Methods: This is a multinational, multicenter, longitudinal, and observational registry of PC patients presenting to participating tertiary-care hospitals in eight Asian countries (www.clinicaltrials.gov NCT02546908. Registry Identifier: NOPRODPCR4001). Approximately 3500-4000 eligible patients with existing or newly diagnosed high-risk localized PC (cohort 1), nonmetastatic biochemically recurrent PC (cohort 2), or metastatic PC (cohort 3) will be consecutively enrolled and followed-up for 5 years. An enrollment cap of 600 patients each will be applied to cohorts 1 and 2. Disease status is collected at enrollment, and outcome variables captured at 3-monthly intervals include diagnostic/staging, treatments including reason for change, laboratory results, comorbidities, and concomitant medications. Treatments and survival outcomes will be captured real time until study end. Patient-reported quality-of-life will be measured every 6 months, and medical resource utilization summarized at study end. Data analysis will include exploratory analyses of potential associations between multiple risk factors and socioeconomic variables with disease progression and evaluation of various treatments for PC including novel therapies on clinical outcome and health-related quality-of-life outcomes.
Results: 3636 men with PC were enrolled until July 2018; 416 in cohort 1, 399 in cohort 2 and 2821 in cohort 3.
Discussion: A total of 3636 patients were enrolled until July 2018. The prospective disease registry will provide comprehensive and wide-ranging real-world information on how PC is diagnosed and treated in Asia. Such information can be used to inform policy development for best practice and direct clinical study design evaluating new treatments.
METHODS: Over 8 years, men with localized prostate cancer treated with whole-gland HIFU were prospectively followed. Transrectal prostate ablation was performed under general anesthesia with Sonablate-500® (Sonacare Medical©, Charlotte, North Carolina, USA). The primary outcome was failure-free survival defined as no transition to any of the following: (1) local salvage therapy (surgery or radiotherapy), (2) systemic therapy, (3) metastases, or (4) prostate cancer-specific mortality. Secondary outcomes included both survival outcomes and QoL measures.
RESULTS: Of 70 men, 29.7% had International Society of Urological Pathology (ISUP) grade 1, 43.8% ISUP 2, 10.9% ISUP 3, and 15.6% ISUP 4 disease. At median follow-up of 83.4 months, overall mortality was 8.6% and prostate cancer-specific mortality 0%. Failure-free survival was 78.2% at 5 years and 71.2% at 7 years. Of all men, 7.1% of men developed metastases, with median metastasis-free survival of 75.4 months. There was negligible post-HIFU urinary incontinence or lower urinary tract symptom with a median Male Urogenital Distress Inventory score of 32 at 6 months and 33 at 12 months and median IPSS of 4 at 6 months and 3 at 12 months. Median Radiation Therapy Oncology Group rectal toxicity score was 0 throughout. In men who had mild or no erectile dysfunction at baseline (International Index of Erectile Function ≥17), the mean International Index of Erectile Function score declined to 37% from 23.5 at baseline to 14.7 at 12 months.
CONCLUSION: At median follow-up of 7 years, whole-gland HIFU appears to have comparable survival outcomes with other cohort studies involving radical prostatectomy and radiotherapy patient. It has low impact on QoL, preserved urinary continence, and erectile function approximate to nerve-sparing prostatectomy. Whole-gland HIFU presents a potential alternative minimally invasive and safe option for the treatment of localized prostate cancer.