Trial Title:
Efficacy and Safety of Apantamide Combined With Docetaxel and ADT vs. Apantamide Combined With ADT in Patients With High Tumor Burden mHSPC: a Multicenter and Prospective Cohort Study
NCT ID:
NCT05713578
Condition:
Cohort Studies
Conditions: Official terms:
Docetaxel
Conditions: Keywords:
cohort study
apantamide
docetaxel
ADT
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Experimental: apantamide+docetaxel+ADT;Active.Comparator: apantamide+ADT treatment
Primary purpose:
Treatment
Masking:
Double (Participant, Care Provider)
Intervention:
Intervention type:
Drug
Intervention name:
apantamide+docetaxel+ADT
Description:
Apantamide, 240 mg (4 × 60 mg tablets), once a day, orally; ADT regimen was treated with
gonadotropin releasing hormone analog (GnRHa), including GnRHa agonist or GnRHa
antagonist. The type, frequency and dose of ADT to be used in each research center are
determined by the investigator; The treatment of docetaxel was started within 6 weeks
after the treatment of apantamide and ADT. The single dose of docetaxel was 75 mg/m2,
intravenous drip for 1 hour, repeated every 3 weeks, and docetaxel lasted for 6 cycles.
Arm group label:
apantamide+docetaxel+ADT
Intervention type:
Drug
Intervention name:
apantamide+ADT treatment
Description:
apantamide+ADT treatment
Arm group label:
apantamide+ADT treatment
Summary:
This is a multicenter, prospective, cohort study to evaluate the efficacy and safety of
apantamide+docetaxel+ADT versus apantamide+ADT in the treatment of patients with high
tumor mHSPC.220 patients with high tumor mHSPC will be included and divided into two
treatment groups according to the treatment plan:Treatment group 1:
apantamide+docetaxel+ADT,Treatment group 2: apantamide+ADT treatment.The study continued
treatment until the patient could not obtain clinical benefits or had intolerable toxic
reactions or the patient withdrew the informed consent, whichever occurred first.
Detailed description:
This is a multicenter, prospective, cohort study to evaluate the efficacy and safety of
apantamide+docetaxel+ADT versus apantamide+ADT in the treatment of patients with high
tumor mHSPC.220 patients with high tumor mHSPC will be included and divided into two
treatment groups according to the treatment plan:
Treatment group 1: apantamide+docetaxel+ADT
Patients were treated with apantamide+docetaxel+ADT after enrollment. The patient
received each drug treatment according to the instructions. The dosage is adjusted
according to the adverse reaction (according to the instructions).Apantamide, 240 mg (4 ×
60 mg tablets), once a day, orally;ADT regimen was treated with gonadotropin releasing
hormone analog (GnRHa), including GnRHa agonist or GnRHa antagonist. The type, frequency
and dose of ADT to be used in each research center are determined by the investigator;The
treatment of docetaxel was started within 6 weeks after the treatment of apantamide and
ADT. The single dose of docetaxel was 75 mg/m2, intravenous drip for 1 hour, repeated
every 3 weeks, and docetaxel lasted for 6 cycles. It is up to the researcher to decide
whether to use prednisone or prednisolone. To prevent docetaxel related hypersensitivity
and fluid retention, oral administration of 8 mg dexamethasone is recommended 12 hours, 3
hours and 1 hour before infusion of docetaxel.The study continued treatment until the
patient could not obtain clinical benefits or had intolerable toxic reactions or the
patient withdrew the informed consent, whichever occurred first.
