Focal Therapy for Localized Prostate Cancer

Withdrawn

• Conditions: Prostate Cancer

• Registration Number: NCT03970863
• Lead Sponsor: China Medical University Hospital

Brief Summary

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 Timeline

• Study First Submitted: 2019-05-27
• Study First Submitted QC: 2019-05-30
• Study First Posted: 2019-06-03
• Study Start: 2020-08-01
• Primary Completion: 2020-11-10
• Study Completion: 2021-11-10
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-07
• Last Update Posted: 2024-02-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
biochemical outcome	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)
oncological outcome	6 months	MR/US fusion prostate biopsy to see if there is recurrent cancer

Secondary Outcome Measures

Name	Time	Method
Functional outcome	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

Trial Locations

Locations (1)

China Medical University Hospital; 🇨🇳 Taichung, Taiwan