Multicenter Study of Hypofractionated Postoperative Radiotherapy in Patients Diagnosed With Prostate Carcinoma

This is an interventional treatment trial for Prostate Cancer focused on measuring Radiotherapy, prostate cancer Read More

Inclusion Criteria:

• Age ≥ 18 years.
• ECOG 0-1 status.
• Previous radical prostatectomy (any modality will be allowed) with or without lymphadenectomy.
• Histological confirmation of prostate adenocarcinoma in the prostatectomy specimen.
• pT2-T3 Version 2.0, March 27, 2019
• pN0-Nx

• Indication of postoperative RT:

  • Adjuvant RT: pT3 and / or positive margins with PSA <0.2 ng / ml. Delayed RT is considered (> 6 months from the date of surgery but PSA <0.2 ng / ml).
  • Rescue RT: exclusive biochemical recurrence, without evidence of macroscopic local, regional or distant disease, after surgery. Biochemical recurrence is considered PSA ≥ 0.2 ng / ml after undetectable levels, confirmed with a subsequent determination.
• PSA levels ≤ 2 ng / ml after, at least 45 days after surgery and 30 days before inclusion in the study.
• No clinical evidence of lymph node disease. The presence will be admitted by imaging tests of pelvic nodes ≤ 1 cm in its shortest axis.
• No evidence of disease in the prostatic fossa. If you doubt by digital rectal examination or CT, an MRI will be performed.
• No evidence of distant disease after performing a thoraco-abdominal-pelvic CT scan and bone scan.
• Reasonable follow-up possibilities.
• Ability to complete the EPIC-26 questionnaire.
• Written informed consent prior to inclusion in the study.

Exclusion Criteria:

• - Previous pelvic radiation therapy.
• Distant metastasis.
• Macroscopic residual tumor.
• PSA> 2 ng / ml.
• Pathological stage T4.
• Lymph node involvement.
• Pelvic or para-aortic nodules in the reevaluation images after surgery, except pelvic nodes ≤ 1 cm in their shortest axis.
• Indication of pelvic nodal RT. Version 2.0, March 27, 2019
• Severe urinary incontinence at the time of indication for radiotherapy.
• Uni / bilateral hip prosthesis
• Previous tumors, except non-melanoma skin carcinoma, and which are not free of disease for at least 3 years from the end of the treatment of said neoplasms. Bladder tumors are excluded in all cases.
• Genetic hyper-radio-sensitivity syndromes.
• Chronic inflammatory bowel disease or partial or radical cystectomy for any reason.
• Previously treated with androgen deprivation therapy for a period greater than 3 months.
• Previously treated with chemotherapy for prostate cancer.
• Life expectancy <5 years or severe comorbidity: unstable angina, congestive heart failure, transmural myocardial infarction requiring admission in the last 6 months, active infectious process, respiratory disease requiring hospitalization, liver failure (Child-Pugh Class B or C), HIV with a CD4 count <200 cells / ml, kidney failure requiring dialysis and immunosuppressed by other causes.