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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06177015
Other study ID # 2023-SR-662
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date December 11, 2023
Est. completion date December 31, 2027

Study information

Verified date December 2023
Source The First Affiliated Hospital with Nanjing Medical University
Contact Shangqian Wang
Phone +862568303186
Email wsq5501@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Patients will firstly receive 6 months of darolutamide in combination with docetaxel and ADT treatment. 1. When the patient reaches: 1. PSA ≤ 0.2ng/ml 2. Or PSA > 0.2ng/ml but with more that 90% decrease comparing baseline 3. Without newly discovered metastatic lesions. They will be randomly assigned in a 1:1 ratio to either continuous treatment group or intermittent treatment group (1) Continuous treatment group: Darolutamide: 600mg, bid+ADT: Leuprorelin (3.6mg qm or 10.8mg q3m) or goserelin 80mg qm until mCRPC; (2) Intermittent treatment group: Only ADT as background treatment without Darolutamide. PSA check every three months, when the patient's PSA > 1ng/ml (or PSA > 1ng/ml and PSA has risen by more than 20% comparing baseline), restart the darolutamide, until mCRPC. 2. When the patient: 1. PSA > 0.2ng/ml and has not decreased by 90% compared to baseline 2. Or has new metastatic lesions, they will exit the study. Imaging assessment will be conducted every 3 months


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date December 31, 2027
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender Male
Age group 40 Years to 80 Years
Eligibility Inclusion Criteria: Patients must meet all of the following criteria to be eligible for this study: 1. Male aged =18 years; 2. Histologically or cytologically confirmed prostate adenocarcinoma; 3. Metastatic disease (confirmed by conventional imaging); 4. ECOG performance status of 0-1; 5. Suitable for ADT and docetaxel treatment; 6. Good bone marrow, kidney, and liver function: 1. (1) Hematological examination (no blood transfusion or use of hematopoietic growth factors within 7 days before screening): 1. 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): 1. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 2.5 × ULN 2. Total bilirubin (TBIL) = 2.0 × ULN; 3. Serum creatinine (Cr) = 2.0×ULN; 7. Willing to participate in this study, sign an informed consent form, and have good compliance Exclusion Criteria: 1. No metastatic disease; 2. 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 3. Received radiotherapy within 2 weeks before starting 6 months of darolutamide + docetaxel + ADT treatment; 4. Stroke, myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass surgery, congestive heart failure (New York Heart Association class III or IV); 5. History of malignant tumors; 6. Planned receipt of other anti-tumor treatment during the study treatment period; 7. Known allergy to the above drug components; 8. Difficulty swallowing, chronic diarrhea, intestinal obstruction, and various factors affecting drug intake and absorption; 9. Refusal to sign the informed consent form; 10. Investigator's opinion that the participant is not suitable for inclusion.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Darolutamide continuous
standard of care
Darolutamide intermittent
experimental group

Locations

Country Name City State
China Urology dpt, First Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Radiographic Progression Free Survival rPFS 36 months
Primary Overall Survival OS 36 months
Secondary Time to castration-resistant prostate cancer Time to mCRPC 36 months
Secondary Time to pain progression TTPP through study completion, an average of 3 year
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