Prospective Asian Multicenter Prostate Cancer Focal Therapy Study (ProAMFocal)
NCT Number: NCT06491056
Acronym: ProAMFocal
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Prostate Cancer
Interventions: DEVICE: Focal Therapy for Prostate Cancer
Sponsor: Singapore General Hospital
Collaborators: National Medical Research Council (NMRC), Singapore
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-05-06
Completion Date: 2048-05-06
Locations: Singapore General Hospital, Singapore, 169856, Singapore

Summary:
This is a multicenter observational study of patients undergoing focal therapy for prostate cancer in Asia

Primary Outcome Measures: Overall Survival, Living at 20 years after treatment, 20 years|Metastasis-Free Survival, Metastasis Free at 20 years after treatment, 20 years|Progression-Free Survival, Progression-Free (Local or Systemic) at 20 years after treatment, 20 years|Short-term Clinically Significant Prostate Cancer Recurrence, 12-18 month infield and outfield recurrence rate, 18 months|Intermediate-term Clinically Significant Prostate Cancer Recurrence, 5 year infield and outfield recurrence rate, 5 years|Sexual Function, Change in Expanded Prostate Index Composite (EPIC) Sexual Summary Score (0-100, with 100 being the maximum) post-Focal Therapy (FT) compared to baseline at 1,3, 6, 12 months, 12 months|Urinary Function, Change in Expanded Prostate Index Composite (EPIC) Urinary Summary Score (0-100, with 100 being the maximum) post-FT compared to baseline at 1,3, 6, 12 months, 12 months|Bowel Function, Change in Expanded Prostate Index Composite (EPIC) Bowel Summary Score (0-100, with 100 being the maximum) post-FT compared to baseline at 1,3, 6, 12 months, 12 months|Radical Intervention-free Survival, Free of Radical Prostatectomy or Radiation at 5 years, 5 years|Treatment Failure-free Survival, Free of Radical Prostatectomy, Radiation, Whole-gland Ablation, Hormonal Therapy to Transition to Watchful Waiting at 5 years, 5 years
Secondary Outcome Measures: Intervention-Free Survival, Intervention (Focal or Whole Gland/ Radical)-free at 20 years, 20 years|Radical Intervention-Free Survival, Radical Intervention (Radical Prostatectomy or Radiation)-Free at 20 years, 20 years|Failure-Free Survival, Failure (Whole Gland/ Radical intervention, use of Hormonal Therapy or transition to Watchful Waiting)-free at 10 years, 10 years|Failure-Free Survival, Failure (Whole Gland/ Radical intervention, use of Hormonal Therapy or transition to Watchful Waiting)-free at 20 years, 20 years
Other Outcome Measures: Inter-modality Comparison of short-term Oncological Outcomes, Comparison of 12-month infield and outfield recurrence rates between different focal therapy modalities, 12 months|Inter-modality Comparison of Conversion to Radical Treatment Rates, Comparison of 10 year conversion to radical treatment (Radical Prostatecomy or Radiation) between different modalities, 10 years|Inter-modality Comparison of Treatment Failure Rates, Comparison of 10 year failure (Radical Prostatectomy or Radiation or Hormonal Therapy or transition to Watchful Waiting) between different modalities, 10 years|Inter-modality Comparison of Metastasis Rates, Comparison of 10 year metastasis-rate between different modalities, 10 years|Inter-modality Comparison of Sexual Function Outcomes, Comparing mean change in Expanded Prostate Index Composite (EPIC) Sexual Summary Score (0-100, with 100 being the best function) post-FT compared to baseline at 1,3, 6, 12 months between different modalities., 12 months|Inter-modality Comparison of Urinary Function Outcomes, Comparing mean change in Expanded Prostate Index Composite (EPIC) Urinary Summary Score (0-100, with 100 being the best function) post-FT compared to baseline at 1,3, 6, 12 months between different modalities., 12 months|Inter-modality Comparison of Bowel Function Outcomes, Comparing mean change in Expanded Prostate Index Composite (EPIC) Bowel Summary Score (0-100, with 100 being the best function) post-FT compared to baseline at 1,3, 6, 12 months between different modalities., 12 months