Focal Therapy for Localized Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
To evaluate the cancer control for prostate cancer patients treated with focal therapy.

Detailed Description
-----------------
Traditional treatments for localized prostate cancer are radical prostatectomy and radiotherapy. However, they would carry side effects including urinary incontinence, sexual dysfunction, radiation cystitis and proctitis, leading to great impact on quality of life. Focal therapy of is another emerging treatment strategy for localized prostate cancer. It aims on ablation of the tumor with sparing of healthy prostatic tissue in order to minimize the injury to urinary and sexual function. Besides, owing to the improvement of multiparametric magnetic resonance imaging (mpMRI), the investigators can localize the prostate cancer more precisely and the accessibility of focal therapy is also increased. Literature showed focal ablation of HIFU or cryotherapy for low and intermediate-risk prostate cancer patients yielded in brilliant outcomes. Biopsy in post-treatment one year showed 87% and 94.6% were negative for clinically significant cancer, respectively. Up to 92% of patients did not need salvage treatment in two years. Ninety-one to one hundred precent of patients had no urinary incontinence, and 74% and 81.5% had no erectile dysfunction, respectively. This prospective study aims to evaluate the cancer control and quality of life for prostate cancer patients treated with focal therapy.

Official Title
-----------------
China Medical University Hospital, Taichung, Taiwan

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: Prostate Health Index


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: biopsy-proven unilateral prostate cancer, the other side insignificant cancer (Gleason 6 or less and maximal cancer core length 4mm or less) is allowed clinical T2a or less Gleason 4+3 or less serum PSA less than 20 ng/mL Exclusion Criteria: T2b or higher Gleason 4+4 or higher serum PSA 20 or higher lymph node or distant metastasis previous treatment with prostatectomy, radiotherapy, androgen deprivation therapy, HIFU, or cryoablation

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Prostate Health Index|Use Prostate Health Index for the follow-up after focal therapy.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oncological outcome | MR/US fusion prostate biopsy to see if there is recurrent cancer | 6 months | 
| biochemical outcome | change of Prostate Health Index (PSA, free PSA, and p2PSA will be combined to report PHI) | 1 month, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional outcome | change of Uroflowmetry, including maximal flow rate in milliliter per second and post-void residual volume in milliliter | 1 month, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months | 
| Functional outcome | change of IPSS questionnaire | 1 month, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months | 
| Functional outcome | change of OABSS questionnaire | 1 month, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months | 
| Functional outcome | change of IIEF-5 questionnaire | 1 month, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months | 
| Functional outcome | change of EORTC QLQ-30/PR-25 questionnaire | 1 month, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months |