- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03970863
Focal Therapy for Localized Prostate Cancer
China Medical University Hospital, Taichung, Taiwan
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Contacts and Locations
Study Contact
- Name: Po-Fan Hsieh
- Phone Number: 4439 886-4-22052121
- Email: D17341@mail.cmuh.org.tw
Study Locations
-
-
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Taichung, Taiwan, 404
- China Medical University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
oncological outcome
Time Frame: 6 months
|
MR/US fusion prostate biopsy to see if there is recurrent cancer
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6 months
|
biochemical outcome
Time Frame: 1 month, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months
|
change of Prostate Health Index (PSA, free PSA, and p2PSA will be combined to report PHI)
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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
Time Frame: 1 month, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months
|
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
Time Frame: 1 month, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months
|
change of IPSS questionnaire
|
1 month, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months
|
Functional outcome
Time Frame: 1 month, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months
|
change of OABSS questionnaire
|
1 month, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months
|
Functional outcome
Time Frame: 1 month, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months
|
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
Time Frame: 1 month, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Po-Fan Hsieh, China Medical University Hospital
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMUH107-REC3-119
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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