ACTIVE NOT RECRUITINGN/A

Effectiveness of Localized Prostate Cancer Treatments

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.

Sponsor

Fundacion IMIM

Enrollment

500 participants

Sites

10 locations

Start Date

April 2003

Completion

May 2015

Prostate CancerQuality of life assessment and Clinical evaluationRadical retropubic prostatectomy surgeryExternal beam radiotherapy

Enrollment & Timeline

Active, Not Recruiting

Target enrollment (estimated)

Target N

500

participants

Sites

locations

Duration

22.7 years

total trial span

Rate

pts/month needed

Apr 2003Month 276 of 272May 2015

100% of trial timeline elapsed

At 10 sites, each site needs to enroll approximately 0.2 patients/month to hit the enrollment target on schedule.

Enrollment target is estimated. ClinicalTrials.gov does not provide real-time enrollment progress.

View on ClinicalTrials.gov

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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.

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.

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Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Ferrer Montserrat, Suárez José Francisco, Guedea Ferran et al.International journal of radiation oncology, biology, physics2008

DOI PubMed

[Evaluation of the quality of life of patients with localizad prostate cancer: validation of the Spanish version of the EPIC].

Ferrer Montse, Garin Olatz, Pera Joan et al.Medicina clinica2009

DOI PubMed

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.

Guedea F, Ferrer M, Pera J et al.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico2009

DOI PubMed

[Cost comparison of three treatments for localized prostate cancer in Spain: radical prostatectomy, prostate brachytherapy and external 3D conformal radiotherapy].

Becerra Bachino Virginia, Cots Francesc, Guedea Ferran et al.Gaceta sanitaria2011

DOI PubMed

Comparative Effectiveness Research in Localized Prostate Cancer: A 10-Year Follow-up Cohort Study.

Garin Olatz, Suárez José Francisco, Guedea Ferran et al.International journal of radiation oncology, biology, physics2024

DOI PubMed

Mortality and biochemical recurrence after surgery, brachytherapy, or external radiotherapy for localized prostate cancer: a 10-year follow-up cohort study.

Suárez José Francisco, Zamora Víctor, Garin Olatz et al.Scientific reports2022

DOI PubMed

Twenty-year Patient-reported Outcomes After Surgery, Radiotherapy, or Brachytherapy for Localized Prostate Cancer.

Zamora Víctor, Garin Olatz, Suárez José Francisco et al.European urology open science2025

DOI PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

Ask AI

Fetching protocol from ClinicalTrials.gov…

ACTIVE NOT RECRUITINGN/A

Effectiveness of Localized Prostate Cancer Treatments

Sponsor

Fundacion IMIM

Enrollment

500 participants

Sites

10 locations

Start Date

April 2003

Completion

May 2015

Prostate CancerQuality of life assessment and Clinical evaluationRadical retropubic prostatectomy surgeryExternal beam radiotherapy

Enrollment & Timeline

Active, Not Recruiting

Target enrollment (estimated)

Target N

500

participants

Sites

locations

Duration

22.7 years

total trial span

Rate

pts/month needed

Apr 2003Month 276 of 272May 2015

100% of trial timeline elapsed

At 10 sites, each site needs to enroll approximately 0.2 patients/month to hit the enrollment target on schedule.

Enrollment target is estimated. ClinicalTrials.gov does not provide real-time enrollment progress.

View on ClinicalTrials.gov

Ask AI

Primary Outcomes

2, 5, 7 and 10 years after treatment and every 5 years thereafter.

Ask AI

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Ferrer Montserrat, Suárez José Francisco, Guedea Ferran et al.International journal of radiation oncology, biology, physics2008

DOI PubMed

[Evaluation of the quality of life of patients with localizad prostate cancer: validation of the Spanish version of the EPIC].

Ferrer Montse, Garin Olatz, Pera Joan et al.Medicina clinica2009

DOI PubMed

Guedea F, Ferrer M, Pera J et al.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico2009

DOI PubMed

[Cost comparison of three treatments for localized prostate cancer in Spain: radical prostatectomy, prostate brachytherapy and external 3D conformal radiotherapy].

Becerra Bachino Virginia, Cots Francesc, Guedea Ferran et al.Gaceta sanitaria2011

DOI PubMed

Comparative Effectiveness Research in Localized Prostate Cancer: A 10-Year Follow-up Cohort Study.

Garin Olatz, Suárez José Francisco, Guedea Ferran et al.International journal of radiation oncology, biology, physics2024

DOI PubMed

Mortality and biochemical recurrence after surgery, brachytherapy, or external radiotherapy for localized prostate cancer: a 10-year follow-up cohort study.

Suárez José Francisco, Zamora Víctor, Garin Olatz et al.Scientific reports2022

DOI PubMed

Twenty-year Patient-reported Outcomes After Surgery, Radiotherapy, or Brachytherapy for Localized Prostate Cancer.

Zamora Víctor, Garin Olatz, Suárez José Francisco et al.European urology open science2025

DOI PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

Ask AI

Effectiveness of Localized Prostate Cancer Treatments

Enrollment & Timeline

Primary Outcomes

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Effectiveness of Localized Prostate Cancer Treatments

Enrollment & Timeline

Primary Outcomes

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Eligibility

Trial Sites (10)