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New treatment option for Metastatic Prostate Cancer
Official title Intermittent Darolutamide Treatment in the Triple Therapy of mHSPC
ClinicalTrials.gov ID: NCT06177015
What this study is testing
What is Darolutamide continuous?
Darolutamide continuous is an investigational medicine, being studied as a potential treatment for metastatic prostate cancer.
Also referred to as Darolutamide.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 80, men only
You may be able to join if
- 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;
You likely can't join if
- No metastatic disease;
- Prior treatment with: a) Second-generation ARis or other experimental ARis b) CYP17 enzyme inhibitors such as abiraterone acetate or oral...
- Received radiotherapy within 2 weeks before starting 6 months of darolutamide + docetaxel + ADT treatment;
- Stroke, myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass surgery, congestive heart failure (New York Heart...
- History of malignant tumors;
- Planned receipt of other anti-tumor treatment during the study treatment period;
See the full eligibility criteria
- 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...
- 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
- No metastatic disease;
- 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...
- Received radiotherapy within 2 weeks before starting 6 months of darolutamide + docetaxel + ADT treatment;
- 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;
- Planned receipt of other anti-tumor treatment during the study treatment period;
- Known allergy to the above drug components;
- Difficulty swallowing, chronic diarrhea, intestinal obstruction, and various factors affecting drug intake and absorption;
- Refusal to sign the informed consent form;
- Investigator's opinion that the participant is not suitable for inclusion.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 40 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.