Prostate CancerTTOPROST/OBSNCT05523856
New Treatment Modalities for Localized Prostate Cancer
An observational study of Prostate Cancer, run by Fundacion IMIM.
Trial summary
The purpose of this study is to evaluate the effectiveness of four of the nowadays most established primary treatments for patients with clinically localized prostate cancer (active surveillance, robot-assisted radical prostatectomy, intensity-modulated radiotherapy, and real-time brachytherapy) at short-, mid- and… Read more about this study
- Who is it for?
- Ages 50 to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Active Surveillance, Robot-Assisted Radical Prostatectomy and Intensity-Modulated Radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 480 participants
- Where
- No sites listed yet
- Study dates
- Apr 2014to Dec 2027
- 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 50 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with clinically localized prostate cancer.
Who may be able to join
- Age between 50 and 75 years.
- Clinical stage T1 or T2, N0/Nx and M0/Mx.
- Gleason ≤6 or 7 (if 3+4 with T1c).
- Prostate-Specific Antigen (PSA) ≤ 10 .
- To be treated with active surveillance, robot-assisted radical prostatectomy, intensity-modulated radiotherapy or real-time brachytherapy
Who cannot join
- Body mass index > 33.
- Neoadjuvant hormonal treatment.
- Previous pelvic treatments.
- Presence of serious comorbidities.
About this study
Official title: Comparative Effectiveness of New Treatment Modalities for Localized Prostate Cancer
The purpose of this study is to evaluate the effectiveness of four of the nowadays most established primary treatments for patients with clinically localized prostate cancer (active surveillance, robot-assisted radical prostatectomy, intensity-modulated radiotherapy, and real-time brachytherapy) at short-, mid- and long-term follow-up. The primary aim is assessing the impact of treatments' side effects on patient's quality of life. As secondary objectives, biochemical disease-free survival, overall survival, and prostate cancer-specific survival will also be assessed.
Read the detailed description
Primary Objective:
To compare the impact of active surveillance, robot-assisted radical prostatectomy, intensity-modulated radiotherapy, and real-time brachytherapy in patients with localized prostate cancer, in Patient-Reported Outcome Measures, considering side effects and physical and mental health 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 mid- and 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 assess benefits and risks of the new treatment modalities for localized prostate cancer, compared with the traditional ones (open radical prostatectomy, external-beam radiotherapy and intersticial pre-planned brachytherapy).
To assess utilities with direct and indirect methods.
Outline:
This is a prospective observational study of a cohort with clinically localized prostate cancer treated with either active surveillance, robot-assisted radical prostatectomy, intensity-modulated radiotherapy, or real-time brachytherapy.
Participants are consecutively recruited in 18 Spanish hospital departments (located in six autonomous communities). Patients eligible for inclusion were: age 50-75, tumor stage T1c or T2a, N0 and M0; Gleason ≤ 6 (or 3+4 if T1c); Prostate Specific Antigen (PSA) ≤ 10 ng/mL; and to be treated with active surveillance, robot-assisted radical prostatectomy, intensity-modulated radiotherapy, or real-time brachytherapy. Patients were excluded when body mass index was >33, they had undergone neoadjuvant hormonal treatment, previous pelvic treatments, and/or had presence of serious comorbidities. 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, PSA, Gleason score, prostate volume, risk group and use of adjuvant hormonal treatment. According to the national health guidelines, participants will be visited every 6-12 months after treatment, and at least annualy thereafter.
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, and annually 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) 36-item Short-Form Health Survey version 2 (SF-36v2); (3) the EuroQol-5 Dimension (EQ-5D-5L); and (4) the Patient-Oriented Prostate Utility Scale (PORPUS).
The sample size calculated to detect small differences between groups (0.3 SD) on the EPIC or SF-36v2 scores was of 90 patients per treatment group, given a statistical power of at least 80% at a significance level of 5%, and loss to follow-up of 10%.
