Darolutamide Plus Hormone Therapy Before Prostate Surgery for High-Risk Prostate Cancer
Tests darolutamide with hormone therapy before surgery in men with high-risk prostate cancer.
Plain-language title generated from the registry record
Registry title: Neoadjuvant Therapy of Darolutamide Plus ADT for High Risk Prostate Cancer
Key facts
- Where
- Xi’an, ChinaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06575257, who can take part
Where in China
- The First Affillated Hospital, the Air Force Medical UniversityXi’an, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Xijing Hospital
- Trial code
- NCT06575257
- Record updated
- 28 August 2024
- Original description
The purpose of this study is to determine if treatment with Darolutamide plus androgen deprivation therapy (ADT) before radical prostatectomy (RP) with pelvic lymph node dissection (pLND) in participants with high-risk localized or locally advanced prostate cancer results in an improvement in pathological complete response (pCR) rate and pathological tumor volume with minimal residual disease (MRD)) as compared to ADT.Read full original descriptionShow less
Neoadjuvant ADT +/- Darolutamide Followed by Radical Prostatectomy for High-risk Prostate Cancer: a Randomized, Open Label Trial
The purpose of this study is to determine if treatment with Darolutamide plus androgen deprivation therapy (ADT) before radical prostatectomy (RP) with pelvic lymph node dissection (pLND) in participants with high-risk localized or locally advanced prostate cancer results in an improvement in pathological complete response (pCR) rate and pathological tumor volume with minimal residual disease (MRD)) as compared to ADT.
Inclusion: Patients must be ≥ 18 and ≤75 years of age; All patients must have a histologically or cytologically diagnosis of prostate cancer and must be eligible for radical prostatectomy; Eastern Cooperative Oncology Group (ECOG) Performance Status score ≤1; All patients must complete mpMRI or 68Ga-PSMA PET / CT before and after neoadjuvant treatment; All patients must undergo thorough tumor staging and meet one of the following criteria: 1. multi-parameter MRI or PSMA PET / CT shows clinical staging of primary tumor ≥ cT2c or cN+or locally advanced, 2. Gleason score of primary tumor ≥ 8, 3. prostate specific antigen (PSA) ≥20 ng/ml; Patients must have adequate organ function as defined by the following criteria(within 28 days prior to registration):; white blood cell (WBC) ≥ 4.0 × 109 / L platelets≥ 100 × 109 / L hemoglobin ≥ 9 g / dL international normalized ratio (INR) < 1.5. total bilirubin (TBIL)≤1.5 x upper limit of normal (ULN) SGOT (AST) and SGPT (ALT) ≤ 2.5 x ULN serum creatinine ≤2×ULN; Patients must participate voluntarily and sign an informed consent form (ICF), indicating that they understand the purpose and required procedures of the study, and are willing to participate in. Patients must be willing to obey the prohibitions and restrictions specified in the research protocol.
Exclusion: Prior androgen deprivation therapy (medical or surgical) or focal treatment of prostate cancer or prostate cancer radiotherapy or prostate cancer chemotherapy; severe or uncontrolled concurrent infections; New York Heart Association Class III or IV congestive heart failure at the time of screening; uncontrolled severe hypertension, persistent uncontrolled diabetes, oxygen-dependent lung disease, chronic liver disease, or HIV infection; Patients with mental illness, mental disability or inability to give informed consent are not eligible; Patients have had other malignancies other than prostate cancer in the past 5 years, but cured basal cell or squamous cell skin cancers can be enrolled; clinical or radiological evidence of regional or extra-regional lymph node metastases or bone metastases or visceral metastases.