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

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ClinicalTrials.gov Identifier: NCT03255135
Recruitment Status : Recruiting
First Posted : August 21, 2017
Last Update Posted : August 10, 2018
Sponsor:
Information provided by (Responsible Party):
Hospital de Transplante Doutor Euryclides de Jesus Zerbini

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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Prostate Adenocarcinoma Transrectal High Intensity Focused Ultrasound Device: HIFU Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Initial Experience in Brazilian Single Center With High Intensity Focalized Ultrasound (HIFU) Prostate Cancer Therapy: Morbidity, Oncological and Functional Outcomes.
Actual Study Start Date : May 31, 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HIFU
Patients with untreated recent diagnosed localized prostate cancer candidates of focal therapy.
Device: HIFU
High intensity focused ultrasound prostate cancer therapy guided by biopsy specimens and multiparametric prostate magnetic resonance using Focal One, Edap TMS, France device.




Primary Outcome Measures :
  1. Prostate cancer biochemical recurrence free survival after prostate cancer focal therapy [ Time Frame: 12 months ]
    Biochemical recurrence free survival using Phoenix criteria in one year

  2. Prostate cancer pathological persistence after prostate cancer focal therapy [ Time Frame: 12 months ]
    One year post-HIFU treatment prostate biopsy positivity


Secondary Outcome Measures :
  1. IIEF-5 - Sexual function after prostate cancer focal therapy [ Time Frame: 12 months ]
    Sexual function using IIEF-5 questionnaire

  2. 5-PDI - Sexual function after prostate cancer focal therapy [ Time Frame: 12 months ]
    Sexual function using evaluation of usage of 5-Phosphodiesterase inhibitors (5-PDI)

  3. Free urinary flow - Urinary symptoms after prostate cancer focal therapy [ Time Frame: 12 months ]
    Urinary symptoms using free urinary flow measure

  4. EPIC - Urinary symptoms after prostate cancer focal therapy [ Time Frame: 12 months ]
    Urinary symptoms using EPIC questionnaire

  5. IPSS - Urinary symptoms after prostate cancer focal therapy [ Time Frame: 12 months ]
    Urinary symptoms using IPSS questionnaire

  6. Quality of life after prostate cancer focal therapy [ Time Frame: 12 months ]
    Quality of life based on SF-36 questionnaire evaluation

  7. Morbidity after prostate cancer focal therapy [ Time Frame: 12 months ]
    Post procedure morbidity using Clavien-Dindo classification



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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03255135


Contacts
Contact: Claudio Bovolenta Murta, MD +551131706298 cbmurta@uol.com.br
Contact: Vinicius Meneguette Golmes de Souza, MD +5511992006655 vmeneguette@gmail.com

Locations
Brazil
Hospital de Transplantes Euryclides de Jesus Zerbini Recruiting
Sao Paulo, Brazil, 01401901
Contact: Murta Claudio, MD    +5511963641196    cbmurta@uol.com.br   
Contact: Souza VInicius, MD    +5511992006655    vmeneguette@gmail.com   
Principal Investigator: Murta Claudio, MD         
Principal Investigator: Pontes Jose, PHD         
Sub-Investigator: Souza Vinicius, MD         
Sponsors and Collaborators
Hospital de Transplante Doutor Euryclides de Jesus Zerbini

Publications:

Responsible Party: Hospital de Transplante Doutor Euryclides de Jesus Zerbini
ClinicalTrials.gov Identifier: NCT03255135     History of Changes
Other Study ID Numbers: HIFU01
First Posted: August 21, 2017    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Prostatic Neoplasms
Adenocarcinoma
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type