Prostate CancerE-PROSTCaTNCT01492751
Effectiveness of Localized Prostate Cancer Treatments
An observational study of Prostate Cancer, run by Fundacion IMIM at 10 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Quality of life assessment and Clinical evaluation, Radical retropubic prostatectomy surgery and External beam radiotherapy
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 500 participants
- Where
- 10 sitesSpain
- Study dates
- Apr 2003to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with clinically localized prostate cancer.
Who may be able to join
- Stage T1 or T2, treated with radical retropubic prostatectomy, external beam radiotherapy, or interstitial brachytherapy
Who cannot join
- Previous prostate transurethral resection
- Treated in other hospitals out of the participating centers
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Spain10 sites
Centro Oncológico de Galicia
A Coruña, 15009
Fundació Puigvert
Barcelona, 08025
Hospital de La Santa Creu I Sant Pau
Barcelona, 08025
Instituto Catalán de Oncología
Hospitalet Llobregat,, Barcelona, 08908,
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Hospital Ramon Y Cajal
Madrid, 28034
Hospital Regional Carlos Haya
Málaga, 29010
Instituto Oncológico de Gipuzkoa
San Sebastián, Guipuzcoa, 20012
Capio Hospital General de Cataluña
Sant Cugat del Vallès, Barcelona, 08195
Hospitales Universitarios Virgen Del Rocío
Seville, 41013
About this study
Official title: Effectiveness of Three Primary Treatments for Localized Prostate Cancer: Radical Prostatectomy, External-beam Radiotherapy, and Prostate Brachytherapy
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Quality of life assessment and Clinical evaluation, Radical retropubic prostatectomy surgery, External beam radiotherapy, Prostate Brachytherapy
- Keywords
- Prostatic Neoplasms, Radiotherapy conformal, brachytherapy, radical prostatectomy, Quality of life, biochemical relapse, biochemical failure, survival, Clinically localized prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of life assessment and Clinical evaluationBehavioural
quality of life assessed by the Expanded Prostate Cancer Index Composite (EPIC), the Medical Outcomes Study 36-Item Short Form (SF-36) version 2, the Functional Assessment of cancer Therapy, General and Prostate specific (FACT-G and FACT-P, respectively), the International Prostate Symptom Score (IPSS), and the International Index of Erectile Function (IIES). 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.
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.
Radical retropubic prostatectomy surgeryProcedure or surgery
The surgery group underwent radical retropubic prostatectomy. The surgery is performed by a technique based on a modification of the radical retropubic prostatectomy described by Walsh. The prostatectomy is performed in retrograde way, preserving the neurovascular bundles if feasible, controlling the vessels with titanium clips, and avoiding any kind of coagulation to decrease the risk of neurovascular bundle damage. The bladder neck may be preserved on surgeon criteria. Lymph node dissection is rarely performed due to the extremely low risk of metastatic involvement in this subset of patients. The operative time is about 2 to 3 hours and required hospital stay. The patient has a urinary catheter placed for 1 to 3 weeks to facilitate bladder emptying.
External beam radiotherapyRadiation
External beam radiation is carried out with the 3D conformal technique. Patients are treated in a supine position by immobilizing feet and legs. Data from a computed tomography (CT) scan performed with the patient in the treatment position were entered into a 3D treatment-planning system to outline prostate, bladder, and rectum on each slice. Seminal vesicles and regional lymphatics are also contoured if a high risk of involvement was suspected. Applied margins are used to calculate prostate planning target volume (PTV). Custom blocking with Cerrobend blocks or multileaf collimators are designed using beam's eye view, and additional margins were adjusted to provide a minimum dose of 95% to the prostate PTV. Treatment is delivered in 1.8 to 2.0 Gy daily fractions, 5 days per week. Off-line setup control is assessed weekly by comparing orthogonal portal images with the corresponding digitally reconstructed radiographs.
