Effectiveness of Localized Prostate Cancer Treatments (E-PROSTCaT)

Fundacion IMIM

Status: Active, not recruiting

Conditions: Prostate Cancer

Treatments: Radiation: External beam radiotherapy; Procedure: Radical retropubic prostatectomy surgery; Behavioral: Quality of life assessment and Clinical evaluation; Radiation: Prostate Brachytherapy

Study type: Observational

Funder types: Other

Identifiers

NCT01492751

CaProst 2002

Details and patient eligibility

About

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.

Full 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:

This is a prospective observational study of a cohort with clinically localized prostate cancer treated with either radical retropubic prostatectomy, three-dimensional external-beam radiotherapy, or interstitial brachytherapy.

Participants are consecutively recruited in 10 Spanish hospital departments (located in five autonomous communities). Patients eligible for inclusion were those in stage T1 or T2, treated in one of the participating centers and without previous prostate transurethral resection. Patients are staged according to the 1992 American Joint Committee on Cancer clinical staging guidelines using a directed history and physical examination. The decision regarding treatment is made jointly by patients and health professionals.

Demographic and clinical characteristics at baseline are recorded at clinical sites and include age, Prostate Specific Antigen (PSA), Gleason grading, prostate volume, risk group and use of neoadjuvant hormonal treatment. According tho the national health guidelines participants are visited every 6-12 months after treatment.

Quality of Life questionnaires are administered centrally by telephone interview before treatment and during follow-up at 1, 3, 6, and 12 months after treatment the first year, then annually until 10 years, and every 5 years thereafter. Quality of Life evaluations are gathered using computer-assisted telephone administration and include: (1) the Expanded Prostate Cancer Index Composite (EPIC), specifically designed to measure the impact of the different treatments; (2) SF-36 Health Survey Questionnaire; (3) Functional Assessment of cancer Therapy, General and Prostate specific (FACT-G and FACT-P, respectively); (4) International Prostate Symptom Score (IPSS); and (5) International Index of Erectile Function (IIES).

A total of 120 patients was calculated to be required in each treatment group to detect between-treatment group differences of 5-points on the urinary irritative-obstructive score of the EPIC questionnaire given a standard deviation of 18.99 and a statistical power of at least 80% at a significance level of 5%, with an expected loss to follow-up of 10%. The analyst is blinded to treatment assignation.

Enrollment: 500 estimated patients

Sex: Male

Volunteers: No Healthy Volunteers

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

Trial design

500 participants in 1 patient group

Spanish Multicentric Clinically Localized Prostate Cancer

Description:

A consecutive sample of clinically localized prostate cancer patients treated with radical prostatectomy, external beam radiotherapy and prostate brachytherapy in 10 Spanish hospitals.

Treatment:

Radiation: Prostate Brachytherapy

Behavioral: Quality of life assessment and Clinical evaluation

Procedure: Radical retropubic prostatectomy surgery

Radiation: External beam radiotherapy