Focal Therapy for Localized Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

China Medical University Hospital, Taichung, Taiwan

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03970863
• Other study ID #: CMUH107-REC3-119
• Status: Withdrawn
• Start date: August 1, 2020
• Est. completion date: November 10, 2021

Study information

• Verified date: February 2024
• Source: China Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 10, 2021
• Est. primary completion date: November 10, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Diagnostic Test:
• Prostate Health Index
Use Prostate Health Index for the follow-up after focal therapy.

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	oncological outcome	MR/US fusion prostate biopsy to see if there is recurrent cancer	6 months
Primary	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	Functional outcome	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
Secondary	Functional outcome	change of IPSS questionnaire	1 month, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months
Secondary	Functional outcome	change of OABSS questionnaire	1 month, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months
Secondary	Functional outcome	change of IIEF-5 questionnaire	1 month, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months
Secondary	Functional outcome	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