OncoMatch/Clinical Trials/NCT06029036
A Phase II Neoadjuvant Study of Darolutamide Plus ADT in Men With Localized Prostate Cancer
Is NCT06029036 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Darolutamide+ADT for prostate cancer.
Treatment: Darolutamide+ADT — Scientific Rationale: High risk localized prostate cancer (PCa) is associated with higher rates of biochemical recurrence, clinical recurrence, metastasis and PCa-specific death. Novel hormone therapies(NHT) have shown a significant survival advantage with respect to classical ADT in later stages of PCa and have already been investigated in neoadjuvant setting. PURPOSE: To assess antitumor effect by measuring pathological tumor volume with pathological downstaging following radical prostatectomy + pelvic lymph-node dissection (RP + PLND) for high-risk localized prostate cancer patients.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Disease stage
Required: Stage LOCALIZED (NCCN)
Non-metastatic adenocarcinoma of the prostate. Subjects with pelvic lymph node involvement(N1) can be included. Distant metastasis based on conventional imaging (clinical stage M1) [excluded].
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic or local therapy for prostate cancer
History of prior systemic or local therapy for prostate cancer, including pelvic radiation for prostate cancer
Lab requirements
Blood counts
Hemoglobin ≥ 9.0 g/dL; ANC ≥ 1,500/mcL; Platelets ≥ 100,000/mcL, independent of transfusions/growth factors within 3 months of treatment start
Kidney function
Serum creatinine < 2.0 x ULN; Serum potassium ≥ 3.5 mmol/L
Liver function
Serum total bilirubin ≤ 2.0 x ULN (except in subjects with Gilbert's syndrome who have a total bilirubin > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤ 1.5 x ULN, subject may be eligible); AST, ALT ≤ 2.5 x ULN; Serum albumin ≥ 3.0 g/dL
Subjects must have normal organ and marrow function as defined below: Hemoglobin ≥ 9.0 g/dL; ANC ≥ 1,500/mcL; Platelets ≥ 100,000/mcL, independent of transfusions/growth factors within 3 months of treatment start; Serum potassium ≥ 3.5 mmol/L; Serum total bilirubin ≤ 2.0 x ULN (except in subjects with Gilbert's syndrome who have a total bilirubin > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤ 1.5 x ULN, subject may be eligible); AST, ALT ≤ 2.5 x ULN; Serum albumin ≥ 3.0 g/dL; Serum creatinine < 2.0 x ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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