Registry for Prostate Cancer Focal Therapy

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.

Inclusion criteria

• 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

Exclusion criteria

• Patients who are incapable to provide written informed consent.