Actively Recruiting

Phase 2
Age: 18Years - 75Years
MALE
NCT06575257

Neoadjuvant Therapy of Darolutamide Plus ADT for High Risk Prostate Cancer

Led by Xijing Hospital · Updated on 2024-08-28

80

Participants Needed

1

Research Sites

260 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Neoadjuvant Therapy of Darolutamide Plus ADT for High Risk Prostate Cancer

Who Can Participate

Age: 18Years - 75Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients must be 18 to 75 years old.
  • Histologically or cytologically confirmed prostate cancer eligible for radical prostatectomy.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
  • Completion of multiparametric MRI or 68Ga-PSMA PET/CT before and after neoadjuvant treatment.
  • Tumor staging showing clinical stage cT2c or cN+ or locally advanced, or Gleason score 8, or PSA 20 ng/ml.
  • Adequate organ function within 28 days before registration: WBC 4.0 109/L, platelets 100 109/L, hemoglobin 9 g/dL, INR < 1.5, total bilirubin 1.5 x ULN, AST and ALT 2.5 x ULN, serum creatinine 2 x ULN.
  • Willing to voluntarily participate and sign informed consent, understanding study purpose and procedures.
  • Willing to follow study restrictions and prohibitions.
Not Eligible

You will not qualify if you...

  • Clinical or radiological evidence of regional or distant lymph node, bone, or visceral metastases.
  • Prior androgen deprivation therapy (medical or surgical), focal prostate cancer treatment, radiotherapy, or chemotherapy.
  • Severe or uncontrolled infections.
  • New York Heart Association Class III or IV congestive heart failure.
  • Uncontrolled severe hypertension, persistent uncontrolled diabetes, oxygen-dependent lung disease, chronic liver disease, or HIV infection.
  • Mental illness, mental disability, or inability to give informed consent.
  • Other malignancies within past 5 years except cured basal cell or squamous cell skin cancers.

AI-Screening

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Trial Site Locations

Total: 1 location

1

The First Affillated Hospital, the Air Force Medical University

Xi’an, Shanxi, China, 710032

Actively Recruiting

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Research Team

W

Weijun Qin, MD

CONTACT

J

Jingliang Zhang, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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