Intermittent treatment with darolutamide for metastatic prostate cancer

Randomized Controlled Study on the Efficacy and Safety of Intermittent Darolutamide Treatment in the Triple Therapy of Metastatic Hormone Sensitive Prostate Cancer

This study is testing if taking darolutamide in cycles, instead of all the time, can help men with advanced prostate cancer feel better while using other treatments.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 40 Years to 80 Years
• Sex: Male
• Sponsor: The First Affiliated Hospital with Nanjing Medical University (Academic / other)
• Drugs / interventions: Chemotherapy, immunotherapy
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06177015 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include males aged 18 and older with histologically confirmed metastatic prostate adenocarcinoma and suitable for ADT and docetaxel treatment.

Not a fit: Patients with new metastatic lesions or those whose PSA levels do not meet the specified criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a more effective and potentially less burdensome treatment option for patients with metastatic prostate cancer.

How similar studies have performed: While there have been studies on continuous and intermittent anti-androgen therapies, the specific approach of intermittent darolutamide in this context is relatively novel.

Eligibility criteria

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 this trial is running

Nanjing, Jiangsu

• 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

Conditions Metastatic Prostate Cancer; Intermitent Anti-androgen Therapy; triple treatment regimen; mHPSC; Darolutemide