Focal Therapy for Localized Prostate Cancer

NCT ID: NCT03970863

Last Updated: 2024-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-01

Study Completion Date

2021-11-10

Brief Summary

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To evaluate the cancer control for prostate cancer patients treated with focal therapy.

Detailed Description

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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

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Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Prostate Health Index

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Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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China Medical University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Po-Fan Hsieh

Attending Urologist, Department of Urology, China Medical University Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Po-Fan Hsieh

Role: PRINCIPAL_INVESTIGATOR

China Medical University Hospital

Locations

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China Medical University Hospital

Taichung, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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CMUH107-REC3-119

Identifier Type: -

Identifier Source: org_study_id

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