New Treatment Modalities for Localized Prostate Cancer
TTOPROST/OBS
Comparative Effectiveness of New Treatment Modalities for Localized Prostate Cancer
1 other identifier
observational
480
0 countries
N/A
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2014
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 26, 2022
CompletedFirst Posted
Study publicly available on registry
August 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
ExpectedMarch 12, 2025
March 1, 2025
Same day
July 26, 2022
March 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline to 1, 3, 6, 12, 24, 60, 84, 120, 180, and 240 months after treatment
Secondary Outcomes (6)
Biochemical disease-free survival
5, 7, 10, 15, and 20 years after treatment
Overall survival
5, 7, 10, 15, and 20 years after treatment
Prostate cancer-specific survival
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)
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
Baseline to 1, 3, 6, 12, 24, 60, 84, 120, 180, and 240 months after treatment
- +1 more secondary outcomes
Study Arms (1)
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.
Interventions
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.
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.
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.
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
Patients with clinically localized prostate cancer.
You may qualify if:
- 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
You may not qualify if:
- Body mass index \> 33.
- Neoadjuvant hormonal treatment.
- Previous pelvic treatments.
- Presence of serious comorbidities.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fundacion IMIMlead
- Hospital Universitari de Bellvitgecollaborator
- Institut d'Investigació Biomèdica de Bellvitgecollaborator
- Hospitales Universitarios Virgen del Rocíocollaborator
- Hospital Regional Universitario Carlos Hayacollaborator
- Hospital del Marcollaborator
- Hospital Universitario Rey Juan Carloscollaborator
- Hospital Provincial de Castelloncollaborator
- Hospital Arnau de Vilanovacollaborator
- Hospital Universitario La Pazcollaborator
- Hospital Universitario La Fecollaborator
- Hospital de Meixoeirocollaborator
- Hospital Universitario 12 de Octubrecollaborator
- Hospital Universitario Reina Sofia de Cordobacollaborator
- Hospital General Universitario de Valenciacollaborator
Related Publications (5)
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.
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.
BACKGROUNDZamora 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.
PMID: 34711369RESULTZamora 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.
PMID: 38021091RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor, PhD
Study Record Dates
First Submitted
July 26, 2022
First Posted
August 31, 2022
Study Start
April 1, 2014
Primary Completion
April 1, 2014
Study Completion (Estimated)
December 1, 2027
Last Updated
March 12, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- The data and definitive documentation of the project will be stored centrally on virtual servers (up to 40 TB) and research storage infrastructures provided by the Hospital del Mar Medical Research Institute, during the lifetime of the projects. Thereafter, the data will be kept for the recommended period of 20 years, as set out in the Medical Research Council's guideline "Personal Information in Medical Research" (section 7).
- Access Criteria
- Data sharing agreement among institutions.
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.