Prostate Cancer
Conditions
Keywords
focal therapy, cryotherapy, high intensity focused ultrasound, irreversible electroporation, focal laser ablation, Microwave ablation
Brief summary
This is a multicenter observational study of patients undergoing focal therapy for prostate cancer in Asia
Detailed description
Patients undergoing Focal Cryotherapy, Focal HIFU, Focal IRE, Focal Laser ablation, or other partial gland ablation modalities for prostate cancer will be recruited.
Interventions
Ablation of \<75% of the prostate gland for limited volume prostate cancer
Sponsors
National Medical Research Council (NMRC), Singapore
Singapore General Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Prostate Adenocarcinoma * Maximum Gleason score 4+4 * Maximum cancer volume 1.5 ml (up to 2 lesions) or 3 ml (single lesion) * Maximum Prostate Specific Antigen (PSA) level 15 ng/dl * Maximum clinical stage T2c * American Society of Anesthesiologist Criteria 2 or less
Exclusion criteria
* Extra-prostatic Extension on multi parametric magnetic resonance imaging (mpMRI); capsular contact is permitted
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Failure-free Survival | 5 years | Free of Radical Prostatectomy, Radiation, Whole-gland Ablation, Hormonal Therapy to Transition to Watchful Waiting at 5 years |
| Short-term Clinically Significant Prostate Cancer Recurrence | 18 months | 12-18 month infield and outfield recurrence rate |
| Overall Survival | 20 years | Living at 20 years after treatment |
| Metastasis-Free Survival | 20 years | Metastasis Free at 20 years after treatment |
| Progression-Free Survival | 20 years | Progression-Free (Local or Systemic) at 20 years after treatment |
| Intermediate-term Clinically Significant Prostate Cancer Recurrence | 5 years | 5 year infield and outfield recurrence rate |
| Sexual Function | 12 months | 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 |
| Urinary Function | 12 months | 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 |
| Bowel Function | 12 months | 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 |
| Radical Intervention-free Survival | 5 years | Free of Radical Prostatectomy or Radiation at 5 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intervention-Free Survival | 20 years | Intervention (Focal or Whole Gland/ Radical)-free at 20 years |
| Radical Intervention-Free Survival | 20 years | Radical Intervention (Radical Prostatectomy or Radiation)-Free at 20 years |
| Failure-Free Survival | 10 years | Failure (Whole Gland/ Radical intervention, use of Hormonal Therapy or transition to Watchful Waiting)-free at 10 years |
Other
| Measure | Time frame | Description |
|---|---|---|
| Inter-modality Comparison of Metastasis Rates | 10 years | Comparison of 10 year metastasis-rate between different modalities |
| Inter-modality Comparison of Sexual Function Outcomes | 12 months | 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. |
| Inter-modality Comparison of short-term Oncological Outcomes | 12 months | Comparison of 12-month infield and outfield recurrence rates between different focal therapy modalities |
| Inter-modality Comparison of Bowel Function Outcomes | 12 months | 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. |
| Inter-modality Comparison of Urinary Function Outcomes | 12 months | 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. |
| Inter-modality Comparison of Conversion to Radical Treatment Rates | 10 years | Comparison of 10 year conversion to radical treatment (Radical Prostatecomy or Radiation) between different modalities |
| Inter-modality Comparison of Treatment Failure Rates | 10 years | Comparison of 10 year failure (Radical Prostatectomy or Radiation or Hormonal Therapy or transition to Watchful Waiting) between different modalities |
Countries
Singapore
Contacts
Primary ContactKae Jack Tay, MBBS
Outcome results
None listed