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| Name | Class |
|---|---|
| The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | OTHER |
| The First Affiliated Hospital of Air Force Medicial University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Darolutamide + ADT | Experimental | Duration of treatment: 28-day cycle of darolutamide treatment and 6 cycles of neoadjuvant therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Darolutamide+ADT | Drug | Drug: Darolutamide Darolutamide 600 mg, (two 300 mg tablets) administered orally twice daily. Swallow tablets whole. Take Darolutamide with food. Drug: ADT GnRH agonist per physicians' choice, orchiectomy is excluded |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of pathological downstaging | Percentage of patients with tumor downstaging | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| pCR or MRD | Pathologic complete response or Minimal Residual Disease(defined as overall diameter <5 mm) | 6 months |
| PSM | Percentage of patients with positive surgical margins |
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Inclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhisong He, MD | Contact | +8610-83572418 | wyj7074@sohu.com | |
| Kaiwei Yang, MD | Contact | 13811501435 | 13811501435@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 6 months |
| Rate of peri-operative complications | including delay in surgery, intra-operative complications, and postoperative complications | within 30 days of surgery |
| Biochemical complete response | PSA <0.1ng/ml prior to RP | 6 months |
| PSA undetectable rate | PSA<0.02 ng/ml | 12 months post-RP |
| 2-year biochemical progression-free survival, bPFS | PSA>0.2 ng/ml | 24 months post-RP |
| AEs/SAEs | The level of AEs defined by NCI-CTCAE v5.0. Safety assessments will be assessed and documented after initiation of study drug, regardless of relationship to study drug. | Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |