An observational study in Prostate Cancer, sponsored by Singapore General Hospital. Recruiting at 1 site in Singapore. Open to male participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-07-08.
Sponsored by Singapore General Hospital · Observational
This is a multicenter observational study of patients undergoing focal therapy for prostate cancer in Asia
Patients undergoing Focal Cryotherapy, Focal HIFU, Focal IRE, Focal Laser ablation, or other partial gland ablation modalities for prostate cancer will be recruited.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's planned enrollment of 500 is above the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Singapore General Hospital is the lead sponsor of 266 studies on the registry; 57 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with limited volume prostate cancer undergoing focal therapy (FT).
Exclusion Criteria:
Patients undergoing focal therapy (various modalities) for prostate cancer as defined by partial gland ablation of \<75% of the prostate gland.
Device: Focal Therapy for Prostate Cancer
Ablation of \<75% of the prostate gland for limited volume prostate cancer
Also known as: Cryotherapy, High Intensity Focused Ultrasound (HIFU), Irreversible Electroporation (IRE), Nanoknife, HIFU, Cryoablation, Laser, Microwave ablation
Overall Survival
Living at 20 years after treatment
Time frame: 20 years
Metastasis-Free Survival
Metastasis Free at 20 years after treatment
Time frame: 20 years
Progression-Free Survival
Progression-Free (Local or Systemic) at 20 years after treatment
Time frame: 20 years
Short-term Clinically Significant Prostate Cancer Recurrence
12-18 month infield and outfield recurrence rate
Time frame: 18 months
Intermediate-term Clinically Significant Prostate Cancer Recurrence
5 year infield and outfield recurrence rate
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 12 months
Radical Intervention-free Survival
Free of Radical Prostatectomy or Radiation at 5 years
Time frame: 5 years
Treatment Failure-free Survival
Free of Radical Prostatectomy, Radiation, Whole-gland Ablation, Hormonal Therapy to Transition to Watchful Waiting at 5 years
Time frame: 5 years
Intervention-Free Survival
Intervention (Focal or Whole Gland/ Radical)-free at 20 years
Time frame: 20 years
Radical Intervention-Free Survival
Radical Intervention (Radical Prostatectomy or Radiation)-Free at 20 years
Time frame: 20 years
Failure-Free Survival
Failure (Whole Gland/ Radical intervention, use of Hormonal Therapy or transition to Watchful Waiting)-free at 10 years
Time frame: 10 years
Failure-Free Survival
Failure (Whole Gland/ Radical intervention, use of Hormonal Therapy or transition to Watchful Waiting)-free at 20 years
Time frame: 20 years
Inter-modality Comparison of short-term Oncological Outcomes
Comparison of 12-month infield and outfield recurrence rates between different focal therapy modalities
Time frame: 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
Time frame: 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
Time frame: 10 years
Inter-modality Comparison of Metastasis Rates
Comparison of 10 year metastasis-rate between different modalities
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months
Plan to share: Undecided
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Singapore General Hospital