Intermittent treatment with darolutamide for metastatic prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the efficacy and safety of intermittent darolutamide treatment compared to continuous use in combination with androgen deprivation therapy (ADT) and docetaxel for patients with metastatic hormone-sensitive prostate cancer (mHSPC). Initially, participants will receive darolutamide alongside ADT and docetaxel for six months. Following this, patients who achieve specific prostate-specific antigen (PSA) criteria will be randomly assigned to either a continuous treatment group or an intermittent treatment group, with regular monitoring of PSA levels and imaging assessments. The goal is to determine the optimal treatment approach for managing mHSPC.

Why it matters

Who can join: the full rules

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.

Where it's running

• Urology dpt, First Affiliated Hospital of Nanjing Medical University
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Principal investigator: Lixxin Hua — Urology Dpt, First Affiliated Hospital of Nanjing Medical University
• Study coordinator: Shangqian Wang
• Email: wsq5501@126.com
• Phone: +862568303186

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.