- Conditions
- Prostate Cancer
- Being tested
- Active Surveillance, Robot-Assisted Radical Prostatectomy, Intensity-Modulated Radiotherapy, Real-time brachytherapy
- Keywords
- Prostatic neoplasms, Active Surveillance, Robot-assisted radical prostatectomy, Intensity-Modulated Radiotherapy, Real-time brachytherapy, Health-related quality of life, Patient-Reported Outcomes, PRO, Impact, Comparative effectiveness research
- Medical subject headings
- Prostatic Neoplasms, Tooth, Impacted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active SurveillanceProcedure or surgery
It consists on monitoring the cancer with regular tests including PSA, blood test and digital rectal examination every 6 months, a magnetic resonance imaging and prostate biopsy at the first year, and based on clinical decision thereafter. If there was a change on the results, the patient is considered for treatment.
Robot-Assisted Radical ProstatectomyProcedure or surgery
It consists on the removal of the prostate gland and seminal vesicles with neurovascular preservation whenever anatomically and oncologically possible, with the Da Vinci procedure. Access is made through 5 or 6 small incisions, less than 1 cm. An extended pelvic lymph node dissection is performed when the risk estimation of node involvement is above the 5%. After surgery, the patient will be hospitalized for about 3 days and will probably resume his work activity between 3 and 5 weeks.
Intensity-Modulated RadiotherapyRadiation
Patients in this group undergo volumetric modulated arc therapy under daily image-guided radiation therapy in the supine position. Radiation is delivered in 2-3 Gy daily fractions, 5 days per week, with a prescription dose of 60-70 Gy to the prostate.
Real-time brachytherapyRadiation
Patients in this group receive I125 permanent seeds (low dose rate). The images are obtained with a transrectal ultrasound probe and are transferred to a planning system for calculating the number and position of the seeds. The prescrption dose is 145 Gy to the reference isodose (100%).
| Study group | Role | What they receive |
|---|---|---|
| New Treatment Modalities Cohort | A consecutive sample of clinically localized prostate cancer patients treated with active surveillance, robot-assisted radical prostatectomy, intensity-modulated radiotherapy, or real-time brachytherapy in 18 Spanish hospitals. Receives: Procedure: Active Surveillance; Procedure: Robot-Assisted Radical Prostatectomy; Radiation: Intensity-Modulated Radiotherapy; Radiation: Real-time brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of treatments' side effects on patients' quality of life measured in terms of change in the score of the Expanded Prostate Cancer Index Composite (EPIC) from baseline to 1, 3, 6, 12, 24, 60, 84, 120, 180, and 240 months after treatment.
The Expanded Prostate Cancer Index Composite-26 (EPIC-26) is a prostate cancer-specific questionnaire that measures urinary, sexual, bowel, and hormonal domains, ranging from 0 to 100. Response options for each EPIC item are on a 4-, 5-, or 6-level Likert scale. Items are grouped in summary scores for sexual, bowel, and hormonal domains, and in 2 scores for the urinary domain (incontinence and irritative/obstructive symptoms), which are transformed linearly to a scale from 0 to 100, where higher scores indicate better outcomes.
Measured: Baseline to 1, 3, 6, 12, 24, 60, 84, 120, 180, and 240 months after treatment
Secondary outcomes (6)
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, 10, 15, and 20 years after treatment
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, 10, 15, and 20 years after treatment
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: 5, 7, 10, 15, and 20 years after treatment
Perceived general health measured with the 36-item Short-Form Health Survey version 2 (SF-36v2)
The 36-Item Short-Form Health Survey version 2 (SF-36v2) 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: Baseline to 1, 3, 6, 12, 24, 60, 84, 120, 180, and 240 months after treatment
Quality-Adjusted Life Years measured with the EuroQol-5 Dimensions
The EuroQol-5 Dimensions (EQ-5D-5L) is a generic econometric instrument that contains five dimensions of health (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) with five levels of severity in each dimension. From the possible combinations of scales and severity levels (3125 health states), a utility index is obtained, which ranges from 1 (perfect health) to negative values, 0 being the value attributed to death.
