Combining Darolutamide with hormone therapy for high-risk prostate cancer before surgery
Neoadjuvant ADT +/- Darolutamide Followed by Radical Prostatectomy for High-risk Prostate Cancer: a Randomized, Open Label Trial
This study is testing if adding Darolutamide to hormone therapy helps men with high-risk prostate cancer shrink their tumors more effectively before surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Male |
| Sponsor | Xijing Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Xi’an, Shanxi) |
| Trial ID | NCT06575257 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of Darolutamide combined with androgen deprivation therapy (ADT) as a neoadjuvant treatment for patients with high-risk localized or locally advanced prostate cancer prior to radical prostatectomy. The goal is to assess whether this combination improves the rate of pathological complete response and reduces pathological tumor volume with minimal residual disease compared to ADT alone. Participants will undergo imaging studies before and after treatment to evaluate the outcomes.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 to 75 with high-risk localized or locally advanced prostate cancer who are eligible for radical prostatectomy.
Not a fit: Patients with low-risk prostate cancer or those who are not candidates for surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment approach could lead to better surgical outcomes and lower recurrence rates for patients with high-risk prostate cancer.
How similar studies have performed: Other studies have shown promising results with similar neoadjuvant therapies in prostate cancer, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients must be ≥ 18 and ≤75 years of age. * All patients must have a histologically or cytologically diagnosis of prostate cancer and must be eligible for radical prostatectomy. * Eastern Cooperative Oncology Group (ECOG) Performance Status score ≤1. * All patients must complete mpMRI or 68Ga-PSMA PET / CT before and after neoadjuvant treatment. * All patients must undergo thorough tumor staging and meet one of the following criteria: 1. multi-parameter MRI or PSMA PET / CT shows clinical staging of primary tumor ≥ cT2c or cN+or locally advanced, 2. Gleason score of primary tumor ≥ 8, 3. prostate specific antigen (PSA) ≥20 ng/ml. * Patients must have adequate organ function as defined by the following criteria(within 28 days prior to registration): white blood cell (WBC) ≥ 4.0 × 109 / L platelets≥ 100 × 109 / 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 * Patients must participate voluntarily and sign an informed consent form (ICF), indicating that they understand the purpose and required procedures of the study, and are willing to participate in. Patients must be willing to obey the prohibitions and restrictions specified in the research protocol. Exclusion Criteria: * clinical or radiological evidence of regional or extra-regional lymph node metastases or bone metastases or visceral metastases. * Prior androgen deprivation therapy (medical or surgical) or focal treatment of prostate cancer or prostate cancer radiotherapy or prostate cancer chemotherapy. * severe or uncontrolled concurrent infections. * New York Heart Association Class III or IV congestive heart failure at the time of screening. * uncontrolled severe hypertension, persistent uncontrolled diabetes, oxygen-dependent lung disease, chronic liver disease, or HIV infection. * Patients with mental illness, mental disability or inability to give informed consent are not eligible. * Patients have had other malignancies other than prostate cancer in the past 5 years, but cured basal cell or squamous cell skin cancers can be enrolled.
Where this trial is running
Xi’an, Shanxi
- The First Affillated Hospital, the Air Force Medical University — Xi’an, Shanxi, China (Recruiting)
Study contacts
- Principal investigator: Weijun Qin, MD — The First Affillated Hospital, the Air Force Medical University
- Study coordinator: Weijun Qin, MD
- Email: qinwj@fmmu.edu.cn
- Phone: 029-84771579
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.