title: OLIGOPELVIS - GETUG P07: a multicentre phase II trial of combined salvage radiotherapy and hormone therapy in oligometastatic pelvic node relapses of prostate cancer.
abstract: BACKGROUND
  Metastatic prostate cancer remains a common cause of death in Europe, and improvements in management of the disease are urgently needed. The advent of positron-emission tomography (PET) imaging enhanced with fluorocholine has led to the identification of a new sub-group of metastatic prostate cancer patients: those with so-called oligometastatic disease. Presenting with a low burden of metastatic disease (≤5 lesions), this new sub-group lies between true metastatic prostate cancer patients for whom androgen- deprivation therapy (ADT) is the mainstay of treatment, and patients with a rising PSA, but no visible lesion on conventional imaging, in whom intermittent ADT has been shown to be no less effective than continuous ADT. One might conclude that intermittent ADT would also be the standard of care for oligometastatic prostate cancer patients, but radical strategies such as extensive lymphadenectomy or high-dose radiotherapy have been suggested as another means to delay the need for ADT, and increase its effectiveness once initiated. This study will explore the role of salvage pelvic image-guided intensity-modulated radiation therapy (IMRT) combined with ADT administered for 6 months in pelvic oligometastatic patients in prolonging the failure-free interval between two consecutive ADT courses, or even to cure selected patients with limited metastatic burden.
  
  
  METHODS
  We plan to assess the two year outcome in oligometastatic prostate cancer patients (1-5 pelvic oligometastases) treated concomitantly with high-dose IMRT (54 Gy, 30 fractions to the pelvis and 66 Gy, 30 fractions to the lymph nodes) and ADT for six months.
  
  
  CONCLUSIONS
  This multicenter prospective phase II study will yield new data regarding the safety and efficacy of high-dose radiotherapy combined with ADT and will provide a basis for a larger phase III study to examine the role of radiotherapy in this population currently treated only with hormone therapy.
  
  
  BACKGROUND
  NCT02274779 , date of registration: 23/10/14.
authors.affiliation: Department of Radiation Oncology, Institut de Cancérologie de l'Ouest, Boulevard J. Monod, F-44800, Nantes, St-Herblain, France. stephane.supiot@ico.unicancer.fr.|Centre de Recherche en Cancérologie Nantes-Angers (CRCNA), UMR 892 Inserm - 6299 CNRS, Institut de Recherche en Santé de l'Université de Nantes, 8 quai Moncousu, BP 70721, 44007, Nantes cedex 1, France. stephane.supiot@ico.unicancer.fr.
authors.forename: Stephane
authors.initials: S
authors.lastname: Supiot
authors.affiliation: Department of Radiation Oncology, Institut de Cancérologie de l'Ouest, Boulevard J. Monod, F-44800, Nantes, St-Herblain, France. emmanuel.rio@ico.unicancer.fr.
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Rio
authors.affiliation: Department of Research, Institut de Cancérologie de l'Ouest-René Gauducheau, boulevard Jacques Monod, Saint Herblain, 44800, France. valerite.pacteau@ico.unicancer.fr.
authors.forename: Valérie
authors.initials: V
authors.lastname: Pacteau
authors.affiliation: Department of Research, Institut de Cancérologie de l'Ouest-René Gauducheau, boulevard Jacques Monod, Saint Herblain, 44800, France. marie-helene.mauboussin@ico.unicancer.fr.
authors.forename: Marie-Hélène
authors.initials: MH
authors.lastname: Mauboussin
authors.affiliation: Centre de Recherche en Cancérologie Nantes-Angers (CRCNA), UMR 892 Inserm - 6299 CNRS, Institut de Recherche en Santé de l'Université de Nantes, 8 quai Moncousu, BP 70721, 44007, Nantes cedex 1, France. loic.campion@ico.unicancer.fr.|Department of Statistics, Institut de Cancérologie de l'Ouest-René Gauducheau, boulevard Jacques Monod, Saint Herblain, 44800, France. loic.campion@ico.unicancer.fr.
authors.forename: Loïc
authors.initials: L
authors.lastname: Campion
authors.affiliation: Department of Research, Institut de Cancérologie de l'Ouest-René Gauducheau, boulevard Jacques Monod, Saint Herblain, 44800, France. francois.pein@ico.unicancer.fr.
authors.forename: François
authors.initials: F
authors.lastname: Pein
mesh_terms: D000368:Aged; D020249:Hormone Replacement Therapy; D006801:Humans; D008198:Lymph Nodes / Q000000981:diagnostic imaging / Q000473:pathology; D008207:Lymphatic Metastasis; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D010386:Pelvic Neoplasms / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy*; D049268:Positron-Emission Tomography; D017430:Prostate-Specific Antigen / Q000097:blood; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D011859:Radiography; D011879:Radiotherapy Dosage; D061089:Radiotherapy, Image-Guided; D016879:Salvage Therapy
chemical_list: D017430:Prostate-Specific Antigen