Actively Recruiting
Intermittent Darolutamide Treatment in the Triple Therapy of mHSPC
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2023-12-26
200
Participants Needed
1
Research Sites
211 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the efficacy and safety of intermittent use of darolutamide compared to long-term use in combination with ADT and docetaxel in the treatment of mHSPC patients.
CONDITIONS
Official Title
Intermittent Darolutamide Treatment in the Triple Therapy of mHSPC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male aged 18 years or older
- Histologically or cytologically confirmed prostate adenocarcinoma
- Presence of metastatic disease confirmed by imaging
- ECOG performance status of 0 or 1
- Suitable for androgen deprivation therapy and docetaxel treatment
- Adequate bone marrow function: hemoglobin 60 g/L or above, neutrophils 1.5�d7109/L or above, platelets 80�d7109/L or above
- Adequate liver function: ALT and AST no more than 2.5 times the upper limit of normal, total bilirubin no more than 2 times the upper limit
- Adequate kidney function: serum creatinine no more than 2 times the upper limit of normal
- Willingness to participate, sign informed consent, and comply with study requirements
You will not qualify if you...
- No metastatic disease
- Prior treatment with second-generation androgen receptor inhibitors or experimental ARis
- Prior use of CYP17 enzyme inhibitors such as abiraterone acetate or oral ketoconazole for prostate cancer
- Chemotherapy or immunotherapy before randomization for prostate cancer
- Radiotherapy within 2 weeks before starting study treatment
- History of stroke, myocardial infarction, severe or unstable angina, bypass surgery, or severe heart failure (NYHA class III or IV)
- History of other malignant tumors
- Planned receipt of other anti-tumor treatments during the study
- Known allergy to study drug components
- Conditions affecting drug intake or absorption, such as difficulty swallowing, chronic diarrhea, or intestinal obstruction
- Refusal to sign informed consent
- Investigator judgment deeming patient unsuitable for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Urology dpt, First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210029
Actively Recruiting
Research Team
S
Shangqian Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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