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临床试验/NCT07792590
NCT07792590招募中不适用

Prospective Database / Registry of Focal Therapy for Prostate Cancer

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年10月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
The surgical outcomes of focal therapies.

研究概览

简要总结

Whole gland therapy (radical prostatectomy and radiotherapy) has been the conventional treatment for localized prostate cancer, but randomized controlled trials have not demonstrated survival benefits compared with watchful waiting or active surveillance. Whole gland therapy is also associated with significant long-term sequelae including urinary incontinence, erectile dysfunction, irradiation cystitis, and proctitis. Focal therapy has emerged as an alternative treatment modality, yet more data are needed to ensure its safety and efficacy. This is a prospective database/registry study designed to record all pre-operative, intra-operative, and post-operative parameters for patients undergoing focal therapies for prostate cancer, including but not limited to cryotherapy, high-intensity focused ultrasound (HIFU), focal laser therapy (FLA), irreversible electroporation (IRE), targeted microwave ablation (TMA). All patients who have undergone focal therapy at the Department of Surgery, Queen Mary Hospital for prostate cancer will be invited to participate, except those incapable of providing written informed consent. The primary outcome is the surgical outcomes (complications and effectiveness) of focal therapies. Secondary outcomes include identification of risk factors for treatment-related complications, provision of a readily available dataset for subsequent research, and identification of the best treatment allocation for prostate cancer patients. An estimated 200 patients will be included, with data collection from study start until 31 March 2030.

详细描述

Background and Rationale

Whole gland therapy (i.e. radical prostatectomy and radiotherapy) has been the conventional treatment for localized prostate cancer for years. However, randomized controlled trials have not shown survival benefits with whole gland therapy comparing with watchful waiting or active surveillance. There is therefore a rising trend of exploring focal therapy for localized prostate cancer as an alternative, as whole gland therapy has significant long-term sequelae, such as urinary incontinence and erectile dysfunction for prostatectomy, and irradiation cystitis and proctitis for radiotherapy. More data are needed to ensure the safety and efficacy of focal therapy.

Study Design

This is a prospective database/registry study to record all pre-operative, intra-operative and post-operative parameters for the following, but not exclusively, focal therapies: cryotherapy, high-intensity focused ultrasound (HIFU), focal laser therapy (FLA), and irreversible electroporation (IRE).

Data Collection Parameters

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Patients who have undergone focal therapies for prostate cancer at the Department of Surgery, Queen Mary Hospital
  • Includes but not limited to: cryotherapy, high-intensity focused ultrasound (HIFU), focal laser therapy (FLA), and irreversible electroporation (IRE)
  • Willing and able to provide written informed consent

排除标准

  • Patients who are incapable to provide written informed consent.

研究组 & 干预措施

Prostate Cancer Focal Therapy Registry

Patients with prostate cancer who have undergone focal therapies including cryotherapy, high-intensity focused ultrasound (HIFU), focal laser therapy (FLA), and irreversible electroporation (IRE) at the Department of Surgery, Queen Mary Hospital. Pre-operative, intra-operative, and post-operative parameters are prospectively collected. Primary outcome is surgical outcomes (complications and effectiveness). Secondary outcomes include identification of risk factors for complications, provision of a dataset for subsequent research, and identification of best treatment allocation.

干预措施: Focal Therapy for Prostate Cancer (Procedure)

结局指标

主要结局

The surgical outcomes of focal therapies.

时间窗: Through study completion, an average of 5 years

Complications and effectiveness of focal therapies for prostate cancer

次要结局

  • Risk factors for treatment-related complications(Through study completion, an average of 5 years)
  • Pre-operative, intra-operative, and post-operative parameters for subsequent research on focal therapy(Throughout the study data collection period, an average of 5 years)
  • Treatment allocation and outcomes by focal therapy modality(At data analysis, 2.5 years after the first recruitment of patient)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

LEUNG SHUNG LAI JOHN

Professor

The University of Hong Kong

研究点 (1)

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