This randomized controlled trial was designed to evaluate the efficacy and safety of Docetaxel combined with Platinum-based drugs compared with Docetaxel alone for metastatic hormone-sensitive prostate cancer patients carrying DNA repair mutation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Docetaxel will be given intravenously 75 mg/m2 every 3 weeks for 6 cycles.
5mg Prednisolone Acetate will be given orally twice a day during treatment.
Platinum-based drugs will be given intravenously 70 mg/m2 every 3 weeks for 6 cycles. Cisplatin or carboplatin will be carefully chosen according to each patient's Creatinine Clearance.
Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University
Nanjing, Jiangsu, China
RECRUITINGTime to Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Time from treatment initiation to Metastatic Castration-Resistant Prostate Cancer (mCRPC). Patients with metastatic prostate cancer develop PCa progression during androgen deprivation therapy (or after bilateral orchiectomy), meet any of the following criteria was defined as mCRPC. 1)PSA progression (defined as elevated PSA levels(≥1ng/ml) for no less than 2 measurements at least 1 week apart); 2) Radiographic progression in soft tissues, with or without PSA progression, according to RECIST 1.1 criteria; 3) Bone progression (defined as 2 or more new bone lesions on bone scans) with or without PSA progression, according to PCWG.
Time frame: up to 3 years
Overall survival
The survival rate of participants during follow-up time.
Time frame: up to 5 years
rPFS
Radiographic progression-free survival. The survival of participants without radiographic progression.
Time frame: up to 5 years
Time to PSA progression
PSA progression is defined as elevated PSA levels(≥2ng/ml) for no less than 2 measurements at least 1 week apart.
Time frame: up to 5 years
Time to subsequent anti-tumor therapy
Time from end of treatment to the time when subsequent anti-tumor therapy is needed.
Time frame: up to 5 years
Adverse events
All grades of adverse events will be recorded according to NCI CTCAE (v.5.0)
Time frame: up to 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.