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Publications

Journal Article Ahead of print

PubMed: 42276876 DOI: 10.1016/j.euo.2026.04.009

Study Protocol of OLIGOPELVIS 2-GETUG P12: A Randomized Phase 3 Study Comparing Intermittent Androgen-deprivation Therapy with or Without Salvage High-dose Intensity-modulated Radiotherapy to Oligorecurrent Pelvic and Para-aortic Lymph Nodes in Patients with Biochemically Relapsing Prostate Cancer.

Eur Urol Oncol

Authors: Quentin Josset, Audrey Blanc-Lapierre, Grégoire Pigne, Lysian Cartier, David Pasquier, Philippe Ronchin, Guillaume Bera, Ali Hasbini, Benjamin Schipman, Jonathan Khalifa, Paul Sargos, Magali Quivrin, Ulrike Schick, Frédéric Mallet, Cecile Laude, Clotilde Morand, Geneviève Loos, Loig Vaugier, Ke Zhou, Nathalie Mesgouez-Nebout, Stéphane Supiot

Affiliations

  • Department of Radiation Oncology, Institut de Cancérologie de l'Ouest, Nantes, Angers, France.
  • Department of Biostatistics, Institut de Cancérologie de l'Ouest, Boulevard J. Monod, Nantes, St-Herblain, France.
  • Department of Radiation Oncology, Institut de Cancérologie de la Loire, St-Priest-en-Jarez, France.
  • Department of Radiation Oncology, Institut Sainte Catherine, Avignon, France.
  • Academic Radiation Oncology Department, Centre Oscar Lambret, Lille, France.
  • Department of Radiation Oncology, Centre Azuréen de Cancérologie, Mougins, France.
  • Department of Radiation Oncology, Centre Hospitalier (CH) Bretagne Sud, Lorient, France.
  • Department of Radiation Oncology, Clinique Pasteur, Brest, France.
  • Department of Radiation Oncology, Institut de Cancérologie de Bourgogne, Dijon, France.
  • Department of Radiation Oncology, Institut Claudius Regaud, Toulouse, France.
  • Department of Radiation Oncology, Institut Bergonie, Bordeaux, France.
  • Department of Radiation Oncology, Centre Georges François Leclerc, Dijon, France.
  • Department of Radiation Oncology, Centre Hospitalier Régional Universitaire (CHRU) Morvan, Brest, France.
  • Department of Radiation Oncology, Institut de Cancer Courlancy, Reims, France.
  • Department of Radiation Oncology, Centre Léon Bérard, Lyon, France.
  • Department of Radiation Oncology, Centre Hospitalier Départemental (CHD) Vendée, La Roche-sur-Yon, France.
  • Department of Radiation Oncology, Centre Jean Perrin, Clermont-Ferrand, France.
  • Department of Radiation Oncology, Institut de Cancérologie de l'Ouest, Nantes, Angers, France; Centre National de la Recherche Scientifique (CNRS) Unité en Sciences Biologiques et Biotechnologiques (US2B), Nantes University, Nantes, France.

Abstract

BACKGROUND

The management of oligorecurrent pelvic lymph nodes in patients with prostate cancer is debated. Intermittent androgen-deprivation therapy (ADT; IADT) is often proposed. Elective pelvis irradiation (ENRT) may prolong tumor control and decrease subsequent spread.

OBJECTIVE

To assess the efficacy of a combination of 6 mo of IADT with or without ENRT to treat patients with oligorecurrent pelvic and para-aortic lymph nodes of prostate cancer.

DESIGN, SETTING, AND PARTICIPANTS

The OLIGOPELVIS 2-GETUG P12 trial is a multicenter randomized phase 3 trial, randomizing patients with 1-5 oligorecurrent pelvic and/or para-aortic lymph nodes of prostate cancer between arm A (IADT alone for 6 mo) versus arm B (salvage pelvic image-guided intensity-modulated radiotherapy [IG-IMRT], 54 Gy, 30 fractions to the pelvis and 66 Gy, 30 fractions to the lymph nodes) combined with IADT).

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS

The primary outcome is progression-free survival, defined as the time from randomization until a biochemical-clinical failure is detected or death from any cause. In total, 256 patients will be included.

RESULTS AND LIMITATIONS

In this population of patients requiring ADT, ENRT may demonstrate antitumoral efficacy while achieving acceptable toxicity and maintaining quality of life. Limitations are mainly inherent to the open-label design of this study.

CONCLUSIONS

This phase 3 study will explore the role of salvage pelvic IG-IMRT combined with IADT in patients with oligorecurrent pelvic lymph nodes of prostate cancer in prolonging the first failure-free interval between the first and the second IADT courses.

PATIENT SUMMARY

The OLIGOPELVIS 2-GETUG P12 clinical trial assesses short-term (6 mo) androgen-deprivation therapy in association with external beam radiation therapy in men with prostate cancer relapsing to pelvic and para-aortic lymph nodes of prostate cancer. The trial investigates whether radiotherapy targeting pelvic and para-aortic lymph nodes can improve the biological response while maintaining a favorable tolerability profile.

TRIAL REGISTRATION

NCT03630666, RCB 2018-A00551-54, date of registration: 2018-12-04.

MeSH

Radiotherapy, Intensity-Modulated, Radiotherapy, Lymph Nodes, Androgens, Neoplasms, Prostate, Urologic Neoplasms, Lymph, Prostatic Neoplasms, Therapeutics