Clinical trial NCT04869371: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Neoadjuvant Therapy \ High Risk Prostate Cancer \ Docetaxel
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2021-05-03
Enrollment: 75
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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:

  1. multi-parameter MRI or PSMA PET / CT shows clinical staging of primary tumor ≥ T3,
  2. Gleason score of primary tumor ≥ 8, 3.prostate specific antigen (PSA) ≥20 ng/ml.
  3. Eastern Cooperative Oncology Group (ECOG) physical condition score ≤ 1.
  4. 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.
  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.
  6. 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.

Primary outcomes:
measure: Pathologic Complete Response Rate
timeFrame: up to 8 months
measure: pCR or MRD rate
timeFrame: up to 8 months
Secondary outcomes:
measure: Imaging Response Rate
timeFrame: up to 8 months
measure: Rate of Stage Degradation
timeFrame: up to 8 months
measure: Rate of Positive Surgical Margins
timeFrame: up to 8 months
measure: Rate of Complete Serum Remission
timeFrame: up to 8 months
measure: Operative time (min)
timeFrame: 12 month
measure: Estimated blood loss (ml)
timeFrame: 12 month
measure: Hospital length of stay (day)
timeFrame: 12 month
measure: Drainage duration (day)
timeFrame: 12 month
measure: Incidence of complications (%)
timeFrame: 12 month
measure: Recovery time of urinary continence (day)
timeFrame: 12 month
measure: biochemical progression-free survival (bPFS)
timeFrame: 3 years
measure: metastasis-free survival (MFS)
timeFrame: 5 years
measure: Serum complete response rate
timeFrame: after 6 month neoadjuvant therapy and before surgery
measure: Rate of extracapsular extension
timeFrame: 12 month
measure: Rate of positive lymph node
timeFrame: 12 month
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
state: Jiangsu
Study officials:
affiliation: Nanjing Drum Tower Hospital, affiliated to medical school of Nanjing University
name: Hongqian Guo, MD
role: PRINCIPAL_INVESTIGATOR
References: