To hear about similar clinical trials, please enter your email below
Trial Title:
Neoadjuvant Therapy of Darolutamide Plus ADT for High Risk Prostate Cancer
NCT ID:
NCT06575257
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Goserelin
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Darolutamide
Description:
600 mg orally twice daily for 12 weeks before radical prostatectomy
Arm group label:
Darolutamide Plus ADT
Intervention type:
Drug
Intervention name:
Goserelin 3.6 mg
Description:
3.6 mg goserelin hypodermic once per 4 weeks
Arm group label:
ADT alone
Arm group label:
Darolutamide Plus ADT
Summary:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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 Criteria:
- clinical or radiological evidence of regional or extra-regional lymph node
metastases or bone metastases or visceral metastases.
- 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.
Gender:
Male
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affillated Hospital, the Air Force Medical University
Address:
City:
Xi'an
Zip:
710032
Country:
China
Status:
Recruiting
Start date:
May 1, 2024
Completion date:
May 2029
Lead sponsor:
Agency:
Xijing Hospital
Agency class:
Other
Source:
Xijing Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06575257
