Registry for Prostate Cancer Focal Therapy

Overview

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.

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 Pre-operative parameters: age, medical comorbidities, prostatic specific antigen (PSA), multi-parametric magnetic resonance imaging (mpMRI) findings, prostate biopsy method and pathology result, Prostate Specific Membrane Antigen (PSMA) scan result (if applicable), sexual and continence function assessment. Intra-operative parameters: method of anaesthesia, details of operations, post-operative hospital stay, post-operative complications, post-operative pain score. Post-operative parameters: post-operative PSA, sexual and continence function assessment, mpMRI findings, prostate biopsy result, cancer status, death. Aim of Study To determine the effectiveness and safety of focal therapies in treating prostate cancer. Primary Outcome The surgical outcomes (complications and effectiveness) of focal therapies. Secondary Outcomes To identify the risk factors for treatment related complications To provide a readily available dataset for subsequent research on focal therapy To identify the best treatment allocation for prostate cancer patients Inclusion Criteria and Subject Identification All patients who had undergone focal therapies including but not limited to cryotherapy, high-intensity focused ultrasound (HIFU), focal laser therapy (FLA), and irreversible electroporation (IRE) surgeries performed under Department of Surgery, Queen Mary Hospital for prostate cancer will be invited to participate, except patients who are incapable to provide written informed consent. Estimated Sample Size Estimated number of patients fulfilling criteria: 200 Data Collection Period Study start to 31 March 2030 Statistical Analysis The study will be analysed with SPSS software using descriptive statistics, t-test and proportional testing. Any hypothesis test result with p\<0.05 will be deemed significant. Data Access and Handling To protect patient privacy, all research data will be handled in line with Hospital Authority's or Hospital's policy in handling/storage/destruction of patients' medical records. They would be locked in cabinets where the department/ward keep patients' medical records. Electronic data would be saved in secured computer of the hospital with restricted access. USB Device would not be used for patient information for personal data. Personal data (name, HKID, address and any other personal identifiable information) should not be recorded on the projects' data sheets or electronic files. A study code will be used. Any documents or electronic files containing personal identifiable information would be considered as part of the medical record and will be dealt with the same stringent regulations of security according to the hospital policies. The principal investigator/co-investigator will be responsible for the execution of data protection. Only Principal investigator and delegated study staff will have access to the data during and after the study. Collected study data will be kept for 5 years after the completion of the study. After that, study data will be condemned according to Hospital Authority standard of handling privacy data. Ethical Considerations There is no major ethical concerns since this is only a review of outcomes and patient data with no new data generated for the study. Principal investigator will ensure only data in need are collected and no sensitive data such as name and patient contact are collected. Financing and Insurance No additional financing or insurance requirements necessary. Declaration This study complies with the Declaration of Helsinki.