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.

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.