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 (Jun 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
Treatments studied
Other
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)
Demographics
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.
Frequently asked questions
Is NCT06029036 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 LOCALIZED 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