Effectiveness of Three Primary Treatments for Localized Prostate Cancer: Radical Prostatectomy, External-beam Radiotherapy, and Prostate Brachytherapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 500
- Locations
- 10
- Primary Endpoint
- Quality of Life impact of treatments' side effects measured by change in the Expanded Prostate Cancer Index Composite (EPIC) score from baseline to 2, 5, 7 and 10 years after treatment and every 5 years thereafter.
Study Overview
Brief Summary
The purpose of this study is to evaluate the effectiveness of the three most established primary treatments for patients with clinically localized prostate cancer (radical prostatectomy, external-beam radiotherapy, and prostate brachytherapy) at short, mid and long-term follow-up. The primary aim is assessing Quality of Life impact of treatments' side effects. As secondary objectives biochemical disease-free survival, overall survival, and prostate cancer-specific survival will be also assessed.
Detailed Description
Primary Objective:
To assess the Quality of Life impact of treatments' side effects (radical prostatectomy, external beam radiotherapy and prostate brachytherapy) on patients with localized prostate cancer at short, mid and long-term follow-up.
Secondary Objectives:
- To assess biochemical disease-free survival by treatment and risk group, at mid and long-term follow-up.
- To assess overall survival by treatment and risk group, at mid and long-term follow-up.
- To assess prostate cancer-specific survival by treatment and risk group, at long-term follow-up.
- To assess disease-free survival by treatment and risk group, at long-term follow-up.
- To assess perceived general health and cancer-specific quality of life by treatment and risk group, at short, mid and long-term follow-up.
- To calculate the resource use and cost of the three primary treatments.
- To assess preferences with direct and indirect methods.
Outline:
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Stage T1 or T2, treated with radical retropubic prostatectomy, external beam radiotherapy, or interstitial brachytherapy
Exclusion Criteria
- •Previous prostate transurethral resection
- •Treated in other hospitals out of the participating centers
Outcomes
Primary Outcomes
Quality of Life impact of treatments' side effects measured by change in the Expanded Prostate Cancer Index Composite (EPIC) score from baseline to 2, 5, 7 and 10 years after treatment and every 5 years thereafter.
Time Frame: 2, 5, 7 and 10 years after treatment and every 5 years thereafter.
The Expanded Prostate Cancer Index Composite (EPIC) is a prostate cancer specific questionnaire constructed by expanding the UCLA-PCI to assess function and bother in the 4 domains: Urinary, Bowel, Sexual, and Hormonal.For each domain a summary score is constructed. In addition, two urinary scales that distinguish irritative/obstructive symptoms and incontinence are developed by the authors of the questionnaire. The 50 EPIC items are answered on a 5-point Likert scale and these are transformed linearly to obtain scores ranging from 0-100, with higher scores indicating better Quality of Life.
Secondary Outcomes
- Urinary symptoms measured by the International Prostate Symptom Score (IPSS).(2, 5, 7 and 10 years after treatment and every 5 years thereafter.)
- Resource use as assessed by routine hospital and primary care data source with additional questions in clinical and participants questionnaires.(5, 7 and 10 years after treatment and every 5 years thereafter.)
- Utilities measured by the Short Form-6D (SF-6D), a subset of the SF-36, and additional questions to estimate preferences by time-trade off, standard gamble and willingness to pay.(5, 7 and 10 years after treatment and every 5 years thereafter.)
- Biochemical disease-free survival(5, 7 and 10 years after treatment and every 5 years thereafter.)
- Overall survival(5, 7 and 10 years after treatment and every 5 years thereafter.)
- Perceived general health measured by the Medical Outcomes Study 36-Item Short Form (SF-36).(2, 5, 7 and 10 years after treatment and then every 5 years thereafter.)
- Prostate cancer-specific survival(10 years after treatment and then every 5 years thereafter.)
- Disease-Free Survival(10 years after treatment and every 5 years thereafter.)
- Cancer specific Quality of Life measured by the Functional Assessment of Cancer Therapy - General and Prostate specific - (FACT-G and FACT-P, respectively).(2, 5, 7 and 10 years after treatment and every 5 years thereafter.)
- Sexual symptoms measured by the International Index of Erectile Function (IIES).(2, 5, 7 and 10 years after treatment and then every 5 years thereafter.)
Investigators
Montserrat Ferrer
MD
Fundacion IMIM