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| Name | Class |
|---|---|
| The Affiliated Hospital of Xuzhou Medical University | OTHER |
| The First People's Hospital of Changzhou | OTHER |
| The First Affiliated Hospital of Soochow University | OTHER |
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This randomized, controlled, multi-center clinical trial aims to evaluate the efficacy and safety of prostatectomy for castration-Naive oligometastatic prostate cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADT plus abiraterone + surgery | Experimental | After 6 cycles of first-line treatment (Androgen deprivation therapy + abiraterone acetate along with prednisone) , patients will receive robot assisted laparoscopic prostatectomy + enlarged pelvic lymph node dissection (ePLND) within 9 months of being diagnosed. The ADT+abiraterone treatment will be maintained after surgery. |
|
| ADT plus abiraterone | Active Comparator | Patients will be only treated with Androgen deprivation therapy + abiraterone acetate along with prednisone. Prostatectomy won't be performed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| robot assisted laparoscopic prostatectomy + enlarged pelvic lymph node dissection | Procedure | Robot assisted laparoscopic prostatectomy + enlarged pelvic lymph node dissection will be performed. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to PSA progression progression | PSA progression is defined as elevated PSA levels(≥2ng/ml) for no less than 2 measurements at least 1 week apart. | up to 2 years |
| Time to Radiographic progression | Radiographic progression is defined as newly discovered soft tissue metastasis according to the RECIST 1.1 or at least 2 bone lesions. | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| rPFS (radiographic progression free survival) | The time of radiographic progression free survival | up to 2 years |
| Time to castration resistance | The time to castration resistance |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hongqian Guo, MD | Nanjing Drum Tower Hospital, affiliated to medical school of Nanjing University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Nanjing | Jiangsu | China |
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| Wuxi People's Hospital |
| OTHER |
| Affiliated Hospital of Nantong University | OTHER |
| Yangzhou University | OTHER |
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| 1.Abiraterone Acetate Tablets | Drug | 1000mg(4 tablets, 250mg per tablet) daily for 6 cycles |
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| Prednisone Acetate Tablets | Drug | 5 mg oral low dose prednisone taken along with Abiraterone Acetate Tablets |
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| Luteinizing Hormone-Releasing Hormone Analog | Drug | Hypodermic injection of Luteinizing Hormone-Releasing Hormone Analog every 4 weeks including goserelin, leuprolide, triptorelin ect. |
|
| up to 2 years |
| Time to PSA remission (≥50%) and time to PSA remission (≥90%) | Time to the point when PSA drop to below 50% initial PSA level. Time to the point when PSA drop to below 10% initial PSA level. | up to 2 years |
| Time to new anti-cancer treatment | Time to the point when onther anti-cancer treatment is necessary | up to 2 years |
| ID | Term |
|---|---|
| D011241 | Prednisone |
| D007987 | Gonadotropin-Releasing Hormone |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
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