Neoadjuvant Therapy of Darolutamide Plus ADT for High Risk Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Darolutamide, Goserelin 3.6 mg.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: 18 years — 75 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Neoadjuvant ADT +/- Darolutamide Followed by Radical Prostatectomy for High-risk Prostate Cancer: a Randomized, Open Label Trial
Overview
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.
Interventions
- Drug Darolutamide
600 mg orally twice daily for 12 weeks before radical prostatectomy - Drug Goserelin 3.6 mg
3.6 mg goserelin hypodermic once per 4 weeks
Primary outcome measures
- Pathologic Complete Response Rate [Time frame: After 12 weeks of neoadjuvant therapy + RP + PLND]
- Proportion of Subjects With Minimal Residual Disease [Time frame: After 12 weeks of neoadjuvant therapy + RP + PLND]
Secondary outcome measures (8)
- Rate of Stage Degradation [Time frame: After 12 weeks of neoadjuvant therapy + RP + PLND]
- Rate of Positive Surgical Margins [Time frame: After 12 weeks of neoadjuvant therapy + RP + PLND]
- Rate of Complete Serum Remission [Time frame: After 12 weeks of neoadjuvant therapy]
- Proportion of subjects without PSA progression [Time frame: 2 years after RP]
- Imaging Response Rate [Time frame: After 12 weeks of neoadjuvant therapy]
- Recovery time of urinary continence (day) [Time frame: 1 years after RP]
- biochemical recurrence-free survival (bRFS) [Time frame: 3 years after RP]
- metastasis-free survival (MFS) [Time frame: 5 years after RP]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- The First Affillated Hospital, the Air Force Medical University — Xi’an
Identifiers
NCT: NCT06575257 · KY20242118-C-1