Clinical trial NCT03970863: Focal Therapy for Localized Prostate Cancer
Official title: China Medical University Hospital, Taichung, Taiwan
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Prostate Cancer
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2019-06-03
Enrollment: 0
Sex: MALE
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: prostate cancer patients in a tertiary referral center in Taiwan

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.

Eligibility criteria: 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

Primary outcomes:
measure: oncological outcome
timeFrame: 6 months
measure: biochemical outcome
timeFrame: 1 month, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months
Secondary outcomes:
measure: Functional outcome
timeFrame: 1 month, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months
measure: Functional outcome
timeFrame: 1 month, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months
measure: Functional outcome
timeFrame: 1 month, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months
measure: Functional outcome
timeFrame: 1 month, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months
measure: Functional outcome
timeFrame: 1 month, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: China Medical University Hospital
name: Po-Fan Hsieh
role: PRINCIPAL_INVESTIGATOR
References: