Androgen Deprivation Therapy Combined With Docetaxel for High Risk Prostate Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Drug: Docetaxel injection
75 mg/m2 body surface area every 3 weeks for 6 cycles before robot assisted radical prostatectomy
Drug: Triptorelin Pamoate for Injectable Suspension
15mg every 12 weeks
Drug: Prednisone Acetate Tablets
5 mg oral low dose prednisone, once daily
|
| Active Comparator: 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. |
Drug: Triptorelin Pamoate for Injectable Suspension
15mg every 12 weeks
|
Outcome Measures
Primary Outcome Measures
- Pathologic Complete Response Rate [up to 8 months]
The proportion of subjects with no morphologically recognizable cancer cell in tumor specimens after radical prostatectomy.
- Proportion of Subjects With Minimal Residual Disease [up to 8 months]
The proportion of subjects that have residual tumors with maximum diameter of 3 mm or less after radical prostatectomy.
Secondary Outcome Measures
- Imaging Response Rate [up to 8 months]
The proportion of subjects whose primary tumor is in complete remission on imaging or residual tumor's maximum diameter is less than 0.5cm.
- Residual cancer burden (RCB) [up to 8 months]
Evaluated by Residual Cancer Burden Calculator based on Primary Tumor Bed and Lymph Nodes.
- Rate of Stage Degradation [up to 8 months]
Clinical or pathological stage degradation after neoadjuvant therapy
- Rate of Positive Surgical Margins [up to 8 months]
The proportion of subjects with positive surgical margins after radical prostatectomy.
- Pathological response to treatment [up to 8 months]
Group 0-3, The University of Texas M.D. Anderson Cancer Center evaluation criteria
- Proportion of subjects without PSA progression [up to 8 months]
The proportion of subjects whose PSA has never gone below 1 ng/ml or who receive any radiotherapy or systemic treatment after radical prostatectomy
- Rate of Complete Serum Remission [up to 8 months]
The proportion of subjects whose PSA is less than or equal to 0.2 ng/ml after 6 months of treatment.
- Operative time (min) [12 month]
The operative time(min) of radical prostatectomy.
- Estimated blood loss (ml) [12 month]
Estimated blood loss (ml) during the process of radical prostatectomy.
- Hospital length of stay (day) [12 month]
The hospitalization time, recorded in day.
- Drainage duration (day) [12 month]
Length of drainage duration, recorded in day.
- Incidence of complications (%) [12 month]
The proportion of subjects who suffer from major complications.
- Recovery time of urinary continence (day) [12 month]
The recovery time of urinary continence (day) after radical prostatectomy, defined as 0 pad/day.
Eligibility Criteria
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 ≤ 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 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Nanjing | Jiangsu | China | 210000 |
Sponsors and Collaborators
- Hongqian Guo
Investigators
- Principal Investigator: Hongqian Guo, MD, Nanjing Drum Tower Hospital, affiliated to medical school of Nanjing University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IUNU-PC-106