This randomized, controlled, single center clinical trial aims to evaluate the efficacy and safety of Androgen Deprivation Therapy Combined with Docetaxel for High Risk Prostate Cancer with a six-month treatment cycle.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
75
75 mg/m2 body surface area every 3 weeks for 6 cycles before robot assisted radical prostatectomy
15mg every 12 weeks
5 mg oral low dose prednisone, once daily
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Pathologic Complete Response Rate
The proportion of subjects with no morphologically recognizable cancer cell in tumor specimens after radical prostatectomy.
Time frame: up to 8 months
pCR or MRD rate
The proportion of patients with pCR or MRD. Pathologic complete response (pCR): defined as no morphologically recognizable cancer cell in tumor specimens after radical prostatectomy. Minimal Residual Disease (MRD): defined as residual tumors with maximum diameter of 3 mm or less after radical prostatectomy.
Time frame: up to 8 months
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.
Time frame: up to 8 months
Rate of Stage Degradation
Clinical or pathological stage degradation after neoadjuvant therapy
Time frame: up to 8 months
Rate of Positive Surgical Margins
The proportion of subjects with positive surgical margins after radical prostatectomy.
Time frame: up to 8 months
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.
Time frame: up to 8 months
Operative time (min)
The operative time(min) of radical prostatectomy.
Time frame: 12 month
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Estimated blood loss (ml)
Estimated blood loss (ml) during the process of radical prostatectomy.
Time frame: 12 month
Hospital length of stay (day)
The hospitalization time, recorded in day.
Time frame: 12 month
Drainage duration (day)
Length of drainage duration, recorded in day.
Time frame: 12 month
Incidence of complications (%)
The proportion of subjects who suffer from major complications.
Time frame: 12 month
Recovery time of urinary continence (day)
The recovery time of urinary continence (day) after radical prostatectomy, defined as 0 pad/day.
Time frame: 12 month
biochemical progression-free survival (bPFS)
Biochemical progression was defined as two consecutive rising PSA values that were above 0.2ng/ml at least one month apart, or starting adjuvant therapy after surgery including radiotherapy, ADT or anti-androgen therapy. The time for bPFS was measured from randomization to biochemical progression or death from any cause.
Time frame: 3 years
metastasis-free survival (MFS)
Time from date of randomization to date of evidence of systemic disease on bone scan or cross-sectional imaging.
Time frame: 5 years
Serum complete response rate
Serum complete response rate, defined as the proportion of participants with PSA ≤ 0.1 ng/mL after 6-month neoadjuvant therapy.
Time frame: after 6 month neoadjuvant therapy and before surgery
Rate of extracapsular extension
The proportion of patients with extracapsular extension on pathologic specimens after neoadjuvant therapy.
Time frame: 12 month
Rate of positive lymph node
The proportion of patients with positive lymph node on pathologic specimens after neoadjuvant therapy.
Time frame: 12 month