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Trial Title:
Comparing the Efficacy and Safety of Rezvilutamide+ADT+Docetaxel Versus Rezvilutamide +ADT in the mHSPC
NCT ID:
NCT05983783
Condition:
Metastatic Prostate Cancer
Hormone Sensitive Prostate Cancer
Chemotherapy Effect
Conditions: Official terms:
Prostatic Neoplasms
Hypersensitivity
Docetaxel
Conditions: Keywords:
Rezvilutamide
mHPSC
chemotherapy
Androgen deprivation therapy
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Docetaxel
Description:
This is Triple drug regimen for mHSPC
Arm group label:
Rezvilutamide+ADT+Docetaxel
Other name:
Rezvilutamide
Intervention type:
Drug
Intervention name:
Rezvilutamide
Description:
This is doubling drug regimen for mHSPC
Arm group label:
Rezvilutamide+ADT
Other name:
ADT
Summary:
Evaluate whether the combination of Rezvilutamide and androgen deprivation therapy (ADT)
with docetaxel improves overall survival (OS) in patients with metastatic
hormone-sensitive prostate cancer (mHSPC) compared to the combination of Rezvilutamide
and ADT.
Detailed description:
To investigate the value of chemotherapy in the treatment of high-burden of mHSPC on the
background of next-genertion of AR inhibitors.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Males aged ≥40 years and ≤80 years.
2. Histologically or cytologically confirmed prostate adenocarcinoma.
3. Metastatic disease.
4. Eligible for ADT and Docetaxel.
5. Started or not started first-generation androgen deprivation therapy (ADT), but not
exceeding 12 weeks before randomization.
6. ECOG score of 0 or 1.
7. Laboratory tests meet the following requirements:
- Hematology: neutrophils ≥1.5×10^9/L, platelets ≥100×10^9/L, hemoglobin ≥9g/dL.
- Renal function: serum creatinine ≤1.5× upper limit of normal (ULN).
- Liver function: aspartate aminotransferase (AST) and alanine aminotransferase
(ALT) ≤2.5× ULN, total bilirubin (TBIL) ≤1.5× ULN.
- Coagulation function: international normalized ratio (INR) <1.5.
8. Study subjects: Patients with mHSPC have a confirmed pathology of prostate
adenocarcinoma with high tumor burden, which is defined by having at least one of
the following conditions:
1) Bone scan showing ≥4 bone metastatic lesions (with at least one site outside the
pelvis or spine).
2) CT/MRI revealing visceral metastatic lesions (excluding lymph nodes).
Exclusion Criteria:
Patients who meet any of the following criteria are not eligible to participate in this
study:
1. Prior use of LHRH agonists/antagonists; second-generation androgen receptor (AR)
inhibitors such as enzalutamide, ARN-509, darolutamide (ODM-201), or other
investigational AR inhibitors; CYP17 enzyme inhibitors such as abiraterone acetate
or oral ketoconazole for anti-tumor treatment of prostate cancer; chemotherapy or
immunotherapy for prostate cancer prior to randomization.
2. Received radiation therapy/radiopharmaceutical treatment within 2 weeks before
randomization.
3. Any of the following conditions within 6 months before randomization: stroke,
myocardial infarction, severe/unstable angina pectoris, coronary artery/peripheral
artery bypass surgery, congestive heart failure (New York Heart Association class
III or IV).
4. Previous malignancy, except adequately treated basal cell carcinoma or squamous cell
carcinoma of the skin or superficial bladder cancer not invading the deeper muscle
layer (i.e., pTis, pTa, and pT1) and any other cancer in complete remission for at
least 5 years before randomization.
5. Gastrointestinal diseases or procedures that are expected to significantly interfere
with the absorption of study treatment.
6. Inability to take oral medication.
Gender:
Male
Minimum age:
40 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Urology dpt, First Affiliated Hospital of Nanjing Medical University
Address:
City:
Nanjing
Zip:
210029
Country:
China
Status:
Recruiting
Contact:
Last name:
Shangqian Wang, M.D.,PhD.
Phone:
68303186
Email:
wsq5501@126.com
Investigator:
Last name:
Lixin Hua, M.D.
Email:
Principal Investigator
Start date:
August 1, 2023
Completion date:
December 31, 2027
Lead sponsor:
Agency:
The First Affiliated Hospital with Nanjing Medical University
Agency class:
Other
Source:
The First Affiliated Hospital with Nanjing Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05983783