Prostate BrachytherapyRadiation
Brachytherapy is performed by pre-planned procedure. Under epidural anaesthesia, the patient is placed in the lithotomy position (forced lithotomy position larger prostate volumes) and, after probing the patient, the best prostate spatial location is searched, proceeding then to prepare the sterile field and bladder catheterization. A prostate volumetry with a three-dimensional reconstruction is performed and automatically transferred to the scheduler, which processes the images and outlines the prostate, urethra and rectum in each of the sections. In LDR prostate brachytherapy, the prostate gland corresponds to the PTV. The standard dose for 100% isodose is 145 Gy according to the TG-T43 for I-125 sources. Dosimetry calculation of the automatically prescribed dosage is then estimated, with a final manual optimization.
| Study group | Role | What they receive |
|---|---|---|
| Spanish Multicentric Clinically Localized Prostate Cancer | A consecutive sample of clinically localized prostate cancer patients treated with radical prostatectomy, external beam radiotherapy and prostate brachytherapy in 10 Spanish hospitals. Receives: Behavioral: Quality of life assessment and Clinical evaluation; Procedure: Radical retropubic prostatectomy surgery; Radiation: External beam radiotherapy; Radiation: Prostate Brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: 2, 5, 7 and 10 years after treatment and every 5 years thereafter.
Secondary outcomes (10)
Biochemical disease-free survival
Number of participants who are free of biochemical relapse after a specified duration of time. Biochemical relapse is measured by PSA levels. For patients treated with radical prostatectomy, biochemical relapse criteria of the American Urological Association is applied, and for patients treated with external radiotherapy or brachytherapy, criteria of the American Society for Therapeutic Radiology and Oncology is followed.
Measured: 5, 7 and 10 years after treatment and every 5 years thereafter.
Overall survival
Number of participants who are alive after a specified duration of time. Vital status and data of death from any cause recorded by linkage with the National Institute of Statistics.
Measured: 5, 7 and 10 years after treatment and every 5 years thereafter.
Prostate cancer-specific survival
Number of participants who are not dead due to prostate cancer after a specified duration of time. Death due to prostate cancer according to the cause of death registered in the the National Institute of Statistics.
Measured: 10 years after treatment and then every 5 years thereafter.
Disease-Free Survival
Number of participants who are free of disease after a specified duration of time evaluated by digital rectal examination, biopsy, utrasonography and bone scans.
Measured: 10 years after treatment and every 5 years thereafter.
Perceived general health measured by the Medical Outcomes Study 36-Item Short Form (SF-36).
The Medical Outcomes Study 36-Item Short Form (SF-36) version 2 contains 36 items covering eight dimensions: physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems and mental health. For each dimension, a score ranges from 0-100 (higher score indicate better health).Physical and mental component summaries are constructed, using recommended scoring algorithms. Summary scores are standardized to have a mean of 50 and standard deviation of 10 in the US general population.
Measured: 2, 5, 7 and 10 years after treatment and then every 5 years thereafter.
Cancer specific Quality of Life measured by the Functional Assessment of Cancer Therapy - General and Prostate specific - (FACT-G and FACT-P, respectively).
The Functional Assessment of Cancer Therapy - General (FACT-G) version 4.0 was designed to measure Quality of Life in cancer patients. It consists of 27 items in 4 dimensions measuring Physical, Social/familial, Emotional, and Functional well-being. The Prostate module (FACT-P) is specific for patients with prostate cancer and contains 12 questions about urinary symptoms, and bowel and sexual function. Scores range from 0 to 108 on the FACT-G, and from 0 to 48 on the FACT-P, with 0 representing perfect health.
Measured: 2, 5, 7 and 10 years after treatment and every 5 years thereafter.
Urinary symptoms measured by the International Prostate Symptom Score (IPSS).
The International Prostate Symptom Score (IPSS) was developed to assess the severity of lower urinary tract symptoms associated to Benign Prostatic Hyperplasia and has also been applied to other conditions that cause LUTS. The IPSS consists of a total of seven questions that deal with voiding symptoms (incomplete empty, intermittency, weak stream and straining to void) and storage symptoms (frequency, urgency and nocturia) and an addtional question to measure quality of life. The score ranges from 0 to 35, with lower scores denoting a better health state.
Measured: 2, 5, 7 and 10 years after treatment and every 5 years thereafter.
Sexual symptoms measured by the International Index of Erectile Function (IIES).
The International Index of Erectile Function (IIES) is a 15-item, self-administered questionnaire scale for the assessment of erectile function. Scores range from 5 to 75, with higher scores denoting a better sexual function.
Measured: 2, 5, 7 and 10 years after treatment and then every 5 years thereafter.
Resource use as assessed by routine hospital and primary care data source with additional questions in clinical and participants questionnaires.
