Back to resultsAndrogen Deprivation Therapy Combined With Docetaxel for High Risk Prostate Cancer
Primary Purpose
Neoadjuvant Therapy \ High Risk Prostate Cancer \ Docetaxel
Status
Active
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Docetaxel injection
Triptorelin Pamoate for Injectable Suspension
Prednisone Acetate Tablets
Sponsored by
About this trial
This is an interventional treatment trial for Neoadjuvant Therapy \ High Risk Prostate Cancer \ Docetaxel
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 ≤ 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.
Sites / Locations
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Androgen Deprivation Therapy with Docetaxel
ADT alone
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Pathologic Complete Response Rate
The proportion of subjects with no morphologically recognizable cancer cell in tumor specimens after radical prostatectomy.
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.
Secondary Outcome Measures
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.
Rate of Stage Degradation
Clinical or pathological stage degradation after neoadjuvant therapy
Rate of Positive Surgical Margins
The proportion of subjects with positive surgical margins after radical prostatectomy.
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.
Operative time (min)
The operative time(min) of radical prostatectomy.
Estimated blood loss (ml)
Estimated blood loss (ml) during the process of radical prostatectomy.
Hospital length of stay (day)
The hospitalization time, recorded in day.
Drainage duration (day)
Length of drainage duration, recorded in day.
Incidence of complications (%)
The proportion of subjects who suffer from major complications.
Recovery time of urinary continence (day)
The recovery time of urinary continence (day) after radical prostatectomy, defined as 0 pad/day.
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.
metastasis-free survival (MFS)
Time from date of randomization to date of evidence of systemic disease on bone scan or cross-sectional imaging.
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.
Rate of extracapsular extension
The proportion of patients with extracapsular extension on pathologic specimens after neoadjuvant therapy.
Rate of positive lymph node
The proportion of patients with positive lymph node on pathologic specimens after neoadjuvant therapy.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04869371
Brief Title
Androgen Deprivation Therapy Combined With Docetaxel for High Risk Prostate Cancer
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 12, 2018 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
January 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hongqian Guo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoadjuvant Therapy \ High Risk Prostate Cancer \ Docetaxel
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Androgen Deprivation Therapy with Docetaxel
Arm Type
Experimental
Arm Description
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.
Arm Title
ADT alone
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Docetaxel injection
Intervention Description
75 mg/m2 body surface area every 3 weeks for 6 cycles before robot assisted radical prostatectomy
Intervention Type
Drug
Intervention Name(s)
Triptorelin Pamoate for Injectable Suspension
Intervention Description
15mg every 12 weeks
Intervention Type
Drug
Intervention Name(s)
Prednisone Acetate Tablets
Intervention Description
5 mg oral low dose prednisone, once daily
Primary Outcome Measure Information:
Title
Pathologic Complete Response Rate
Description
The proportion of subjects with no morphologically recognizable cancer cell in tumor specimens after radical prostatectomy.
Time Frame
up to 8 months
Title
pCR or MRD rate
Description
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
Secondary Outcome Measure Information:
Title
Imaging Response Rate
Description
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
Title
Rate of Stage Degradation
Description
Clinical or pathological stage degradation after neoadjuvant therapy
Time Frame
up to 8 months
Title
Rate of Positive Surgical Margins
Description
The proportion of subjects with positive surgical margins after radical prostatectomy.
Time Frame
up to 8 months
Title
Rate of Complete Serum Remission
Description
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
Title
Operative time (min)
Description
The operative time(min) of radical prostatectomy.
Time Frame
12 month
Title
Estimated blood loss (ml)
Description
Estimated blood loss (ml) during the process of radical prostatectomy.
Time Frame
12 month
Title
Hospital length of stay (day)
Description
The hospitalization time, recorded in day.
Time Frame
12 month
Title
Drainage duration (day)
Description
Length of drainage duration, recorded in day.
Time Frame
12 month
Title
Incidence of complications (%)
Description
The proportion of subjects who suffer from major complications.
Time Frame
12 month
Title
Recovery time of urinary continence (day)
Description
The recovery time of urinary continence (day) after radical prostatectomy, defined as 0 pad/day.
Time Frame
12 month
Title
biochemical progression-free survival (bPFS)
Description
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
Title
metastasis-free survival (MFS)
Description
Time from date of randomization to date of evidence of systemic disease on bone scan or cross-sectional imaging.
Time Frame
5 years
Title
Serum complete response rate
Description
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
Title
Rate of extracapsular extension
Description
The proportion of patients with extracapsular extension on pathologic specimens after neoadjuvant therapy.
Time Frame
12 month
Title
Rate of positive lymph node
Description
The proportion of patients with positive lymph node on pathologic specimens after neoadjuvant therapy.
Time Frame
12 month
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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 ≤ 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongqian Guo, MD
Organizational Affiliation
Nanjing Drum Tower Hospital, affiliated to medical school of Nanjing University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
12. IPD Sharing Statement
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Androgen Deprivation Therapy Combined With Docetaxel for High Risk Prostate Cancer
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