Measured: Baseline to 1, 3, 6, 12, 24, 60, 84, 120, 180, and 240 months after treatment
Disease-specific Quality-Adjusted Life Years measured with the Patient-Oriented Prostate Utility Scale
The Patient-Oriented Prostate Utility Scale (POPRUS) is a 10-attribute health state classification system that includes 5 broad items of health-related quality of life (pain, energy, social support, communication with doctor, and emotional well-being) and 5 prostate cancer-specific items (urinary frequency and incontinence, sexual function and desire, and bowel function. A multiattribute utility function is constructed using the patient-weighted utilities elicited with standard gamble. This utility index (PORPUS-U) ranges from 1 (perfect health) to 0 (dead).
Measured: Baseline to 1, 3, 6, 12, 24, 60, 84, 120, 180, and 240 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study startApr 2014
- Primary completionApr 2014
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion IMIM
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitari de Bellvitge, Institut d'Investigació Biomèdica de Bellvitge, Hospitales Universitarios Virgen del Rocío, Hospital Regional Universitario Carlos Haya, Hospital del Mar, Hospital Universitario Rey Juan Carlos, Hospital Provincial de Castellon, Hospital Arnau de Vilanova, Hospital Universitario La Paz, Hospital Universitario La Fe, Hospital de Meixoeiro, Hospital Universitario 12 de Octubre, Hospital Universitario Reina Sofia de Cordoba, Hospital General Universitario de Valencia
- Responsible party
- Principal investigator, Montserrat Ferrer, Fundacion IMIM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05523856
- Sponsor's protocol ID
- PI15/00296
- Acronym
- TTOPROST/OBS
- Status last verified
- Mar 2025
- First submitted
- 26 Jul 2022
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data processing complies with ethical principles and relevant national and international legislation (Reglamento General de Protección de Datos 2016/679 and Organic Law 3/2018, of December 5). The final data will only be accessible to people working on the study. No data used in the analyses and subsequent dissemination of the study results will contain any identifiable reference referring to the names of patients. Once the study is finished, the results will be communicated to the competent authorities, in accordance with local legislation. Data and associated documentation will be made available to users only under a data sharing agreement that provides for: * A commitment to use the data only for research purposes and not to identify any individual participant; * A commitment to protect data through the use of appropiate information technology; * A commitment to destroy or return the data after analyses are complete.
Publications
Zamora V, Garin O, Fumadó Ll, Bonet X, Castells M, Pont A, Gutiérrez C, Ventura M, Ferrer M. Impact of the new treatment modalities in patients with localized prostate cancer. Gac Sanit 2019; 33 Suppl C:224.
Sayol L, Garin O, Pont A, Guedea F, Gutiérrez C, Ventura M, Martí-Pastor M, Ferrer M. Men undergoing active surveillance for localized prostate cancer present the best short-term quality of life outcomes. Quality of Life Research 2017;26:1-142 (206.1).
Sayol L, Garin O, Pont A, Guedea F, Gutiérrez C, Ventura M, Ferrer M. [Patients under active surveillance with localized prostate cancer are those with the best quality of life in the short-term]. Gaceta Sanitaria 2017;31 (Espec Congr):787.
Zamora V, Garin O, Pardo Y, Pont A, Gutierrez C, Cabrera P, Gomez-Veiga F, Pijoan JI, Litwin MS, Ferrer M; Multicentric Spanish Group of Clinically Localized Prostate Cancer. Mapping the Patient-Oriented Prostate Utility Scale From the Expanded Prostate Cancer Index Composite and the Short-Form Health Surveys. Value Health. 2021 Nov;24(11):1676-1685. doi: 10.1016/j.jval.2021.03.021. Epub 2021 Sep 8.
