European urology oncology · 2026
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.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Josset Quentin, Blanc-Lapierre Audrey, Pigne Grégoire, Cartier Lysian, Pasquier David, Ronchin Philippe, Bera Guillaume, Hasbini Ali, Schipman Benjamin, Khalifa Jonathan, Sargos Paul, Quivrin Magali, Schick Ulrike, Mallet Frédéric, Laude Cecile, Morand Clotilde, Loos Geneviève, Vaugier Loig, Zhou Ke, Mesgouez-Nebout Nathalie, Supiot Stéphane
Аннотация
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.
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.