Clinical trial NCT01492751: Effectiveness of Localized Prostate Cancer Treatments
Official title: Effectiveness of Three Primary Treatments for Localized Prostate Cancer: Radical Prostatectomy, External-beam Radiotherapy, and Prostate Brachytherapy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Prostate Cancer
Keywords: Prostatic Neoplasms
Radiotherapy conformal
brachytherapy
radical prostatectomy
Quality of life
biochemical relapse
biochemical failure
survival
Clinically localized prostate cancer
Lead sponsor: Fundacion IMIM
Sponsor class: OTHER
First posted: 2011-12-15
Enrollment: 500
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with clinically localized prostate cancer.

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:

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 2, 5, 7 and 10 years after treatment and every 5 years thereafter.
Secondary outcomes:
measure: Biochemical disease-free survival
timeFrame: 5, 7 and 10 years after treatment and every 5 years thereafter.
measure: Overall survival
timeFrame: 5, 7 and 10 years after treatment and every 5 years thereafter.
measure: Prostate cancer-specific survival
timeFrame: 10 years after treatment and then every 5 years thereafter.
measure: Disease-Free Survival
timeFrame: 10 years after treatment and every 5 years thereafter.
measure: Perceived general health measured by the Medical Outcomes Study 36-Item Short Form (SF-36).
timeFrame: 2, 5, 7 and 10 years after treatment and then every 5 years thereafter.
measure: Cancer specific Quality of Life measured by the Functional Assessment of Cancer Therapy - General and Prostate specific - (FACT-G and FACT-P, respectively).
timeFrame: 2, 5, 7 and 10 years after treatment and every 5 years thereafter.
measure: Urinary symptoms measured by the International Prostate Symptom Score (IPSS).
timeFrame: 2, 5, 7 and 10 years after treatment and every 5 years thereafter.
measure: Sexual symptoms measured by the International Index of Erectile Function (IIES).
timeFrame: 2, 5, 7 and 10 years after treatment and then every 5 years thereafter.
measure: Resource use as assessed by routine hospital and primary care data source with additional questions in clinical and participants questionnaires.
timeFrame: 5, 7 and 10 years after treatment and every 5 years thereafter.
measure: 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.
timeFrame: 5, 7 and 10 years after treatment and every 5 years thereafter.
Other outcomes:
Locations:
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
city: Hospitalet Llobregat,
country: Spain
facility: Instituto Catalán de Oncología
state: Barcelona
city: Sant Cugat del Valles
country: Spain
facility: Capio Hospital General de Cataluña
state: Barcelona
city: San Sebastián
country: Spain
facility: Instituto Oncológico de Gipuzkoa
state: Guipuzcoa
city: A Coruña
country: Spain
facility: Centro Oncológico de Galicia
city: Barcelona
country: Spain
facility: Fundació Puigvert
city: Barcelona
country: Spain
facility: Hospital de La Santa Creu I Sant Pau
city: Madrid
country: Spain
facility: Hospital Ramon Y Cajal
city: Malaga
country: Spain
facility: Hospital Regional Carlos Haya
city: Sevilla
country: Spain
facility: Hospitales Universitarios Virgen Del Rocío
Study officials:
affiliation: Fundacio IMIM
name: Montserrat Ferrer Fores, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ferrer M, Suarez JF, Guedea F, Fernandez P, Macias V, Marino A, Hervas A, Herruzo I, Ortiz MJ, Villavicencio H, Craven-Bratle J, Garin O, Aguilo F; Multicentric Spanish Group of Clinically Localized Prostate Cancer. Health-related quality of life 2 years after treatment with radical prostatectomy, prostate brachytherapy, or external beam radiotherapy in patients with clinically localized prostate cancer. Int J Radiat Oncol Biol Phys. 2008 Oct 1;72(2):421-32. doi: 10.1016/j.ijrobp.2007.12.024. Epub 2008 Mar 5.
citation: Becerra Bachino V, Cots F, Guedea F, Pera J, Boladeras A, Aguilo F, Suarez JF, Gallo P, Murgui L, Pont A, Cunillera O, Pardo Y, Ferrer M; Grupo Multicentrico Espanol de Cancer de Prostata Organoconfinado. [Cost comparison of three treatments for localized prostate cancer in Spain: radical prostatectomy, prostate brachytherapy and external 3D conformal radiotherapy]. Gac Sanit. 2011 Jan-Feb;25(1):35-43. doi: 10.1016/j.gaceta.2010.10.008. Spanish.
citation: Ferrer M, Garin O, Pera J, Prats JM, Mendivil J, Alonso J, De Paula B, Herruzo I, Hervas A, Macias V, Marino A, Ortiz MJ, Pastor S, Ponce De Leon J, Sancho G; el Grupo Multicentrico Espanol de Cancer de Prostata Localizado. [Evaluation of the quality of life of patients with localizad prostate cancer: validation of the Spanish version of the EPIC]. Med Clin (Barc). 2009 Feb 7;132(4):128-35. doi: 10.1016/j.medcli.2008.01.001. Epub 2009 Feb 4. Spanish.
citation: Guedea F, Ferrer M, Pera J, Aguilo F, Boladeras A, Suarez JF, Cunillera O, Ferrer F, Pardo Y, Martinez E, Ventura M. Quality of life two years after radical prostatectomy, prostate brachytherapy or external beam radiotherapy for clinically localised prostate cancer: the Catalan Institute of Oncology/Bellvitge Hospital experience. Clin Transl Oncol. 2009 Jul;11(7):470-8. doi: 10.1007/s12094-009-0387-x.
citation: Garin O, Suarez JF, Guedea F, Pont A, Pardo Y, Goni A, Marino A, Hervas A, Herruzo I, Cabrera P, Sancho G, Ponce de Leon J, Macias V, Gutierrez C, Castells M, Ferrer M; Multicentric Spanish Group of Clinically Localized Prostate Cancer. Comparative Effectiveness Research in Localized Prostate Cancer: A 10-Year Follow-up Cohort Study. Int J Radiat Oncol Biol Phys. 2021 Jul 1;110(3):718-726. doi: 10.1016/j.ijrobp.2020.12.032. Epub 2021 Jan 1.
citation: Suarez JF, Zamora V, Garin O, Gutierrez C, Pont A, Pardo Y, Goni A, Marino A, Hervas A, Herruzo I, Cabrera P, Sancho G, Ponce de Leon J, Macias V, Guedea F, Vigues F, Castells M, Ferrer M; Multicentric Spanish Group of Clinically Localized Prostate Cancer. Mortality and biochemical recurrence after surgery, brachytherapy, or external radiotherapy for localized prostate cancer: a 10-year follow-up cohort study. Sci Rep. 2022 Jul 22;12(1):12589. doi: 10.1038/s41598-022-16395-w.