480
Participants
Start Date
April 30, 2014
Primary Completion Date
April 30, 2014
Study Completion Date
December 31, 2027
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%).
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