Prostate CancerNCT03970863
Focal Therapy for Localized Prostate Cancer
An observational study of Prostate Cancer, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
To evaluate the cancer control for prostate cancer patients treated with focal therapy. Read more about this study
- Who is it for?
- Ages 40 to 90 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Prostate Health Index
- How many people
- 0 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2020to 10 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: prostate cancer patients in a tertiary referral center in Taiwan
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: China Medical University Hospital, Taichung, Taiwan
To evaluate the cancer control for prostate cancer patients treated with focal therapy.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Prostate Health Index
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostate Health IndexDiagnostic test
Use Prostate Health Index for the follow-up after focal therapy.
What is being measured
The primary outcome is the main question the study is designed to answer.
oncological outcome
MR/US fusion prostate biopsy to see if there is recurrent cancer
Measured: 6 months
biochemical outcome
change of Prostate Health Index (PSA, free PSA, and p2PSA will be combined to report PHI)
Measured: 1 month, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months
Secondary outcomes (5)
Functional outcome
change of Uroflowmetry, including maximal flow rate in milliliter per second and post-void residual volume in milliliter
Measured: 1 month, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months
Functional outcome
change of IPSS questionnaire
Measured: 1 month, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months
Functional outcome
change of OABSS questionnaire
Measured: 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
Measured: 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
Measured: 1 month, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start1 Aug 2020 (estimated)
- Primary completion10 Nov 2020 (estimated)
- Study completion10 Nov 2021 (estimated)
Why it stopped: difficulty in recruiting participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Po-Fan Hsieh, China Medical University Hospital
- Investigators
- Po-Fan Hsieh, Principal investigator, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03970863
- Sponsor's protocol ID
- CMUH107-REC3-119
- Status last verified
- Feb 2024
- First submitted
- 27 May 2019
- Last updated
- 9 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China Medical University Hospital, Taichung, Taiwan
- ClinicalTrials.gov ID
- NCT03970863
- Acronym / sponsor ID
- CMUH107-REC3-119
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: difficulty in recruiting participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2020 (estimated)
- Primary completion
- 10 Nov 2020 (estimated)
- Study completion
- 10 Nov 2021 (estimated)
- First posted
- 3 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- prostate cancer patients in a tertiary referral center in Taiwan
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prostate Health IndexUse Prostate Health Index for the follow-up after focal therapy. | Diagnostic test | – |
Primary outcome
oncological outcome
Time frame: 6 months
MR/US fusion prostate biopsy to see if there is recurrent cancer
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)
5 secondary outcomes
Functional outcome
Time frame: 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
Functional outcome
Time frame: 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
Functional outcome
Time frame: 1 month, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Po-Fan Hsieh principal investigator
China Medical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oncological outcome (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2024.