PubMed 34711369Zamora V, Garin O, Suarez JF, Gutierrez C, Guedea F, Cabrera P, Castells M, Herruzo I, Fumado L, Samper P, Ferrer C, Regis L, Pont A, Ferrer M; Multicentric Spanish Group of Clinically Localized Prostate Cancer. Comparative effectiveness of new treatment modalities for localized prostate cancer through patient-reported outcome measures. Clin Transl Radiat Oncol. 2023 Oct 29;44:100694. doi: 10.1016/j.ctro.2023.100694. eCollection 2024 Jan.
PubMed 38021091
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of New Treatment Modalities for Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT05523856
- Acronym / sponsor ID
- TTOPROST/OBS / PI15/00296
- Conditions
- Prostate Cancer
- Keywords
- Prostatic neoplasms, Active Surveillance, Robot-assisted radical prostatectomy, Intensity-Modulated Radiotherapy, Real-time brachytherapy, Health-related quality of life, Patient-Reported Outcomes, PRO
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Fundacion IMIMUniversity, hospital or other
- Collaborators
- Hospital Universitari de Bellvitge, Institut d'Investigació Biomèdica de Bellvitge, Hospitales Universitarios Virgen del Rocío, Hospital Regional Universitario Carlos Haya, Hospital del Mar, Hospital Universitario Rey Juan Carlos, Hospital Provincial de Castellon, Hospital Arnau de Vilanova, Hospital Universitario La Paz, Hospital Universitario La Fe, Hospital de Meixoeiro, Hospital Universitario 12 de Octubre, Hospital Universitario Reina Sofia de Cordoba, Hospital General Universitario de Valencia
- Study start
- Apr 2014 (actual)
- Primary completion
- Apr 2014 (actual)
- Study completion
- Dec 2027 (estimated)
- First posted
- 31 Aug 2022 (actual)
- 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 four of the nowadays most established primary treatments for patients with clinically localized prostate cancer (active surveillance, robot-assisted radical prostatectomy, intensity-modulated radiotherapy, and real-time brachytherapy) at short-, mid- and long-term follow-up. The primary aim is assessing the impact of treatments' side effects on patient's quality of life. As secondary objectives, biochemical disease-free survival, overall survival, and prostate cancer-specific survival will also be assessed.
Detailed description
Primary Objective:
To compare the impact of active surveillance, robot-assisted radical prostatectomy, intensity-modulated radiotherapy, and real-time brachytherapy in patients with localized prostate cancer, in Patient-Reported Outcome Measures, considering side effects and physical and mental health 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 mid- and 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 assess benefits and risks of the new treatment modalities for localized prostate cancer, compared with the traditional ones (open radical prostatectomy, external-beam radiotherapy and intersticial pre-planned brachytherapy).
To assess utilities with direct and indirect methods.
Outline:
This is a prospective observational study of a cohort with clinically localized prostate cancer treated with either active surveillance, robot-assisted radical prostatectomy, intensity-modulated radiotherapy, or real-time brachytherapy.
Participants are consecutively recruited in 18 Spanish hospital departments (located in six autonomous communities). Patients eligible for inclusion were: age 50-75, tumor stage T1c or T2a, N0 and M0; Gleason ≤ 6 (or 3+4 if T1c); Prostate Specific Antigen (PSA) ≤ 10 ng/mL; and to be treated with active surveillance, robot-assisted radical prostatectomy, intensity-modulated radiotherapy, or real-time brachytherapy. Patients were excluded when body mass index was >33, they had undergone neoadjuvant hormonal treatment, previous pelvic treatments, and/or had presence of serious comorbidities. 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, PSA, Gleason score, prostate volume, risk group and use of adjuvant hormonal treatment. According to the national health guidelines, participants will be visited every 6-12 months after treatment, and at least annualy thereafter.
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, and annually 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) 36-item Short-Form Health Survey version 2 (SF-36v2); (3) the EuroQol-5 Dimension (EQ-5D-5L); and (4) the Patient-Oriented Prostate Utility Scale (PORPUS).
