Single Fraction HDR Brachytherapy Plus Hypofractionated EBRT for Low-risk Prostate Cancer: Phase II Trial

OBJECTIVE The primary objective is to analyze the toxicity profile, via a phase II study of treatment of patients with low risk prostate cancer with the association of hypo fractionated EBRT and HDR brachytherapy boost. It will also analyze the biochemical control and expense to the procedure. STUDY DESIGN Prospective phase II study and not randomized. Patients with localized low-risk prostate cancer will be recruited to participate in protocol hypofractionated external beam radiotherapy followed by brachytherapy high dose rate. INCLUSION CRITERIA * Biopsy confirming adenocarcinoma of the prostate; * Low risk prostate cancer: less than or equal T2a, and less than or equal to 10 ng PSA / ml stage and Gleason score less than or equal to 6 * Prostate volume less than or equal to 60cc. EXCLUSION CRITERIA * Patients under 18 or over 90 years; * Adjuvant Hormone (any duration); * Prior pelvic radiotherapy; * Adjuvant Chemotherapy. OUTCOMES Primary outcomes: Reduction of rectal acute morbidity (within three months of treatment) and late (after three months to twelve months from the last treatment recruited patient). Reduction of acute urinary morbidity (within three months of treatment) and late (after three months to twelve months from the last treatment recruited patient). The primary outcomes (toxicity) will be evaluated in patients who receive more than 90% of the intended dose protocol with crte and HDR brachytherapy. (Scale used: CTCAE v4.03, Published online: May 28,2009 by the United States Department of Health and Human Services - NIH - attached). Secondary outcomes: Biochemical control (serial PSA measurements at intervals of three months in the first year, four months in the second year, six months of the third year onwards). Cost-analysis procedure STAGING Performing the following tests: 1. Physical examination - rectal (TR) 2. transrectal US (TRUS) 3. pelvic CT 4. serum prostatic specific antigen (PSA) dosage 5. Bone Scan ETHICAL ASPECTS The treatment regimen will be monitored for the possible emergence of excessive toxicity, considering that the same appearance in more than 25% of cases will be cause for termination of the protocol. The study will begin after approval by the Research Ethics Committee (CEP) of the AC Camargo Cancer Center. Each patient will sign a term of informed consent (IC) prior to study entry. The term was written in accessible layman's language the patient, following the ethical recommendations. Patients may withdraw from the study at any time, without prejudice to the proposed treatment. We declare the confidentiality of personally identifiable patient, it is not possible to identify it during analysis and publication of data.