Tests intermittent darolutamide with hormone therapy and docetaxel for prostate cancer
Compares stopping and restarting darolutamide with continuous use in men with advanced prostate cancer.
Plain-language title generated from the registry record
Registry title: Intermittent Darolutamide Treatment in the Triple Therapy of mHSPC
Key facts
- Where
- Nanjing, ChinaSee the site
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 80 years old?
Source: NCT06177015, who can take part
Where in China
- Urology dpt, First Affiliated Hospital of Nanjing Medical UniversityNanjing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The First Affiliated Hospital with Nanjing Medical University
- Trial code
- NCT06177015
- Record updated
- 26 December 2023
- Original description
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.Read full original descriptionShow less
Randomized Controlled Study on the Efficacy and Safety of Intermittent Darolutamide Treatment in the Triple Therapy of Metastatic Hormone Sensitive Prostate Cancer
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.
Inclusion: Patients must meet all of the following criteria to be eligible for this study:; Male aged ≥18 years; Histologically or cytologically confirmed prostate adenocarcinoma; Metastatic disease (confirmed by conventional imaging); ECOG performance status of 0-1; Suitable for ADT and docetaxel treatment; Good bone marrow, kidney, and liver function:; (1) Hematological examination (no blood transfusion or use of hematopoietic growth factors within 7 days before screening):; Hemoglobin (HB) ≥ 90g/L; 2. Absolute neutrophil count (ANC) ≥ 1.5×109/L; 3. Platelets (PLT) ≥ 80×109/L; 2. (2) Blood biochemistry examination (no blood transfusion or albumin within 7 days before screening):; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; Total bilirubin (TBIL) ≤ 2.0 × ULN; Serum creatinine (Cr) ≤ 2.0×ULN; Willing to participate in this study, sign an informed consent form, and have good compliance.
Exclusion: Prior treatment with: a) Second-generation ARis or other experimental ARis b) CYP17 enzyme inhibitors such as abiraterone acetate or oral ketoconazole for anti-tumor treatment of prostate cancer c) Chemotherapy or immunotherapy prior to randomization for prostate cancer; Received radiotherapy within 2 weeks before starting 6 months of darolutamide + docetaxel + ADT treatment; Difficulty swallowing, chronic diarrhea, intestinal obstruction, and various factors affecting drug intake and absorption; No metastatic disease; Stroke, myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass surgery, congestive heart failure (New York Heart Association class III or IV); History of malignant tumors; Known allergy to the above drug components; Planned receipt of other anti-tumor treatment during the study treatment period; Refusal to sign the informed consent form; Investigator's opinion that the participant is not suitable for inclusion.