Treatment group 2: apantamide+ADT treatment
Patients were treated with apantamide and ADT after enrollment. The patient received each
drug treatment according to the instructions. The dosage is adjusted according to the
adverse reaction (according to the instructions)Apantamide, 240 mg (4 × 60 mg tablets),
once a day, orally;ADT regimen was treated with gonadotropin releasing hormone analog
(GnRHa), including GnRHa agonist or GnRHa antagonist. The type, frequency and dose of ADT
used in each research center are determined by the investigator.The study continued
treatment until the patient could not obtain clinical benefits or had intolerable toxic
reactions or the patient withdrew the informed consent, whichever occurred first.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age ≥ 18 years, male;
2. It was diagnosed as prostate adenocarcinoma by histological or cytological
examination, and its pathological type was adenocarcinoma;
3. Bone imaging, CT or MRI showed ≥ 4 bone metastases (≥ 1 bone metastasis located
outside the pelvis or spine) or visceral metastasis;
4. .Patients with recurrence after new or local treatment are sensitive to endocrine
therapy;
5. Patients receiving ADT treatment (drug or surgical castration), with or without the
first generation of antiandrogen drugs, for no more than 3 months, and without
evidence of soft tissue imaging disease progression (according to RECIST 1.1
standard) or clinically significant PSA increase (after serum testosterone reaches
the castration level, PSA increases by 50% from the lowest level), are allowed to be
included in the group;
6. Plan to receive docetaxel combined with apantamide and ADT or apantamide combined
with ADT;
7. ECOG PS score 0-1;
8. Adequate hematology and organ function:
Adequate bone marrow function (no blood transfusion, no use of granulocyte colony
stimulating factor): absolute neutrophil count (ANC) ≥ 1.5 × 109/L（1500/ μ L）；
Hemoglobin ≥ 90 g/L (9.0 g/dL); Platelet count ≥ 100 × 109/L（100, 000/ μ L）；
Adequate liver function: total bilirubin (TBIL) ≤ 1.5 × ULN； AST, ALT and alkaline
phosphatase (ALP) ≤ 2.5 times the upper limit of normal value (ULN);
Adequate renal function: serum creatinine ≤ 1.5 times the upper limit of normal
(ULN) or calculated creatinine clearance ≥ 30 mL/min (calculated using Cockcroft
Gault formula);
9. Sufficient coagulation function (without anticoagulation treatment): International
normalized ratio (INR) ≤ 1.5;
Exclusion Criteria:
1. Have a history of hypersensitivity or intolerance to any drug used in the study;
2. Plan to receive any other anti-tumor treatment during the study period;
3. Patients who have received the second generation of androgen receptor (AR)
inhibitors in the past, such as apantamide, enzalutamide, darotamide (ODM-201) or
other AR inhibitors, CYP17 enzyme inhibitors, such as abietron acetate or oral
ketoconazole, chemotherapy or immunotherapy, as well as adjuvant or new adjuvant
therapy, should also be excluded;
4. Four weeks before the start of the study, he received plant drugs (such as saw
palmetto) that have the effect of anti prostate cancer or reducing PSA level;
5. Have a history of epileptic seizures, a history of medication that can reduce the
threshold of epileptic seizures, or a disease that can induce epileptic seizures
within 12 months before the start of the study and treatment (including a history of
transient ischemic attacks, cerebral apoplexy, brain trauma and disturbance of
consciousness requiring hospitalization);
6. There were active heart diseases within 6 months before the start of study
treatment, including severe/unstable angina, myocardial infarction, congestive heart
failure [NYHA III or IV], or arrhythmias requiring drug treatment;
7. There is inability to swallow, chronic diarrhea, intestinal obstruction or other
factors affecting drug administration and absorption;
8. Have a history of immunodeficiency (including HIV test positive, other acquired and
congenital immunodeficiency diseases) or organ transplantation;
9. Known brain metastasis;
10. Malignant tumors other than prostate cancer in the past 5 years or at the same time,
except for cured skin basal cell carcinoma and cervical carcinoma in situ;
11. Those who are receiving any other experimental drugs or experimental medical
devices;
12. Poor compliance, difficult to cooperate with treatment and follow-up;
13. The investigator believes that the patient has concomitant diseases (such as poorly
controlled hypertension, serious diabetes, neurological or mental diseases, etc.)
that seriously endanger the patient's safety, may confuse the research results, or
affect the patient to complete the study, or any other situation.
Gender:
All
Minimum age:
18 Years
Maximum age:
90 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Qilu hospital
Address:
City:
Jinan
Zip:
276600
Country:
China
Status:
Recruiting
Contact:
Last name:
Benkang Shi
Phone:
bkang68@sdu.edu.cn
Email:
bkang68@sdu.edu.cn
Start date:
March 1, 2023
Completion date:
December 1, 2026
Lead sponsor:
Agency:
Qilu Hospital of Shandong University
Agency class:
Other
Source:
Qilu Hospital of Shandong University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05713578
