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Completed

NCT Number: NCT03790995

Functional Outcomes and QoL in Patients With High Versus Low and Intermediate Risk Prostate Cancer Treated by RARP

The Be-RALP database is Belgian prospective multicenter database governed by the Belgian cancer registry. This database investigates the status after robot assisted laparoscopic prostatectomy (RALP) in prostate cancer patients. It was established by a collaboration between the Belgian association of Urology (BAU), the National Institute for Health and Disability Insurance (NIHDI) and the Belgian cancer registry.

Between 2009 and 2016, 9235 patients were included in this patient registry.

The studied outcomes covered quality of life measures as well as variables covering urinary and erectile function.

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Key information

Conditions

Prostate Cancer Erectile Function Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Quality of Life Urinary Function Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Male

Study type

Observational

Primary location

Algemeen Stedelijk Ziekenhuis Aalst, Aalst, Belgium

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About this study

The Be-RALP database is Belgian prospective multicenter database governed by the Belgian cancer registry. This was established by a collaboration between the Belgian association of Urology (BAU), the National Institute for Health and Disability Insurance (NIHDI) and the Belgian cancer registry.

Twenty-five centres, on average 90% of all Belgian robotic centres, collected prospective data of 9235 patients from October 2009 until February 2016. These data is collected by local data managers or physicians and was required to receive reimbursion from the NIHDI for the disposables used during robot surgery. After filling in the data by the local datamanagers, the data is centralised. In Brussels the data is protected and further used by data managers and statisticians. In this system in-and output of data is strictly separated. Patient data is encoded to ensure absolute privacy. Then the data is checked upon correctness by using random checks. Data is completed where necessary.

These parameters increase the quality of data handling and database.

The final database consists of baseline pre-, per- and postoperative data as well as four standardised follow-up registrations (on 1, 3, 12 and 24 months), with follow-up data still being collected. In each follow-up registration, functional parameters and quality of life are re-assessed together with postoperative treatment status and PSA.

The Be-RALP database collected patient details of 9235 patients treated by RARP between 2009 and 2016. Patients with macro metastasis and initial PSA values higher than 100 (probable undetected micro metastasis) were excluded for this study, as well as all pT0, patients with surgery after the closing date and patients with invalid survival data. Further exclusion of patients with missing values for nerve sparing, extend of nerve sparing and risk category resulted in a group of 8306 patients.

The selected outcomes covered in the database consist of quality of life measures (European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 global, physical, emotional and cognitive) as well as variables covering urinary (Incontinence Modular Questionnaire-Urinary Incontinence: ICIQ, EORTC QLQ-PR25 urinary symptoms, incontinence aid) and erectile function (International Index of Erectile Function: IIEF, EORTC QLQ-PR25 sexual activity and sexual functioning).

A 1:1 matching between high and low-intermediate prostate cancer will be performed. Afterwards, longitudinal mixed models will quantify the relation between the explanatory variables follow-up time, risk group (high vs. low-intermediate) and postoperative treatment (postoperative radiotherapy (RT) and/or androgen deprivation therapy (ADT): yes vs. no) and the outcomes erectile- and urinary function as well as Quality of Life. All analysis will be performed using the statistical analysis software (SAS system), version 9.3.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with prostate cancer
  • Eligible to undergo RALP
  • RALP in one of the 25 participating centres

Exclusion criteria

  • iPSA > 100
  • Confirmed metastasis
  • invalid survival data
  • pT0
  • Missing nerve sparing details
  • Missing risk group

Treatment and study plan

Robot assisted laparoscopic prostatectomy

Procedure

Other names: +- postoperative treatments

Primary outcomes

  1. Global quality of life

    Time frame: Longitudinal modelling over 24 months

    EORTC C30 global quality of life, questionnaire

  2. Emotional quality of life

    Time frame: Longitudinal modelling over 24 months

    EORTC C30 emotional quality of life, questionnaire

  3. physical quality of life

    Time frame: Longitudinal modelling over 24 months

    EORTC C30 physical quality of life, questionnaire

  4. Cognitive quality of life

    Time frame: Longitudinal modelling over 24 months

    EORTC C30 cognitive quality of life, questionnaire

  5. Erectile function - IIEF 5

    Time frame: Longitudinal modelling over 24 months

    International Index of Erectile Function (IIEF-5), questionnaire

  6. Erectile function - sexual activity

    Time frame: Longitudinal modelling over 24 months

    EORTC PR25 sexual activity, questionnaire

  7. Erectile function - sexual functioning

    Time frame: Longitudinal modelling over 24 months

    EORTC PR25 sexual functioning, questionnaire

  8. Urinary function - Incontinence aid

    Time frame: Longitudinal modelling over 24 months

    EORTC PR25 incontinence aid, questionnaire

  9. Urinary function - urinary symptoms

    Time frame: Longitudinal modelling over 24 months

    EORTC PR25 urinary symptoms, questionnaire

  10. Urinary function - ICIQ

    Time frame: Longitudinal modelling over 24 months

    International Consultation on Incontinence Questionnaire

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Collaborators

  • Belgian Cancer Registry

Registry information

Official study title

Intermediate Term Functional Outcomes and Quality of Life in Patients With High Versus Low and Intermediate Risk Prostate Cancer Treated by Robot-assisted Laparoscopic Prostatectomy (RALP)

Important dates

Study start
2009
Primary completion
2016
Study completion
2018
First posted
Jan 2, 2019
Registry last updated
Jan 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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