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Evaluate whether the combination of Rezvilutamide and androgen deprivation therapy (ADT) with docetaxel improves overall survival (OS) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) compared to the combination of Rezvilutamide and ADT.
To investigate the value of chemotherapy in the treatment of high-burden of mHSPC on the background of next-genertion of AR inhibitors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rezvilutamide+ADT+Docetaxel | Experimental | Rezvilutamide: 240 mg (3 tablets of 80 mg each) orally once daily (QD), can be taken with or without food. Docetaxel 6 cycles |
|
| Rezvilutamide+ADT | Active Comparator | Rezvilutamide: 240 mg (3 tablets of 80 mg each) orally once daily (QD), can be taken with or without food. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel | Drug | This is Triple drug regimen for mHSPC |
|
| Measure | Description | Time Frame |
|---|---|---|
| rPFS | radiographic Progression-Free Survival | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| prostate-specific antigen (PSA) response rate | percentage of patients with a decreasing PSA following the regimens discussed above | 36 months |
| time to castration-resistant prostate cancer (CRPC) |
| Measure | Description | Time Frame |
|---|---|---|
| time to next bone-related event | Including bone structure, pain, etc. | 36 months |
Inclusion Criteria:
Males aged ≥40 years and ≤80 years.
Histologically or cytologically confirmed prostate adenocarcinoma.
Metastatic disease.
Eligible for ADT and Docetaxel.
Started or not started first-generation androgen deprivation therapy (ADT), but not exceeding 12 weeks before randomization.
ECOG score of 0 or 1.
Laboratory tests meet the following requirements:
Study subjects: Patients with mHSPC have a confirmed pathology of prostate adenocarcinoma with high tumor burden, which is defined by having at least one of the following conditions:
1) Bone scan showing ≥4 bone metastatic lesions (with at least one site outside the pelvis or spine).
2) CT/MRI revealing visceral metastatic lesions (excluding lymph nodes).
Exclusion Criteria:
Patients who meet any of the following criteria are not eligible to participate in this study:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shangqian Wang, M.D., Ph.D. | Contact | +862568303186 | wsq5501@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Lixxin Hua | Urology Dpt, First Affiliated Hospital of Nanjing Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urology dpt, 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 | Aug 2, 2023 |
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| Rezvilutamide | Drug | This is doubling drug regimen for mHSPC |
|
|
time to PSA progression
| 36 months |
| Aug 2, 2023 |
| Prot_ICF_000.pdf |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| 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 |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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