NCT06029036 A Phase II Neoadjuvant Study of Darolutamide Plus ADT in Men With Localized Prostate Cancer
| NCT ID | NCT06029036 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Peking University First Hospital |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 53 participants |
| Start Date | 2023-08-05 |
| Primary Completion | 2025-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 53 participants in total. It began in 2023-08-05 with a primary completion date of 2025-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Male ≥18 years of age. 2. Able to Sign informed consent form independently. 3. Non-metastatic adenocarcinoma of the prostate. 4. Subjects must have as least one of the following features according to NCCN definition of high-risk: Gleason score ≥8, or PSA \>20ng/ml,or≥clinical T3a. 5. Subjects with pelvic lymph node involvement(N1) can be included. 6. Candidate for radical prostatectomy with or without pelvic lymph node dissection as per the investigator. 7. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1. 8. Subjects must have normal organ and marrow function as defined below: Hemoglobin ≥ 9.0 g/dL;Absolute neutrophil count (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 upper limit of normal (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);Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x ULN;Serum albumin ≥ 3.0 g/dL;Serum creatinine \< 2.0 x ULN. Exclusion Criteria: 1. Prostate cancer with neuroendocrine differentiation or small cell features 2. Distant metastasis based on conventional imaging (clinical stage M1). Nodal disease below the iliac bifurcation (clinical stage N1) is not an exclusion. 3. History of prior systemic or local therapy for prostate cancer, including pelvic radiation for prostate cancer. 4. Subjects who are planning bilateral orchidectomy during the treatment period of the study. 5. Intolerable with darolutamide or ADT treatment. 6. Candidates of other clinical trials. 7. Any prior malignancy within 5 years. 8. Complications include significant cardiovascular disease, active infection, astrointestinal disorders, or any other complications that in the opinion of the investigator. 9. Any condition that in the opinion of the investigator would preclude participation in this study.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06029036 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 75 Years, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06029036 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06029036 currently recruiting?
Yes, NCT06029036 is actively recruiting participants. Contact the research team at wyj7074@sohu.com for enrollment information.
Where is the NCT06029036 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06029036 clinical trial?
NCT06029036 is sponsored by Peking University First Hospital. The trial plans to enroll 53 participants.
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