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This is a prospective, multicenter, multi-arm, non-randomized, open-label clinical trial to evaluate the efficacy and safety of neoadjuvant intense endocrine therapy for high-risk or locally advanced prostate cancer.
The study was designed to evaluate the efficacy and safety of different forms of neoadjuvant intense androgen deprivation therapy (ADT) compared with ADT alone, followed by prostatectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADT alone + prostatectomy | Active Comparator | A total of 100 subjects receive ADT for 6 cycles (28 days per cycle) before prostatectomy. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy. |
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| ADT plus Abiraterone | Experimental | A total of 150 subjects in this group received abiraterone acetate + prednisolone acetate daily for 6 cycles along with ADT. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy. |
|
| ADT plus Enzalutamide | Experimental | A total of 50 subjects in this group received enzalutamide daily for 6 cycles along with ADT. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy. |
|
| ADT plus Apalutamide | Experimental | A total of 150 subjects in this group received apalutamide daily for 6 cycles along with ADT. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADT | Drug | The ADT regimen will be determined by the investigators at separate centers. The dose and frequency of administration will be consistent with the prescribing information. Available drugs include triptorelin, goserelin, leuprolide, digareke ect. |
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic response rate | Pathologic response rate= Pathologic Complete Response (pCR) Rate + Minimal Residual Disease (MRD) rate | up to 3 years |
| 3 year biochemical progression free survival (bPFS) | Biochemical progression free survival (bPFS) within 3 years | up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Metastasis-Free Survival (MFS) | Metastasis-Free Survival (MFS) after intense neoadjuvant therapy | up to 5 years |
| Time to castration-resistant prostate cancer(CRPC) | Time to castration-resistant prostate cancer(CRPC) after intense neoadjuvant therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University | Recruiting | Nanjing | Jiangsu | 210000 | China |
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| ADT plus Darotamide | Experimental | A total of 150 subjects in this group received darotamide daily for 6 cycles along with ADT. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy. |
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| ADT plus Rizvilutamide | Experimental | A total of 150 subjects in this group received rizvilutamide daily for 6 cycles along with ADT. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy. |
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| PARP inhibitor + abiraterone + ADT | Experimental | A total of 100 subjects in this group received Poly ADP-ribose Polymerase (PARP) Inhibitor plus abiraterone along with ADT. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy. |
|
| PARP inhibitor + ADT | Experimental | A total of 50 subjects in this group in this group received Poly ADP-ribose Polymerase (PARP) Inhibitor along with ADT mentioned above. Enrolled patients carry homologous recombination repair (HRR) gene mutation verified by molecular testing. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy. |
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| Abiraterone Acetate | Drug | 1000 mg (250 mg×4 tablets) once daily, orally |
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| Prednisolone tablets | Drug | 5 mg once daily, orally. |
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| Enzalutamide | Drug | 160 mg (40 mg× 4 tablets) once daily, orally. |
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| Apalutamide | Drug | 240 mg (60 mg×4 tablets) once daily, orally. |
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| Darotamide | Drug | 600 mg (300 mg × 2 tablets) twice daily, orally. |
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| Rezvilutamide | Drug | 240 mg (80 mg × 3 tablets) once daily orally |
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| PARP inhibitor | Drug | The PARP inhibitors will be determined by the investigators at separate centers. The dosage and frequency of administration will be consistent with the prescribing information. Available drugs include olaparib, fluzoparib, pamiparib, talazoparib ect. |
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| Robot-assisted radical prostatectomy | Procedure | Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy. |
|
| up to 5 years |
| PSA response rate | Prostate specific antigen (PSA) drops ≥ 98% after intense neoadjuvant therapy | up to 3 years |
| Positive margin rate | The positive margin rate of whole-mount pathology for prostatectomy after intense neoadjuvant therapy | up to 6 months |
| Pathologic downgrade rate | The pathologic downgrade rate of whole-mount pathology for prostatectomy after intense neoadjuvant therapy compared with initial T stage. | up to 6 months |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0. All grades of adverse events will be documented. | up to 5 years |
| ID | Term |
|---|---|
| D000069501 | Abiraterone Acetate |
| D011239 | Prednisolone |
| C540278 | enzalutamide |
| C572045 | apalutamide |
| D000067856 | Poly(ADP-ribose) Polymerase Inhibitors |
| ID | Term |
|---|---|
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |
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