Clinical trial NCT06575257: Neoadjuvant Therapy of Darolutamide Plus ADT for High Risk Prostate Cancer
Official title: Neoadjuvant ADT +/- Darolutamide Followed by Radical Prostatectomy for High-risk Prostate Cancer: a Randomized, Open Label Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2024-08-28
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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.

Primary outcomes:
measure: Pathologic Complete Response Rate
timeFrame: After 12 weeks of neoadjuvant therapy + RP + PLND
measure: Proportion of Subjects With Minimal Residual Disease
timeFrame: After 12 weeks of neoadjuvant therapy + RP + PLND
Secondary outcomes:
measure: Rate of Stage Degradation
timeFrame: After 12 weeks of neoadjuvant therapy + RP + PLND
measure: Rate of Positive Surgical Margins
timeFrame: After 12 weeks of neoadjuvant therapy + RP + PLND
measure: Rate of Complete Serum Remission
timeFrame: After 12 weeks of neoadjuvant therapy
measure: Proportion of subjects without PSA progression
timeFrame: 2 years after RP
measure: Imaging Response Rate
timeFrame: After 12 weeks of neoadjuvant therapy
measure: Recovery time of urinary continence (day)
timeFrame: 1 years after RP
measure: biochemical recurrence-free survival (bRFS)
timeFrame: 3 years after RP
measure: metastasis-free survival (MFS)
timeFrame: 5 years after RP
Other outcomes:
Locations:
city: Xi'an
country: China
facility: The First Affillated Hospital, the Air Force Medical University
state: Shanxi
Study officials:
affiliation: The First Affillated Hospital, the Air Force Medical University
name: Weijun Qin, MD
role: PRINCIPAL_INVESTIGATOR
References: