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New treatment option for Prostate Cancer
Official title A Phase II Neoadjuvant Study of Darolutamide Plus ADT in Men With Localized Prostate Cancer
ClinicalTrials.gov ID: NCT06029036
What this study is testing
What is Darolutamide+ADT?
Darolutamide+ADT is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for prostate cancer.
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
- Scientific Rationale: High risk localized prostate cancer (PCa) is associated with higher rates of biochemical recurrence, clinical recurrence, metastasis and PCa-specific death. Novel hormone therapies(NHT) have shown a significant survival advantage with respect to classical ADT in later stages of PCa and have already been investigated in neoadjuvant setting.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, men only
You may be able to join if
- Male ≥18 years of age.
- Able to Sign informed consent form independently.
- Non-metastatic adenocarcinoma of the prostate.
- people must have as least one of the following features according to NCCN definition of high-risk: Gleason score ≥8, or PSA \>20ng/ml,or≥clinical T3a.
- people with pelvic lymph node involvement(N1) can be included.
You likely can't join if
- Prostate cancer with neuroendocrine differentiation or small cell features
- Distant metastasis based on conventional imaging (clinical stage M1). Nodal disease below the iliac bifurcation (clinical stage N1) is not an...
- History of prior systemic or local therapy for prostate cancer, including pelvic radiation for prostate cancer.
- people who are planning bilateral orchidectomy during the treatment period of the study.
- Intolerable with darolutamide or ADT treatment.
- Candidates of other clinical trials.
See the full eligibility criteria
- Male ≥18 years of age.
- Able to Sign informed consent form independently.
- Non-metastatic adenocarcinoma of the prostate.
- people must have as least one of the following features according to NCCN definition of high-risk: Gleason score ≥8, or PSA \>20ng/ml,or≥clinical T3a.
- people with pelvic lymph node involvement(N1) can be included.
- Candidate for radical prostatectomy with or without pelvic lymph node dissection as per the investigator.
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
- people must have normal organ and marrow function as defined below: Hemoglobin ≥ 9.0 g/dL;Absolute neutrophil count (ANC) ≥ 1,500/mcL; Platelets ≥ 100,000/mcL, independent of transfusions/growth factors within 3 months...
- Prostate cancer with neuroendocrine differentiation or small cell features
- Distant metastasis based on conventional imaging (clinical stage M1). Nodal disease below the iliac bifurcation (clinical stage N1) is not an exclusion.
- History of prior systemic or local therapy for prostate cancer, including pelvic radiation for prostate cancer.
- people who are planning bilateral orchidectomy during the treatment period of the study.
- Intolerable with darolutamide or ADT treatment.
- Candidates of other clinical trials.
- Any prior malignancy within 5 years.
- Complications include significant cardiovascular disease, active infection, astrointestinal disorders, or any other complications that in the opinion of the investigator.
- Any condition that in the opinion of the investigator would preclude participation in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, 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, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, 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.