A Randomized, Controlled, Single Center Clinical Trial to Evaluate the Efficacy and Safety of Neoadjuvant Therapy With Androgen Deprivation Therapy Combined With Docetaxel for High Risk and Very High Risk Prostate Cancer
Overview
- Phase
- Phase 2
- Intervention
- Docetaxel injection
- Conditions
- Neoadjuvant Therapy \ High Risk Prostate Cancer \ Docetaxel
- Sponsor
- Hongqian Guo
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Pathologic Complete Response Rate
- Status
- Active, Not Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Investigators
Hongqian Guo
chief physician
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
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:
- •multi-parameter MRI or PSMA PET / CT shows clinical staging of primary tumor ≥ T3,
- •Gleason score of primary tumor ≥ 8, 3.prostate specific antigen (PSA) ≥20 ng/ml.
- •Eastern Cooperative Oncology Group (ECOG) physical condition score ≤
- •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.
- •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 toregistration, 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: multiparameter 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 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.
Arms & Interventions
Androgen Deprivation Therapy with Docetaxel
All subjects in this arm will receive luteinizing hormone releasing hormone analogue (LHRHa) plus docetaxel and prednisone, as per standard of care. Triptorelin pamoate (Diphereline) 15mg will be used once per 12 weeks. Docetaxel (75 mg/m2 body surface area) will be administered as intravenous drip every 3 weeks for 6 cycles. Robot assisted radical prostatectomy will be followed in 2 weeks when 24-week treatment cycle is finished.
Intervention: Docetaxel injection
Androgen Deprivation Therapy with Docetaxel
All subjects in this arm will receive luteinizing hormone releasing hormone analogue (LHRHa) plus docetaxel and prednisone, as per standard of care. Triptorelin pamoate (Diphereline) 15mg will be used once per 12 weeks. Docetaxel (75 mg/m2 body surface area) will be administered as intravenous drip every 3 weeks for 6 cycles. Robot assisted radical prostatectomy will be followed in 2 weeks when 24-week treatment cycle is finished.
Intervention: Triptorelin Pamoate for Injectable Suspension
Androgen Deprivation Therapy with Docetaxel
All subjects in this arm will receive luteinizing hormone releasing hormone analogue (LHRHa) plus docetaxel and prednisone, as per standard of care. Triptorelin pamoate (Diphereline) 15mg will be used once per 12 weeks. Docetaxel (75 mg/m2 body surface area) will be administered as intravenous drip every 3 weeks for 6 cycles. Robot assisted radical prostatectomy will be followed in 2 weeks when 24-week treatment cycle is finished.
Intervention: Prednisone Acetate Tablets
ADT alone
All subjects in this arm will receive LHRHa alone for 24 weeks before receiving robot assisted radical prostatectomy. Triptorelin Pamoate 15mg will be administered once per 12 weeks.
Intervention: Triptorelin Pamoate for Injectable Suspension
Outcomes
Primary Outcomes
Pathologic Complete Response Rate
Time Frame: up to 8 months
The proportion of subjects with no morphologically recognizable cancer cell in tumor specimens after radical prostatectomy.
pCR or MRD rate
Time Frame: up to 8 months
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.
Secondary Outcomes
- Operative time (min)(12 month)
- biochemical progression-free survival (bPFS)(3 years)
- Imaging Response Rate(up to 8 months)
- Serum complete response rate(after 6 month neoadjuvant therapy and before surgery)
- Rate of extracapsular extension(12 month)
- Rate of Stage Degradation(up to 8 months)
- Rate of Complete Serum Remission(up to 8 months)
- Estimated blood loss (ml)(12 month)
- Hospital length of stay (day)(12 month)
- Drainage duration (day)(12 month)
- Recovery time of urinary continence (day)(12 month)
- metastasis-free survival (MFS)(5 years)
- Incidence of complications (%)(12 month)
- Rate of positive lymph node(12 month)
- Rate of Positive Surgical Margins(up to 8 months)