NCT06177015RecruitingPhase 3
Intermittent Darolutamide Treatment in the Triple Therapy of mHSPC
Randomized Controlled Study on the Efficacy and Safety of Intermittent Darolutamide Treatment in the Triple Therapy of Metastatic Hormone Sensitive Prostate Cancer
Source: ClinicalTrials.gov · Last updated 26 Dec 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 11 Dec 2023
- Start date
- Dec 2023
- Primary completion date
- Dec 2025
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Diseases
- Prostate cancer
- NCT number
- NCT06177015
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 200
- From Dec 2023 to the primary completion date, Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- 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;
Other
- 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.
Who the study is looking for
- 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\. (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):
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN
- Total bilirubin (TBIL) ≤ 2.0 × ULN;
- Serum creatinine (Cr) ≤ 2.0×ULN;
- 7\. Willing to participate in this study, sign an informed consent form, and have good compliance
Age in the registry: 40 years to 80 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Urology dpt, First Affiliated Hospital of Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.