The sample size calculated to detect small differences between groups (0.3 SD) on the EPIC or SF-36v2 scores was of 90 patients per treatment group, given a statistical power of at least 80% at a significance level of 5%, and loss to follow-up of 10%.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| New Treatment Modalities Cohort | – | Procedure: Active Surveillance, Procedure: Robot-Assisted Radical Prostatectomy, Radiation: Intensity-Modulated Radiotherapy, Radiation: Real-time brachytherapyA consecutive sample of clinically localized prostate cancer patients treated with active surveillance, robot-assisted radical prostatectomy, intensity-modulated radiotherapy, or real-time brachytherapy in 18 Spanish hospitals. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with clinically localized prostate cancer.
Key inclusion criteria (5 listed)
- Age between 50 and 75 years.
- Clinical stage T1 or T2, N0/Nx and M0/Mx.
- Gleason ≤6 or 7 (if 3+4 with T1c).
- Prostate-Specific Antigen (PSA) ≤ 10 .
- To be treated with active surveillance, robot-assisted radical prostatectomy, intensity-modulated radiotherapy or real-time brachytherapy
Key exclusion criteria (4 listed)
- Body mass index > 33.
- Neoadjuvant hormonal treatment.
- Previous pelvic treatments.
- Presence of serious comorbidities.
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 |
|---|---|---|
| Active SurveillanceIt consists on monitoring the cancer with regular tests including PSA, blood test and digital rectal examination every 6 months, a magnetic resonance imaging and prostate biopsy at the first year, and based on clinical decision thereafter. If there was a change on the results, the patient is considered for treatment. | Procedure or surgery | New Treatment Modalities Cohort |
| Robot-Assisted Radical ProstatectomyIt consists on the removal of the prostate gland and seminal vesicles with neurovascular preservation whenever anatomically and oncologically possible, with the Da Vinci procedure. Access is made through 5 or 6 small incisions, less than 1 cm. An extended pelvic lymph node dissection is performed when the risk estimation of node involvement is above the 5%. After surgery, the patient will be hospitalized for about 3 days and will probably resume his work activity between 3 and 5 weeks. | Procedure or surgery | New Treatment Modalities Cohort |
| Intensity-Modulated RadiotherapyPatients in this group undergo volumetric modulated arc therapy under daily image-guided radiation therapy in the supine position. Radiation is delivered in 2-3 Gy daily fractions, 5 days per week, with a prescription dose of 60-70 Gy to the prostate. | Radiation | New Treatment Modalities Cohort |
| Real-time brachytherapyPatients in this group receive I125 permanent seeds (low dose rate). The images are obtained with a transrectal ultrasound probe and are transferred to a planning system for calculating the number and position of the seeds. The prescrption dose is 145 Gy to the reference isodose (100%). | Radiation | New Treatment Modalities Cohort |
Primary outcome
Impact of treatments' side effects on patients' quality of life measured in terms of change in the score of the Expanded Prostate Cancer Index Composite (EPIC) from baseline to 1, 3, 6, 12, 24, 60, 84, 120, 180, and 240 months after treatment.
Time frame: Baseline to 1, 3, 6, 12, 24, 60, 84, 120, 180, and 240 months after treatment
The Expanded Prostate Cancer Index Composite-26 (EPIC-26) is a prostate cancer-specific questionnaire that measures urinary, sexual, bowel, and hormonal domains, ranging from 0 to 100. Response options for each EPIC item are on a 4-, 5-, or 6-level Likert scale. Items are grouped in summary scores for sexual, bowel, and hormonal domains, and in 2 scores for the urinary domain (incontinence and irritative/obstructive symptoms), which are transformed linearly to a scale from 0 to 100, where higher scores indicate better outcomes.
