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Study Protocol of OLIGOPELVIS 2-GETUG P12: A Randomized Phase 3 Study Comparing Intermittent Androgen-deprivation
Quentin Josset1, Audrey Blanc-Lapierre2, Grégoire Pigne3
1Department of Radiation Oncology, Institut de Cancérologie de l'Ouest, Nantes, Angers, France.
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.
