title: The GETUG 70 Gy vs. 80 Gy randomized trial for localized prostate cancer: feasibility and acute toxicity.
abstract: OBJECTIVE
  To describe treatments and acute tolerance in a randomized trial comparing 70 Gy and 80 Gy to the prostate in patients with localized prostate cancer.
  
  
  METHODS
  Between September 1999 and February 2002, 306 patients were randomized to receive 70 Gy (153 patients) or 80 Gy (153 patients) in 17 institutions. Patients exhibited intermediate-prognosis tumors. If the risk of node involvement was greater than 10%, surgical staging was required. Previous prostatectomy was excluded, and androgen deprivation was not admitted. The treatment was delivered in two steps. PTV1-including seminal vesicles, prostate, and a 1-0.5-cm margin-received 46 Gy given with a 4-field conformal technique. PTV2, reduced to prostate with the same margins, irradiated with at least 5 fields. Dose was prescribed according to ICRU recommendations in the 70 Gy group, but adapted at the 80 Gy level.
  
  
  RESULTS
  All patients but one in the 80 Gy arm completed the treatment. In the 70 Gy arm, the mean dose to the PTV2 was 69.5 Gy. In the 80 Gy arm, the mean dose in the PTV2 was 78.5 Gy. Acute toxicity according to Radiation Therapy Oncology Group scale during treatment was reported in 306 patients. There was no statistically significant difference between the two arms: 12% had no toxicity, 80% complained of bladder toxicity, and 70% complained of rectal symptoms. Two months after the end of treatment, 43% of the 70 Gy level and 48% of the 80 Gy level complained of side effects, including 24% and 20% of sexual disorders. There was 6% and 2% of Grade 3 urinary and rectal toxicity. Five patients required a 10-29-day suspension of the treatment. Acute Grade 2 and 3 side effects were related to PTV and CTV1 size, which was the only independent predictive factor in multivariate analysis. Toxicity was not related to the center, age, arm of treatment, or selected data from dose-volume histogram of organ at risk.
  
  
  CONCLUSIONS
  Treatments were completed in respect to constraints. Acute toxicity was acceptable. Intensity of toxicity depended on target volumes.
authors.affiliation: Centre Alexis Vautrin, Vandoeuvre les Nancy, Nancy, France. v.beckendorf@nancy.fnclcc.fr
authors.forename: Véronique
authors.initials: V
authors.lastname: Beckendorf
authors.forename: Stéphane
authors.initials: S
authors.lastname: Guérif
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Le Prisé
authors.forename: Jean Marc
authors.initials: JM
authors.lastname: Cosset
authors.forename: Olivier
authors.initials: O
authors.lastname: Lefloch
authors.forename: Bruno
authors.initials: B
authors.lastname: Chauvet
authors.forename: Naji
authors.initials: N
authors.lastname: Salem
authors.forename: Olivier
authors.initials: O
authors.lastname: Chapet
authors.forename: Sylvain
authors.initials: S
authors.lastname: Bourdin
authors.forename: Jean Marc
authors.initials: JM
authors.lastname: Bachaud
authors.forename: Philippe
authors.initials: P
authors.lastname: Maingon
authors.forename: Jean-L Eon
authors.initials: JL
authors.lastname: Lagrange
authors.forename: Luc
authors.initials: L
authors.lastname: Malissard
authors.forename: Jean-Marc
authors.initials: JM
authors.lastname: Simon
authors.forename: Pascal
authors.initials: P
authors.lastname: Pommier
authors.forename: Men H
authors.initials: MH
authors.lastname: Hay
authors.forename: Bernard
authors.initials: B
authors.lastname: Dubray
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Luporsi
authors.forename: Pierre
authors.initials: P
authors.lastname: Bey
mesh_terms: D000368:Aged; D000704:Analysis of Variance; D005240:Feasibility Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011471:Prostatic Neoplasms / Q000473:pathology / Q000532:radiotherapy*; D011785:Quality Assurance, Health Care; D011879:Radiotherapy Dosage; D020266:Radiotherapy, Conformal / Q000009:adverse effects / Q000379:methods*