Actively Recruiting
Efficacy and Safety of Apantamide Combined With Docetaxel and ADT vs. Apantamide Combined With ADT in Patients With High Tumor Burden Metastatic Hormone-Sensitive Prostate Cancer: A Multicenter Prospective Cohort Study
Led by Qilu Hospital of Shandong University · Updated on 2023-02-06
220
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of two treatment combinations in patients with high tumor burden metastatic hormone-sensitive prostate cancer (mHSPC). This multicenter, prospective cohort study compares apantamide combined with docetaxel and androgen deprivation therapy (ADT) versus apantamide combined with ADT alone. The study includes 220 patients and aims to provide data on treatment outcomes and manage side effects under clinical supervision. Participants are divided into two groups: one receives apantamide, docetaxel, and ADT, while the other receives apantamide and ADT. Apantamide is taken orally daily at 240 mg. ADT uses gonadotropin releasing hormone analogs as per each research center's protocols. Docetaxel is given intravenously every three weeks for six cycles, starting within six weeks after beginning apantamide and ADT. Dosages are adjusted based on adverse reactions, and preventive medications may be used to reduce side effects. Treatment continues until clinical benefit is no longer observed, intolerable side effects occur, or the patient withdraws consent. During the study, patients are monitored for progression of cancer using imaging and laboratory assessments. The main outcome measured is the three-year radiographic progression-free survival rate. Secondary outcomes include time to castration-resistant prostate cancer, PSA progression time, and survival without asymptomatic skeletal events. Patients undergo regular evaluations to track safety, treatment response, and overall health. The study is expected to complete by December 2026, with ongoing monitoring throughout the treatment period.
CONDITIONS
Brief 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 to 90 years
- Diagnosed with prostate adenocarcinoma confirmed by histology or cytology
- Bone imaging, CT or MRI showing at least 4 bone metastases with at least one outside the pelvis or spine, or presence of visceral metastasis
- Patients sensitive to endocrine therapy after recurrence following new or local treatment
- Receiving androgen deprivation therapy (ADT) for no more than 3 months without evidence of disease progression or significant PSA increase
- Planned to receive either docetaxel combined with apantamide and ADT or apantamide combined with ADT
- ECOG performance status score of 0 or 1
- Adequate bone marrow, liver, kidney, and coagulation function as defined in the protocol
You will not qualify if you...
- History of hypersensitivity or intolerance to any study drugs
- Planned to receive other anti-tumor treatments during the study
- Previous treatment with second-generation androgen receptor inhibitors, CYP17 enzyme inhibitors, chemotherapy, immunotherapy, or related therapies
- Use of plant drugs with anti-prostate cancer effects within 4 weeks before study start
- History of epileptic seizures or related neurological conditions within 12 months before study
- Active heart disease within 6 months before study treatment
- Conditions affecting drug administration or absorption such as inability to swallow or intestinal obstruction
- History of immunodeficiency or organ transplantation
- Known brain metastasis
- Other malignant tumors within past 5 years except certain cured cancers
- Participation in other experimental drug or medical device studies
- Poor compliance or inability to cooperate with treatment and follow-up
- Concomitant diseases that may risk safety or affect study completion as judged by investigator
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until clinical benefit ends, intolerable toxicity, or withdrawal
Participants receive treatment with apantamide and ADT, with some participants also receiving docetaxel. Docetaxel is given intravenously every 3 weeks for 6 cycles, starting within 6 weeks after beginning apantamide and ADT. Apantamide is taken daily by mouth, and ADT dosing and frequency are determined by the investigator. Treatment continues until clinical benefit ends, intolerable side effects occur, or withdrawal.
Docetaxel infusions every 3 weeks for 6 cycles; daily oral apantamide; ADT as determined by investigators
Trial Site Locations
Total: 1 location
1
Qilu hospital
Jinan, Shandong, China, 276600
Actively Recruiting
Research Team
B
Benkang Shi, Dr.
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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