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To evaluate: The radiographic progression-free survival (rPFS) of metastatic hormone-sensitive prostate cancer (mHSPC) patients treated with androgen deprivation therapy (ADT) + second-generation antiandrogens±chemotherapy combined with cytoreductive prostatectomy (CRP)
To investigate the multimodality approaches for mHSPC
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Local treatment group | Experimental | Triplet or doublet therapy followed by cytoreductive prostatectomy or brachytherapy |
|
| SOC group | Active Comparator | Triplet or doublet therapy (ie. docetaxel/abiraterone, apalutamide,Rezvilutamide,darolutamide,enzalutamide) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cytoreductive prostatectomy or brachytherapy | Procedure | local treatment+SOC for metastatic prostate cancer |
|
| Measure | Description | Time Frame |
|---|---|---|
| rPFS | Assess how long a cancer patient lives without any signs of progression of their disease, as determined by radiographic evidence | 3 year |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of CRP in mHSPC patients | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | until one year after the local therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lixin Hua, M.D. | Contact | 13072564303 | hlx5858@163.com | |
| Shangqian Wang, M.D.,PhD | Contact | 13770561625 | wsq5501@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Lixin Hua, M.D. | The First Affiliated Hospital with Nanjing Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Nanjing Medical University | Recruiting | Nanjing | Jiangsu | 210029 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Mar 20, 2024 |
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randomized control
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| ADT+second-generation antiandrogens ± chemotherapy | Drug | SOC(Triplet or doublet therapy) for mHSPC |
|
|
| Mar 20, 2024 |
| Prot_ICF_000.pdf |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D023801 | Directly Observed Therapy |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D055118 | Medication Adherence |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D001918 | Brachytherapy |
| D013514 | Surgical Procedures, Operative |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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