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| ID | Type | Description | Link |
|---|---|---|---|
| B2025-816 | Other Identifier | Sun Yat-sen University Cancer Center |
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The goal of this clinical trial is to evaluate whether the addition of pelvic radiotherapy to androgen deprivation therapy (ADT) can delay disease progression and improve survival outcomes in patients with pathologically confirmed regional lymph node-positive (pN1) prostate cancer after radical prostatectomy.
The main questions it aims to answer are:
Researchers will compare ADT plus pelvic radiotherapy with ADT alone to see if combined treatment improves disease control and long-term clinical outcomes.
Participants with positive lymph nodes after prostatectomy will be randomly assigned in a 2:1 ratio to receive ADT plus pelvic radiotherapy, or ADT alone. ADT will be administered for 2 years. Patients with radiologically detectable pelvic recurrence or distant metastases after radical prostatectomy will be excluded. Safety, adverse events, and health-related quality of life will be assessed during follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiotherapy arm | Experimental | Patients will receive pelvic radiotherapy and androgen deprivation therapy for 2 years. |
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| ADT arm | Active Comparator | Patients will receive androgen deprivation therapy alone for 2 years. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Androgen Deprivation Therapy (ADT) | Drug | Androgen deprivation therapy includes available GnRH agonists and antagonists, such as Triptorelin, Leuprolide, Goserelin and Degarelix. No novel hormonal therapy is allowed. |
| Measure | Description | Time Frame |
|---|---|---|
| Biochemical progression-free survival | Time from randomization to PSA ≥ 0.4 ng/mL with subsequent rise, PSA ≥ 1.0 ng/mL at any time, clinical or radiographic progression, or death from any cause. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical recurrence-free survival | The time from randomization to first radiographic progression or death from any cause. | 5 years |
| Locoregional failure free survival | The time from randomization to the first occurrence of locoregional recurrence (prostate bed or pelvic lymph nodes) or death from any cause. |
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Inclusion Criteria:
Hemoglobin ≥ 90 g/L Platelet count ≥ 75 × 10⁹/L Total bilirubin ≤ 3 × ULN AST or ALT ≤ 5 × ULN
Use of effective contraception during the study and for 3 months after.
Written informed consent provided, with willingness and ability to comply with study visits, treatments, and procedures.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liru He, PhD | Contact | +862087343030 | helir@sysucc.org.cn | |
| Yang Liu, MD | Contact | +862087341521 | liuyang1@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Liru He, PhD | Sun Yat-Sen University Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dongguan People's Hospital | Not yet recruiting | Dongguan | Guangdong | China |
Due to local law
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Statistician
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| radiotherapy | Radiation | Radiotherapy will be administered using IMRT or VMAT techniques. Radiation fields will include the pelvic lymph node drainage areas, with inclusion of the prostate bed in patients with pT3-4 disease or positive surgical margins. |
|
| 5 years |
| Metastasis-free survival | The time from randomization to the first occurrence of distant metastasis (excluding pelvic lymph nodes) or death from any cause. | 5 years |
| Post-operative biochemical progression-free survival | Time from surgery to PSA ≥ 0.4 ng/mL with subsequent rise, PSA ≥ 1.0 ng/mL at any time, clinical or radiographic progression, or death from any cause. | 5 years |
| Freedom from non-protocol hormone therapy | Time from randomization to initiation of non-protocol-specified hormonal therapy, including additional hormonal agents or re-initiation of castration therapy without meeting progression criteria. | 5 years |
| Freedom from castration resistance survival | Time from randomization to CRPC or death from any cause, with CRPC defined according to PCWG3 criteria. | 5 years |
| Overall survival | The time from randomization to death from any cause. | 5 years |
| Prostate cancer-specific survival | The time from randomization to death directly attributable to prostate cancer. | 5 years |
| Adverse Events | Adverse events assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. | 5 years |
| Health-Related Quality of Life | Changes from baseline in global health status and functional/symptom scores measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). | 5 years |
| Prostate Cancer-Specific Quality of Life | Changes from baseline in prostate cancer-specific quality of life measured using the EORTC QLQ-PR25 module. | 5 years |
| Anxiety and Depression | Changes from baseline in anxiety and depression measured using the Hospital Anxiety and Depression Scale (HADS). | 5 years |
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
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| The First Affiliated Hospital of Guangzhou Medical University | Not yet recruiting | Guangzhou | Guangdong | China |
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| The First Affiliated Hospital, Sun Yat-sen University | Not yet recruiting | Guangzhou | Guangdong | China |
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| Affiliated Hospital of Guangdong Medical University | Not yet recruiting | Zhanjiang | Guangdong | China |
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| Henan Cancer Hospital | Recruiting | Zhengzhou | Henan | China |
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| West China Hospital, Sichuan University | Recruiting | Chengdu | Sichuan | China |
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| The First Affiliated Hospital, Zhejiang University School of Medicine | Not yet recruiting | Hangzhou | Zhejiang | China |
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| Beijing Hospital | Recruiting | Beijing | China |
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| Cancer Hospital, Chinese Academy of Medical Sciences | Not yet recruiting | Beijing | China |
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| Peking University First Hospital | Recruiting | Beijing | China |
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| Peking University Third Hospital | Not yet recruiting | Beijing | China |
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| The First Affiliated Hospital of Naval Medical University | Not yet recruiting | Shanghai | 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 |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000726 | Androgen Antagonists |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D006727 | Hormone Antagonists |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D013812 | Therapeutics |
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