Clinical trial NCT05523856: New Treatment Modalities for Localized Prostate Cancer
Official title: Comparative Effectiveness of New Treatment Modalities for Localized Prostate Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
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
Impact
Comparative effectiveness research
Lead sponsor: Fundacion IMIM
Sponsor class: OTHER
Collaborators: name: Hospital Universitari de Bellvitge
name: Institut d'Investigació Biomèdica de Bellvitge
name: Hospitales Universitarios Virgen del Rocío
name: Hospital Regional Universitario Carlos Haya
name: Hospital del Mar
name: Hospital Universitario Rey Juan Carlos
name: Hospital Provincial de Castellon
name: Hospital Arnau de Vilanova
name: Hospital Universitario La Paz
name: Hospital Universitario La Fe
name: Hospital de Meixoeiro
name: Hospital Universitario 12 de Octubre
name: Hospital Universitario Reina Sofia de Cordoba
name: Hospital General Universitario de Valencia
First posted: 2022-08-31
Enrollment: 480
Sex: MALE
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with clinically localized prostate cancer.

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.

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%.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Body mass index \> 33.
* Neoadjuvant hormonal treatment.
* Previous pelvic treatments.
* Presence of serious comorbidities.

Primary outcomes:
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.
timeFrame: Baseline to 1, 3, 6, 12, 24, 60, 84, 120, 180, and 240 months after treatment
Secondary outcomes:
measure: Biochemical disease-free survival
timeFrame: 5, 7, 10, 15, and 20 years after treatment
measure: Overall survival
timeFrame: 5, 7, 10, 15, and 20 years after treatment
measure: Prostate cancer-specific survival
timeFrame: 5, 7, 10, 15, and 20 years after treatment
measure: Perceived general health measured with the 36-item Short-Form Health Survey version 2 (SF-36v2)
timeFrame: Baseline to 1, 3, 6, 12, 24, 60, 84, 120, 180, and 240 months after treatment
measure: Quality-Adjusted Life Years measured with the EuroQol-5 Dimensions
timeFrame: Baseline to 1, 3, 6, 12, 24, 60, 84, 120, 180, and 240 months after treatment
measure: Disease-specific Quality-Adjusted Life Years measured with the Patient-Oriented Prostate Utility Scale
timeFrame: Baseline to 1, 3, 6, 12, 24, 60, 84, 120, 180, and 240 months after treatment
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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).
citation: 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.
citation: 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.
citation: 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.