6 secondary outcomes
Biochemical disease-free survival
Time frame: 5, 7, 10, 15, and 20 years after treatment
Overall survival
Time frame: 5, 7, 10, 15, and 20 years after treatment
Prostate cancer-specific survival
Time frame: 5, 7, 10, 15, and 20 years after treatment
Perceived general health measured with the 36-item Short-Form Health Survey version 2 (SF-36v2)
Time frame: Baseline to 1, 3, 6, 12, 24, 60, 84, 120, 180, and 240 months after treatment
Quality-Adjusted Life Years measured with the EuroQol-5 Dimensions
Time frame: Baseline to 1, 3, 6, 12, 24, 60, 84, 120, 180, and 240 months after treatment
Disease-specific Quality-Adjusted Life Years measured with the Patient-Oriented Prostate Utility Scale
Time frame: Baseline to 1, 3, 6, 12, 24, 60, 84, 120, 180, and 240 months after treatment
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 12 Mar 2025.
- BackgroundZamora V, Garin O, Fumadó Ll, Bonet X, Castells M, Pont A, Gutiérrez C, Ventura M, Ferrer M. Impact of the new treatment modalities in patients with localized prostate cancer. Gac Sanit 2019; 33 Suppl C:224.
- BackgroundSayol L, Garin O, Pont A, Guedea F, Gutiérrez C, Ventura M, Martí-Pastor M, Ferrer M. Men undergoing active surveillance for localized prostate cancer present the best short-term quality of life outcomes. Quality of Life Research 2017;26:1-142 (206.1).
- BackgroundSayol L, Garin O, Pont A, Guedea F, Gutiérrez C, Ventura M, Ferrer M. [Patients under active surveillance with localized prostate cancer are those with the best quality of life in the short-term]. Gaceta Sanitaria 2017;31 (Espec Congr):787.
- Results publication: PubMed 34711369Zamora V, Garin O, Pardo Y, Pont A, Gutierrez C, Cabrera P, Gomez-Veiga F, Pijoan JI, Litwin MS, Ferrer M; Multicentric Spanish Group of Clinically Localized Prostate Cancer. Mapping the Patient-Oriented Prostate Utility Scale From the Expanded Prostate Cancer Index Composite and the Short-Form Health Surveys. Value Health. 2021 Nov;24(11):1676-1685. doi: 10.1016/j.jval.2021.03.021. Epub 2021 Sep 8.
- Results publication: PubMed 38021091Zamora V, Garin O, Suarez JF, Gutierrez C, Guedea F, Cabrera P, Castells M, Herruzo I, Fumado L, Samper P, Ferrer C, Regis L, Pont A, Ferrer M; Multicentric Spanish Group of Clinically Localized Prostate Cancer. Comparative effectiveness of new treatment modalities for localized prostate cancer through patient-reported outcome measures. Clin Transl Radiat Oncol. 2023 Oct 29;44:100694. doi: 10.1016/j.ctro.2023.100694. eCollection 2024 Jan.
- Individual participant dataSharing planned: Yes. Data processing complies with ethical principles and relevant national and international legislation (Reglamento General de Protección de Datos 2016/679 and Organic Law 3/2018, of December 5). The final data will only be accessible to people working on the study. No data used in the analyses and subsequent dissemination of the study results will contain any identifiable reference referring to the names of patients. Once the study is finished, the results will be communicated to the competent authorities, in accordance with local legislation. Data and associated documentation will be made available to users only under a data sharing agreement that provides for: * A commitment to use the data only for research purposes and not to identify any individual participant; * A commitment to protect data through the use of appropiate information technology; * A commitment to destroy or return the data after analyses are complete.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Fundacion IMIM.
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 5 inclusion and 4 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 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Impact of treatments' side effects on patients' quality of life measured in terms of change in the score of the Expanded Prostate Cancer Index Composite (EPIC) from baseline to 1, 3, 6, 12, 24, 60, 84, 120, 180, and 240 months after treatment. (time frame: Baseline to 1, 3, 6, 12, 24, 60, 84, 120, 180, and 240 months after treatment). 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 NCT05523856, which also lists 5 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 12 Mar 2025.