Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
480 participants
OBSERVATIONAL
2014-04-30
2027-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Active Surveillance
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 Prostatectomy
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 Radiotherapy
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 brachytherapy
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%).
Interventions
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Active Surveillance
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 Prostatectomy
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 Radiotherapy
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 brachytherapy
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%).
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Neoadjuvant hormonal treatment.
* Previous pelvic treatments.
* Presence of serious comorbidities.
50 Years
75 Years
MALE
No
Sponsors
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Hospital Universitari de Bellvitge
OTHER
Institut d'Investigació Biomèdica de Bellvitge
OTHER
Hospitales Universitarios Virgen del Rocío
OTHER
Hospital Regional Universitario Carlos Haya
OTHER
Hospital del Mar
OTHER
Hospital Universitario Rey Juan Carlos
OTHER
Hospital Provincial de Castellon
OTHER
Hospital Arnau de Vilanova
OTHER
Hospital Universitario La Paz
OTHER
Hospital Universitario La Fe
OTHER
Hospital de Meixoeiro
OTHER_GOV
Hospital Universitario 12 de Octubre
OTHER
Hospital Universitario Reina Sofia de Cordoba
OTHER_GOV
Hospital General Universitario de Valencia
OTHER
Fundacion IMIM
OTHER
Responsible Party
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Montserrat Ferrer
Medical Doctor, PhD
References
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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.
Zamora 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.
Other Identifiers
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PI15/00296
Identifier Type: -
Identifier Source: org_study_id
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