Actively Recruiting
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
Led by Qilu Hospital of Shandong University · Updated on 2023-02-06
220
Participants Needed
1
Research Sites
195 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patients aged 18 years or older
- Diagnosed with prostate adenocarcinoma by histology or cytology
- Presence of 4 or more bone metastases with at least one outside pelvis or spine, or visceral metastasis confirmed by imaging
- Sensitive to endocrine therapy after recurrence from new or local treatment
- Receiving ADT (drug or surgical) for no more than 3 months without soft tissue progression or significant PSA increase
- Planned treatment with apantamide combined with docetaxel and ADT or apantamide combined with ADT
- ECOG performance status score of 0 to 1
- Adequate bone marrow, liver, kidney, and coagulation function as defined by specific laboratory values
You will not qualify if you...
- History of hypersensitivity or intolerance to any study drug
- Planned to receive other anti-tumor treatments during the study
- Prior use of second-generation androgen receptor inhibitors, CYP17 enzyme inhibitors, chemotherapy, immunotherapy, or adjuvant therapies
- Use of herbal drugs affecting prostate cancer or PSA levels within 4 weeks before study
- History of seizures or conditions that lower seizure threshold within 12 months before study
- Active heart disease within 6 months before treatment including severe angina, recent myocardial infarction, heart failure NYHA III/IV, or arrhythmias needing treatment
- Conditions preventing swallowing or absorption of medication
- History of immunodeficiency or organ transplantation
- Known brain metastases
- Other cancers within 5 years except certain cured skin or cervical cancers
- Receiving other experimental drugs or devices
- Poor compliance or inability to cooperate with treatment and follow-up
- Any serious concomitant diseases or conditions that may endanger safety or affect study completion as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Qilu hospital
Jinan, Shandong, China, 276600
Actively Recruiting
Research Team
B
Benkang Shi, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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