Study Stopped
difficulty in recruiting participants
Focal Therapy for Localized Prostate Cancer
China Medical University Hospital, Taichung, Taiwan
1 other identifier
observational
N/A
1 country
1
Brief Summary
To evaluate the cancer control for prostate cancer patients treated with focal therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Aug 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 27, 2019
CompletedFirst Posted
Study publicly available on registry
June 3, 2019
CompletedStudy Start
First participant enrolled
August 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 10, 2021
CompletedFebruary 9, 2024
February 1, 2024
3 months
May 27, 2019
February 7, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (5)
Functional outcome
1 month, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months
Functional outcome
1 month, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months
Functional outcome
1 month, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months
Functional outcome
1 month, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months
Functional outcome
1 month, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months
Interventions
Use Prostate Health Index for the follow-up after focal therapy.
Eligibility Criteria
prostate cancer patients in a tertiary referral center in Taiwan
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
China Medical University Hospital
Taichung, 404, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Po-Fan Hsieh
China Medical University Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending Urologist, Department of Urology, China Medical University Hospital
Study Record Dates
First Submitted
May 27, 2019
First Posted
June 3, 2019
Study Start
August 1, 2020
Primary Completion
November 10, 2020
Study Completion
November 10, 2021
Last Updated
February 9, 2024
Record last verified: 2024-02