The use of services since 3 months before treatment date was obtained from care providers databases and direct costs were estimated by micro-cost calculation. Information on speciallist visits, complementary tests, emergency, hospitalization and surgery is collected for each patient.
Measured: 5, 7 and 10 years after treatment and every 5 years thereafter.
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.
The SF-6D is a utility index based on a descriptive system composed of 11 items from six dimensions of the SF-36: physical functioning, role limitations, social functioning, pain, mental functioning and vitality. It classifies individuals into 18.000 health states, of which 249 identified by a fractional factorial design were valued by a representative sample of 611 members of the UK general population. Health state values on the SF-6D are anchored to 1 (perfect health) and 0 (death), and theoretical values for health states generated by the instrument range from 1 to 0.29.
Measured: 5, 7 and 10 years after treatment and every 5 years thereafter.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2011 (estimated)
- Study startApr 2003
- Primary completionMay 2015
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion IMIM
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Montserrat Ferrer, Fundacion IMIM
- Investigators
- Montserrat Ferrer Fores, PhD, MD, Principal investigator, Fundacio IMIM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01492751
- Sponsor's protocol ID
- CaProst 2002
- Acronym
- E-PROSTCaT
- Status last verified
- Feb 2025
- First submitted
- 5 Dec 2011
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 18325680Becerra 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.
PubMed 21316126Ferrer 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.
PubMed 19211071Guedea 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.
PubMed 19574206Garin 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.
PubMed 33388360Suarez 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.
PubMed 35869124Zamora V, 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; Multicenter Spanish Group for Clinically Localized Prostate Cancer. Twenty-year Patient-reported Outcomes After Surgery, Radiotherapy, or Brachytherapy for Localized Prostate Cancer. Eur Urol Open Sci. 2025 Nov 9;82:160-167. doi: 10.1016/j.euros.2025.10.007. eCollection 2025 Dec.
PubMed 41311640
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Three Primary Treatments for Localized Prostate Cancer: Radical Prostatectomy, External-beam Radiotherapy, and Prostate Brachytherapy
- ClinicalTrials.gov ID
- NCT01492751
- Acronym / sponsor ID
- E-PROSTCaT / CaProst 2002
- Conditions
- Prostate Cancer
- Keywords
- Prostatic Neoplasms, Radiotherapy conformal, brachytherapy, radical prostatectomy, Quality of life, biochemical relapse, biochemical failure, survival
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Fundacion IMIMUniversity, hospital or other
- Study start
- Apr 2003
- Primary completion
- May 2015 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 15 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spanish Multicentric Clinically Localized Prostate Cancer | – | Behavioral: Quality of life assessment and Clinical evaluation, Procedure: Radical retropubic prostatectomy surgery, Radiation: External beam radiotherapy, Radiation: Prostate BrachytherapyA consecutive sample of clinically localized prostate cancer patients treated with radical prostatectomy, external beam radiotherapy and prostate brachytherapy in 10 Spanish hospitals. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with clinically localized prostate cancer.
Key inclusion criteria (1 listed)
- Stage T1 or T2, treated with radical retropubic prostatectomy, external beam radiotherapy, or interstitial brachytherapy
Key exclusion criteria (2 listed)
- Previous prostate transurethral resection
- Treated in other hospitals out of the participating centers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality of life assessment and Clinical evaluationquality of life assessed by the Expanded Prostate Cancer Index Composite (EPIC), the Medical Outcomes Study 36-Item Short Form (SF-36) version 2, the Functional Assessment of cancer Therapy, General and Prostate specific (FACT-G and FACT-P, respectively), the International Prostate Symptom Score (IPSS), and the International Index of Erectile Function (IIES). 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. 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. | Behavioural | Spanish Multicentric Clinically Localized Prostate Cancer |
| Radical retropubic prostatectomy surgeryThe surgery group underwent radical retropubic prostatectomy. The surgery is performed by a technique based on a modification of the radical retropubic prostatectomy described by Walsh. The prostatectomy is performed in retrograde way, preserving the neurovascular bundles if feasible, controlling the vessels with titanium clips, and avoiding any kind of coagulation to decrease the risk of neurovascular bundle damage. The bladder neck may be preserved on surgeon criteria. Lymph node dissection is rarely performed due to the extremely low risk of metastatic involvement in this subset of patients. The operative time is about 2 to 3 hours and required hospital stay. The patient has a urinary catheter placed for 1 to 3 weeks to facilitate bladder emptying. | Procedure or surgery | Spanish Multicentric Clinically Localized Prostate Cancer |
