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Publications

Journal Article Ahead of print

PubMed: 42140755 DOI: 10.1016/j.radonc.2026.111533

OLIGOPELVIS 2-GETUG P12- elective nodal radiotherapy for oligorecurrent pelvic/para-aortic nodes in prostate cancer: early toxicity of a randomized phase 3 trial.

Radiother Oncol

Authors: Hugo Corda, 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, 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, Nantes- Angers, 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, 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, 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, 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.

Abstract

PURPOSE

/objective: Limited pelvic/para-aortic nodal relapse of prostate cancer after radical local treatment remains a major challenge for locoregional salvage strategies. Salvage Elective Nodes radiotherapy (ENRT) is an appealing option, but concerns persist regarding its toxicity. This study evaluates the 18-months toxicity profile of salvage ENRT combined with intermittent androgen deprivation therapy (iADT) in patients with pelvic and para-aortic oligometastatic disease, compared with iADT alone.

MATERIAL

/Methods: OLIGOPELVIS-2/GETUG P12 was a prospective, multicenter, randomized phase III trial. Patients were randomized 1:1 to arm A (6-months iADT alone) or arm B (6-months iADT + ENRT: 54 Gy/1.8 Gy per fraction to the pelvic lymph nodes and 66 Gy/2.2 Gy per fraction to pathological nodes). ENRT started after three months of iADT. After analyzing relapse patterns in the OLIGOPELVIS GETUG P07 study, a December 22, 2021 amendment permitted the inclusion of para-aortic lymph nodes and extended irradiation fields up to the renal arteries. Toxicity was defined using NCI-CTCAE v4.0.

RESULTS

A total of 256 patients were enrolled across 17 French centers between 12/2018 and 05/2023. The safety population included 127 patients in arm A and 121 in arm B. Eight patients in arm B were excluded as they did not ultimately receive radiotherapy. Prior prostate or prostatic bed irradiation was reported in 57% and 55% of patients, respectively. In arm B, 39 patients also received para-aortic irradiation. At 6 months, grade ≥ 2 genitourinary (GU) and gastrointestinal (GI) toxicities occurred in 2.4% vs 9.9% (p = 0.02) and 0% vs 19.8% (p < 0.001) of patients in arms A and B, respectively. At 18 months, grade ≥ 2 GU toxicity was 4.1% vs 10.7%, (p = 0.04) in arms A and B, respectively, while no difference in GI toxicity was observed. Prior prostate or prostatic bed irradiation did not increase toxicity at any time point. Among patients receiving para-aortic irradiation, compared to those without : grade ≥ 2 toxicity was similar at 6 months (GU: 12.8% vs 8.5%, p = 0.8; GI: 20.5% vs 19.5%, p = 0.9), or at 18 months (GU: 10.3% vs 11%, p = 1.0; GI: 0% vs 6.1%, p = 0.17), though 6 months upper grade ≥ 1 GI disorders were more frequent (25.6% vs 9.8%, p = 0.02).

CONCLUSIONS

Eighteen-month toxicity of salvage ENRT with a simultaneous boost to the pathological lymph nodes, associated with 6-months iADT was acceptable, even among patients with prior prostate irradiation or additional para-aortic irradiation (NCT03630666- RCB 2018-A00551-54; FundingPHRC-K 16-129).

MeSH

Radiotherapy, Lymph Nodes, Neoplasms, Prostate, Lymph, Prostatic Neoplasms, Beds, Therapeutics