OncoMatch/Clinical Trials/NCT06575257
Neoadjuvant Therapy of Darolutamide Plus ADT for High Risk Prostate Cancer
Is NCT06575257 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Darolutamide and Goserelin 3.6 mg for prostate cancer.
Treatment: Darolutamide · Goserelin 3.6 mg — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Endocrine / hormonal
Other
Cancer type
Prostate Cancer
Disease stage
Required: Stage CT2C OR HIGHER, CN+, III (clinical (mpMRI or PSMA PET/CT))
Grade: Gleason score ≥ 8 (Gleason)
clinical staging of primary tumor ≥ cT2c or cN+ or locally advanced, Gleason score of primary tumor ≥ 8, PSA ≥20 ng/ml
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: androgen deprivation therapy
Prior androgen deprivation therapy (medical or surgical)
Cannot have received: focal treatment of prostate cancer
focal treatment of prostate cancer
Cannot have received: radiation therapy
prostate cancer radiotherapy
Cannot have received: cytotoxic chemotherapy
prostate cancer chemotherapy
Lab requirements
Blood counts
WBC ≥ 4.0 × 10^9 / L; platelets ≥ 100 × 10^9 / L; hemoglobin ≥ 9 g / dL; INR < 1.5
Kidney function
serum creatinine ≤2×ULN
Liver function
total bilirubin (TBIL) ≤1.5 x ULN; SGOT (AST) and SGPT (ALT) ≤ 2.5 x ULN
WBC ≥ 4.0 × 10^9 / L platelets≥ 100 × 10^9 / 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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06575257 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
What disease stage is eligible?
Stage CT2C OR HIGHER or CN+ or III is required.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Is this trial open to female patients?
No. This trial enrolls male patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages