New Treatment Modalities for Localized Prostate Cancer

Active, not recruitingOBSERVATIONAL
Enrollment

480

Participants

Timeline

Start Date

April 30, 2014

Primary Completion Date

April 30, 2014

Study Completion Date

December 31, 2027

Conditions
Prostate Cancer
Interventions
PROCEDURE

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.

PROCEDURE

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.

RADIATION

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.

RADIATION

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%).

All Listed Sponsors
collaborator

Hospital Universitari de Bellvitge

OTHER

collaborator

Institut d'Investigació Biomèdica de Bellvitge

OTHER

collaborator

Hospitales Universitarios Virgen del Rocío

OTHER

collaborator

Hospital Regional Universitario Carlos Haya

OTHER

collaborator

Hospital del Mar

OTHER

collaborator

Hospital Universitario Rey Juan Carlos

OTHER

collaborator

Hospital Provincial de Castellon

OTHER

collaborator

Hospital Arnau de Vilanova

OTHER

collaborator

Hospital Universitario La Paz

OTHER

collaborator

Hospital Universitario La Fe

OTHER

collaborator

Hospital de Meixoeiro

OTHER_GOV

collaborator

Hospital Universitario 12 de Octubre

OTHER

collaborator

Hospital Universitario Reina Sofia de Cordoba

OTHER_GOV

collaborator

Hospital General Universitario de Valencia

OTHER

lead

Fundacion IMIM

OTHER

NCT05523856 - New Treatment Modalities for Localized Prostate Cancer | Biotech Hunter | Biotech Hunter