Clinical trial · Observational
Effectiveness of Localized Prostate Cancer Treatments
Effectiveness of Three Primary Treatments for Localized Prostate Cancer: Radical Prostatectomy, External-beam Radiotherapy, and Prostate Brachytherapy
NCT01492751CI-TRIAL-00086608E-PROSTCaTactive not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| External beam radiotherapy | Radiation | — | UNRESOLVED |
| Prostate Brachytherapy | Radiation | — | UNRESOLVED |
| Quality of life assessment and Clinical evaluation | Behavioral | — | UNRESOLVED |
| Radical retropubic prostatectomy surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 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.
- interventionNames
- Behavioral: Quality of life assessment and Clinical evaluation
- Procedure: Radical retropubic prostatectomy surgery
- Radiation: External beam radiotherapy
- Radiation: Prostate Brachytherapy
Primary outcomes (1)
- 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.
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
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
References
Publications (7)
- RESULTFerrer 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. PMID 18325680
- RESULTBecerra 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. PMID 21316126
- RESULTFerrer 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. PMID 19211071
- RESULTGuedea 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. PMID 19574206
- RESULTGarin 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.