Focal Therapy for Localized Prostate Cancer

February 7, 2024 updated by: Po-Fan Hsieh, China Medical University Hospital

China Medical University Hospital, Taichung, Taiwan

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

Study Overview

Status

Withdrawn

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

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taichung, Taiwan, 404
        • China Medical University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

prostate cancer patients in a tertiary referral center in Taiwan

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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)
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

This is where you will find people and organizations involved with this study.

Sponsor

China Medical University Hospital

Investigators

  • Principal Investigator: Po-Fan Hsieh, China Medical University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2020

Primary Completion (Estimated)

November 10, 2020

Study Completion (Estimated)

November 10, 2021

Study Registration Dates

First Submitted

May 27, 2019

First Submitted That Met QC Criteria

May 30, 2019

First Posted (Actual)

June 3, 2019

Study Record Updates

Last Update Posted (Estimated)

February 9, 2024

Last Update Submitted That Met QC Criteria

February 7, 2024

Last Verified

February 1, 2024

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

No

Studies a U.S. FDA-regulated device product

No

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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