| External beam radiotherapyExternal beam radiation is carried out with the 3D conformal technique. Patients are treated in a supine position by immobilizing feet and legs. Data from a computed tomography (CT) scan performed with the patient in the treatment position were entered into a 3D treatment-planning system to outline prostate, bladder, and rectum on each slice. Seminal vesicles and regional lymphatics are also contoured if a high risk of involvement was suspected. Applied margins are used to calculate prostate planning target volume (PTV). Custom blocking with Cerrobend blocks or multileaf collimators are designed using beam's eye view, and additional margins were adjusted to provide a minimum dose of 95% to the prostate PTV. Treatment is delivered in 1.8 to 2.0 Gy daily fractions, 5 days per week. Off-line setup control is assessed weekly by comparing orthogonal portal images with the corresponding digitally reconstructed radiographs. | Radiation | Spanish Multicentric Clinically Localized Prostate Cancer |
| Prostate BrachytherapyBrachytherapy is performed by pre-planned procedure. Under epidural anaesthesia, the patient is placed in the lithotomy position (forced lithotomy position larger prostate volumes) and, after probing the patient, the best prostate spatial location is searched, proceeding then to prepare the sterile field and bladder catheterization. A prostate volumetry with a three-dimensional reconstruction is performed and automatically transferred to the scheduler, which processes the images and outlines the prostate, urethra and rectum in each of the sections. In LDR prostate brachytherapy, the prostate gland corresponds to the PTV. The standard dose for 100% isodose is 145 Gy according to the TG-T43 for I-125 sources. Dosimetry calculation of the automatically prescribed dosage is then estimated, with a final manual optimization. | Radiation | Spanish Multicentric Clinically Localized Prostate Cancer |
Primary outcome
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.
Time frame: 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.
10 secondary outcomes
Biochemical disease-free survival
Time frame: 5, 7 and 10 years after treatment and every 5 years thereafter.
Overall survival
Time frame: 5, 7 and 10 years after treatment and every 5 years thereafter.
Prostate cancer-specific survival
Time frame: 10 years after treatment and then every 5 years thereafter.
Disease-Free Survival
Time frame: 10 years after treatment and every 5 years thereafter.
Perceived general health measured by the Medical Outcomes Study 36-Item Short Form (SF-36).
Time frame: 2, 5, 7 and 10 years after treatment and then every 5 years thereafter.
Cancer specific Quality of Life measured by the Functional Assessment of Cancer Therapy - General and Prostate specific - (FACT-G and FACT-P, respectively).
Time frame: 2, 5, 7 and 10 years after treatment and every 5 years thereafter.
Urinary symptoms measured by the International Prostate Symptom Score (IPSS).
Time frame: 2, 5, 7 and 10 years after treatment and every 5 years thereafter.
Sexual symptoms measured by the International Index of Erectile Function (IIES).
Time frame: 2, 5, 7 and 10 years after treatment and then every 5 years thereafter.
Resource use as assessed by routine hospital and primary care data source with additional questions in clinical and participants questionnaires.
Time frame: 5, 7 and 10 years after treatment and every 5 years thereafter.
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.
Time frame: 5, 7 and 10 years after treatment and every 5 years thereafter.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Results publication: PubMed 18325680Ferrer 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.
- Results publication: PubMed 21316126Becerra 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.
- Results publication: PubMed 19211071Ferrer 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.
- Results publication: PubMed 19574206Guedea 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.
- Results publication: PubMed 33388360Garin 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.
- Results publication: PubMed 35869124Suarez 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.
- Derived from this study: PubMed 41311640Zamora V, 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; Multicenter Spanish Group for Clinically Localized Prostate Cancer. Twenty-year Patient-reported Outcomes After Surgery, Radiotherapy, or Brachytherapy for Localized Prostate Cancer. Eur Urol Open Sci. 2025 Nov 9;82:160-167. doi: 10.1016/j.euros.2025.10.007. eCollection 2025 Dec.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Montserrat Ferrer Fores, PhD, MD principal investigator
Fundacio IMIM
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Fundacion IMIM at 10 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 2, 5, 7 and 10 years after treatment and every 5 years thereafter.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01492751, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025; AzTrials last refreshed its copy on 7 Nov 2026.