Androgen Deprivation Therapy Combined With Docetaxel for High Risk Prostate Cancer

Phase 2

Active, not recruiting

• Conditions: Neoadjuvant Therapy \ High Risk Prostate Cancer \ Docetaxel
• Interventions: Drug: Docetaxel injection; Drug: Triptorelin Pamoate for Injectable Suspension; Drug: Prednisone Acetate Tablets

• Registration Number: NCT04869371
• Lead Sponsor: Hongqian Guo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-12
• Primary Completion: 2020-12-01
• Study First Submitted: 2021-04-09
• Study First Submitted QC: 2021-04-28
• Study First Posted: 2021-05-03
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-24
• Last Update Posted: 2022-12-29
• Study Completion: 2023-01-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 75

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Androgen Deprivation Therapy with Docetaxel	Docetaxel injection	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.
ADT alone	Triptorelin Pamoate for Injectable Suspension	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.
Androgen Deprivation Therapy with Docetaxel	Triptorelin Pamoate for Injectable Suspension	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.
Androgen Deprivation Therapy with Docetaxel	Prednisone Acetate Tablets	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.

Primary Outcome Measures

Name	Time	Method
Pathologic Complete Response Rate	up to 8 months	The proportion of subjects with no morphologically recognizable cancer cell in tumor specimens after radical prostatectomy.
pCR or MRD rate	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 Outcome Measures

Name	Time	Method
Drainage duration (day)	12 month	Length of drainage duration, recorded in day.
Operative time (min)	12 month	The operative time(min) of radical prostatectomy.
biochemical progression-free survival (bPFS)	3 years	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.
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.
Serum complete response rate	after 6 month neoadjuvant therapy and before surgery	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	12 month	The proportion of patients with extracapsular extension on pathologic specimens after neoadjuvant therapy.
Recovery time of urinary continence (day)	12 month	The recovery time of urinary continence (day) after radical prostatectomy, defined as 0 pad/day.
metastasis-free survival (MFS)	5 years	Time from date of randomization to date of evidence of systemic disease on bone scan or cross-sectional imaging.
Rate of Stage Degradation	up to 8 months	Clinical or pathological stage degradation after neoadjuvant therapy
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.
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.
Incidence of complications (%)	12 month	The proportion of subjects who suffer from major complications.
Rate of Positive Surgical Margins	up to 8 months	The proportion of subjects with positive surgical margins after radical prostatectomy.
Rate of positive lymph node	12 month	The proportion of patients with positive lymph node on pathologic specimens after neoadjuvant therapy.

Trial Locations

Locations (1)

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; 🇨🇳 Nanjing, Jiangsu, China