITINGPathologic response rate
Pathologic response rate= Pathologic Complete Response (pCR) Rate + Minimal Residual Disease (MRD) rate
Time frame: up to 3 years
3 year biochemical progression free survival (bPFS)
Biochemical progression free survival (bPFS) within 3 years
Time frame: up to 3 years
Metastasis-Free Survival (MFS)
Metastasis-Free Survival (MFS) after intense neoadjuvant therapy
Time frame: up to 5 years
Time to castration-resistant prostate cancer(CRPC)
Time to castration-resistant prostate cancer(CRPC) after intense neoadjuvant therapy
Time frame: up to 5 years
PSA response rate
Prostate specific antigen (PSA) drops ≥ 98% after intense neoadjuvant therapy
Time frame: up to 3 years
Positive margin rate
The positive margin rate of whole-mount pathology for prostatectomy after intense neoadjuvant therapy
Time frame: up to 6 months
Pathologic downgrade rate
The pathologic downgrade rate of whole-mount pathology for prostatectomy after intense neoadjuvant therapy compared with initial T stage.
Time frame: up to 6 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0. All grades of adverse events will be documented.
Time frame: up to 5 years
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