Initial Experience in Brazilian Single Center With High Intensity Focalized Ultrasound (HIFU) Prostate Cancer Therapy: Morbidity, Oncological and Functional Outcomes.

NCT03255135 | Unknown DMC

• 1 other identifier: HIFU01
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

Prostate cancer (PCa) is the most prevalent non cutaneous cancer in occidental countries. In Brazil incidence was about sixty thousand new cases in 2016 and occupied second place as all cancer mortality, just behind lung cancer. Literature shows than younger patients tend to have more aggressive tumors rising cancer specific mortality scores. Main risk factors are age, life style (sedentary, high meat and fat intake) and family history (gene inheritance). Besides vast advances in precocious tumors detection, challenges remain in the definition of the biological status of the tumor, which is highly variable and full of prognostic implications. PCa heterogeneity is demonstrated by the uncertain natural history, varying from indolent lesion to aggressive metastatic and fast progression cancer resistant to conventional therapies. In an actual treatment scenario, prognostic identification is the cornerstone of daily practice treatment considering the natural history variability cited before and the discrepancy of long term slow growth (studies estimate eight to sixteen years of tumor growth to achieve metastatic disease) to high grade aggressive cancer. Considering all this background and taking in account the indolent evolution of low risk PCa new therapies emerge with promising outcomes. High-Intensity Focused Ultrasound (HIFU) have to be highlighted due to easy operation, good oncologic results and low complication profile. The method is based on real-time imaging guided high intensity ultrasound (US) causing overheat and cavitation in the focused tissue. Applied since 90's, mainly in German and French groups, initially programmed to treat hole gland preserving only urinary sphincter and bladder neck, showed recently some data on 1700 patients, 5 years biochemical recurrence free survival of 80% and best results including morbidity profile in low risk, low prostate volume and in the group with previous trans urethral prostate resection (TURP). This results are very similar to other radical treatment options with median follow up of 8 years, cancer specific survival 98% and metastasis free survival of 95% If local recurrence was identified another HIFU ablation or even radical treatment achieved good results in local control with acceptable morbidity profile. Focal treatment is a new entity in PCa therapy. One randomized trial compared focal treatment to active surveillance in 513 mans with PCa diagnosis. With a 24 month follow-up progression-free ratios (28% x 58%) and positive control prostate biopsy ratios (14% x 49%) were fairly superior in treatment group. This exiting novel data turns urological oncology paths to the new era of minimally harmful therapy with targeted focused procedure. At our knowledge there is no high evidence clinical trial comparing HIFU to active surveillance. The objective of this study is to evaluate prospectively the initial experience with 50 patients submitted to HIFU therapy for low risk prostate cancer in Brazilian single center considering the following aspects: One year of treatment prostate biopsy positiveness; Biochemical recurrence free survival using Phoenix and Stuttgart criteria in one year; Sexual function using IIEF-5 questionnaire and the usage of 5-phosphodiesterase inhibitors (5-PDI); Urinary symptoms using EPIC and IPSS questionnaires and free urinary flow; Quality of life based on SF-36 questionnaire evaluation; Post procedure morbidity using Clavien-Dindo classification.

Conditions

Prostate Cancer; Prostate Adenocarcinoma; Transrectal High Intensity Focused Ultrasound

Outcome Measures

Primary Outcomes (2)

• Prostate cancer biochemical recurrence free survival after prostate cancer focal therapy

  Biochemical recurrence free survival using Phoenix criteria in one year

  12 months

• Prostate cancer pathological persistence after prostate cancer focal therapy

  One year post-HIFU treatment prostate biopsy positivity

  12 months

Secondary Outcomes (7)

• IIEF-5 - Sexual function after prostate cancer focal therapy

  12 months

• 5-PDI - Sexual function after prostate cancer focal therapy

  12 months

• Free urinary flow - Urinary symptoms after prostate cancer focal therapy

  12 months

• EPIC - Urinary symptoms after prostate cancer focal therapy

  12 months

• IPSS - Urinary symptoms after prostate cancer focal therapy

  12 months

Study Arms (1)

HIFU

EXPERIMENTAL

Patients with untreated recent diagnosed localized prostate cancer candidates of focal therapy.

Device: HIFU

Interventions

HIFU DEVICE

High intensity focused ultrasound prostate cancer therapy guided by biopsy specimens and multiparametric prostate magnetic resonance using Focal One, Edap TMS, France device.

HIFU

Eligibility Criteria

• Age: 30 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patients with recent diagnosis of usual adenocarcinoma of prostate untreated and with indication of specific treatment by the assisting urologist;
• \. And low or intermediate prostate cancer in clinical staging;
• \. And concordance with the clinical trial by signing the terms.

You may not qualify if:

• \. Other types of prostate cancer not usual adenocarcinoma;
• \. Or any previous treatment to prostate cancer;
• \. Or any patient who presents with proctologic abnormalities;

Sponsors & Collaborators

• Hospital de Transplante Doutor Euryclides de Jesus Zerbini: lead

Study Sites (1)

Hospital de Transplantes Euryclides de Jesus Zerbini

São Paulo, 01401901, Brazil

Location

Related Publications (22)

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MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2017
• First Posted: August 21, 2017
• Study Start: May 31, 2018
• Primary Completion: May 31, 2019
• Study Completion: July 1, 2019
• Last Updated: June 27, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)