Trial Information

Effectiveness of Three Primary Treatments for Localized Prostate Cancer: Radical Prostatectomy, External-beam Radiotherapy, and Prostate Brachytherapy

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.