title: Intermittent versus continuous androgen deprivation therapy to biochemical recurrence after external beam radiotherapy: a phase 3 GICOR study.
abstract: OBJECTIVE
  We compared biochemical control and quality of life with intermittent (6 months) versus continuous (36 months) androgen deprivation therapy (ADT) in a non-inferiority randomized phase 3 trial in patients with biochemical failure (BF) after external beam radical radiotherapy (EBRT).
  
  
  METHODS
  Patients were stratified according to the Gleason score (GS) and were classified as low risk with a GS < 6 and 7 (3 + 4) and high risk with a GS of 7 (4 + 3) and >7. Patients were followed with PSA determinations and quality-of-life assessments (QLQ C-30 and QLQ PR-25) every 6 months for a period of 3 years. BF after radiation was defined as a PSA level of nadir +2 ng/ml. Disease progression (DP) after ADT was defined as PSA ≥4 ng/ml (BF) and/or metastases.
  
  
  RESULTS
  Seventy-seven patients were included in this multicenter phase 3 trial from 2005 to 2009. Thirty-eight and 39 patients were included in the intermittent and continuous groups, respectively. The median follow-up for both groups was 48 months (40-68). DP after ADT in the intermittent group was seen in three patients (distant metastases in one patient) versus 0 in the continuous group. The QLQ-C30 and QLQ PR-25 scores did not show any statistically difference between the two ADT groups.
  
  
  CONCLUSIONS
  No significant differences were seen in DP and QLQ between intermittent (6 months) and continuous (36 months) ADT in patients with BF after EBRT.
authors: Radiation Oncology Department, Hospital Clínic, Villarroel 170, 08036, Barcelona, Spain. fcasas@clinic.cat.
authors: F
authors: http://orcid.org/0000-0001-6464-0603
authors: F
authors: Casas
authors: Radiation Oncology Department, Hospital Sant Joan, Reus, Spain.
authors: I
authors: I
authors: Henríquez
authors: Radiation Oncology Department, Hospital Reina Sofía, Córdoba, Spain.
authors: A
authors: A
authors: Bejar
authors: Radiation Oncology Department, Hospital Vall d'Hebrón, Barcelona, Spain.
authors: X
authors: X
authors: Maldonado
authors: Radiation Oncology Department, Hospital Gregorio Marañón, Madrid, Spain.
authors: A
authors: A
authors: Alvarez
authors: Radiation Oncology Department, Hospital Gregorio Marañón, Madrid, Spain.
authors: C
authors: C
authors: González-Sansegundo
authors: Radiation Oncology Department, Duran y Reynals, Hospitalet Llobregat, Barcelona, Spain.
authors: A
authors: A
authors: Boladeras
authors: Radiation Oncology Department, Duran y Reynals, Hospitalet Llobregat, Barcelona, Spain.
authors: F
authors: F
authors: Ferrer
authors: Radiation Oncology Department, Hospital Ramón y Cajal, Madrid, Spain.
authors: A
authors: A
authors: Hervás
authors: Radiation Oncology Department, Hospital Carlos Haya, Málaga, Spain.
authors: I
authors: I
authors: Herruzo
authors: Radiation Oncology Department, Hospital Germans Trias i Pujol, Badalona, Spain.
authors: M
authors: M
authors: Caro
authors: Radiation Oncology Department, Hospital la Paz, Madrid, Spain.
authors: I
authors: I
authors: Rodriguez
authors: Radiation Oncology Department, Hospital Provincial, Castellón, Spain.
authors: C
authors: C
authors: Ferrer
mesh_terms: D000368:Aged; D000726:Androgen Antagonists / Q000627:therapeutic use*; D001918:Brachytherapy; D003131:Combined Modality Therapy; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D060787:Neoplasm Grading; D009364:Neoplasm Recurrence, Local / Q000097:blood / Q000175:diagnosis*; D009367:Neoplasm Staging; D011379:Prognosis; D011446:Prospective Studies; D017430:Prostate-Specific Antigen / Q000097:blood; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy; D011788:Quality of Life; D013997:Time Factors
chemical_list: D000726:Androgen Antagonists; D017430:Prostate-Specific Antigen
keywords: External beam radiotherapy; Intermittent androgen deprivation therapy; Prostate cancer