Trial Title:
New Treatment Modalities for Localized Prostate Cancer
NCT ID:
NCT05523856
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: 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
Study type:
Observational
Overall status:
Active, not recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Active Surveillance
Description:
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.
Arm group label:
New Treatment Modalities Cohort
Intervention type:
Procedure
Intervention name:
Robot-Assisted Radical Prostatectomy
Description:
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.
Arm group label:
New Treatment Modalities Cohort
Intervention type:
Radiation
Intervention name:
Intensity-Modulated Radiotherapy
Description:
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.
Arm group label:
New Treatment Modalities Cohort
Intervention type:
Radiation
Intervention name:
Real-time brachytherapy
Description:
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%).
Arm group label:
New Treatment Modalities Cohort
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%.
Criteria for eligibility:
Study pop:
Patients with clinically localized prostate cancer.
Sampling method:
Non-Probability Sample
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.
Gender:
Male
Minimum age:
50 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
April 2014
Completion date:
December 2027
Lead sponsor:
Agency:
Fundacion IMIM
Agency class:
Other
Collaborator:
Agency:
Hospital Universitari de Bellvitge
Agency class:
Other
Collaborator:
Agency:
Institut d'Investigació Biomèdica de Bellvitge
Agency class:
Other
Collaborator:
Agency:
Hospitales Universitarios Virgen del Rocío
Agency class:
Other
Collaborator:
Agency:
Hospital Regional Universitario Carlos Haya
Agency class:
Other
Collaborator:
Agency:
Hospital del Mar
Agency class:
Other
Collaborator:
Agency:
Hospital Universitario Rey Juan Carlos
Agency class:
Other
Collaborator:
Agency:
Hospital Provincial de Castellon
Agency class:
Other
Collaborator:
Agency:
Hospital Arnau de Vilanova
Agency class:
Other
Collaborator:
Agency:
Hospital Universitario La Paz
Agency class:
Other
Collaborator:
Agency:
Hospital Universitario La Fe
Agency class:
Other
Collaborator:
Agency:
Hospital de Meixoeiro
Agency class:
Other
Collaborator:
Agency:
Hospital Universitario 12 de Octubre
Agency class:
Other
Collaborator:
Agency:
Hospital Universitario Reina Sofia de Cordoba
Agency class:
Other
Collaborator:
Agency:
Hospital General Universitario de Valencia
Agency class:
Other
Source:
Fundacion IMIM
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05523856