Oligopelvis-GETUG P07: A multicenter phase II trial of combined salvage radiotherapy and hormone therapy in oligorecurrent pelvic node relapses of prostate cancer.

Abstract

93 Background: Oligorecurrent pelvic nodal relapse of prostatic cancer is a challenge for regional salvage treatments. We conducted OLIGOPELVIS – GETUG P07, a phase II trial of combined salvage radiotherapy and hormone therapy in oligorecurrent pelvic node relapses of prostate cancer (NCT02274779). Methods: OLIGOPELVIS–GETUG P07 was a prospective multi-center phase II trial investigating high-dose salvage pelvic irradiation with an additional dose to the fluorocholine-based positron-emission-tomography (FCH- PET)-positive pelvic lymph nodes (PLN), combined with six-month androgen blockade (LH-RH agonist or antagonist injections). The prescribed dose was 54 Gy in 1.8 Gy fractions with up to 66 Gy in 2.2 Gy fractions to the pathological PLN. Toxicity (CTCAE v4) and complete response rates (PSA < 0.20 ng/ml) were analyzed. The main objective was to assess biochemical-clinical failure defined by a cluster of events including PSA progression (≥25 % and ≥ 2 ng/ml above the nadir) or clinical evidence of local or metastatic progression or post- treatment initiation of hormonal therapy or prostate cancer-related death. We hypothesized that salvage treatment would achieve a 2-year relapse-free survival of 70 %. Results: Seventy-four patients were recruited in fifteen French radiation oncology departments between August 2014 and July 2016. Seven were excluded before treatment because of violation of the inclusion criteria. The intention-to-treat analysis therefore included sixty-seven patients. Half of them had received prior prostatic/prostate bed irradiation. Median age was 67.7. Grade 2+ two-year urinary and intestinal toxicity were 10% and 2% respectively. At 2 and 3 years, 73.1 and 45.9% of patients achieved a persisting complete response respectively. After a median follow-up of 34 months, the 2-year progression-free survival rate was 77.6%. Median progression-free survival was 40.1 months. Conclusions: Combined pelvic salvage radiotherapy and hormone therapy allowed for prolonged tumor control in oligorecurrent pelvic node relapses of prostate cancer with limited toxicity. Clinical trial information: NCT02274779.

The Distribution of Pelvic Nodal Metastases in Prostate Cancer Reveals Potential to Advance and Personalize Pelvic Radiotherapy

“…analyzed patterns of nodal failure according to Morón et al. using 34 abdomino-pelvic stations ( 13 , 28 ). These circumstances can lead to possible misinterpretation of study results.…”

“…Optimal target volume design is also a pressing question in the context of nodal oligorecurrent prostate cancer, as there is a rising practice of treating nodal oligorecurrent prostate cancer with salvage lymph node dissection and/or radiotherapy ( 5 ). In retrospective case series and phase II trials, these metastasis-directed therapies have shown promising progression-free survival with limited toxicity ( 5 , 28 ). In case of radiotherapy for oligorecurrent nodal disease, current target volume concepts vary from involved node SBRT, involved site SBRT to involved field RT and elective whole pelvic RT without a clear standard having been established yet ( 4 ).…”

“…However, the already completed OLIGOPELVIS-GETUG P07 trial was able to show a limited toxicity rate (10% urinary and 2% intestinal ≥ grade 2 toxicity at 2 years). Most importantly demonstrating a 2-year progression-free survival of 77.6% the single-arm phase II OLIGOPELVIS-GETUG P07 trial also met its prespecified primary endpoint providing a clear efficacy signal for whole pelvic radiotherapy in the oligorecurrent setting ( 28 ). The results of the randomized STORM study are expected for 2024 and are eagerly awaited ( 6 ).…”

“…In the atlas of patterns of spread of prostate cancer, Barbosa et al describe a diagnostic view of lymph node regions (9). Then again, Spratt et al analyzed patterns of nodal failure according to Moroń et al using 34 abdomino-pelvic stations (13,28). These circumstances can lead to possible misinterpretation of study results.…”

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“…Optimal target volume design is also a pressing question in the context of nodal oligorecurrent prostate cancer, as there is a rising practice of treating nodal oligorecurrent prostate cancer with salvage lymph node dissection and/or radiotherapy (5). In retrospective case series and phase II trials, these metastasisdirected therapies have shown promising progression-free survival with limited toxicity (5,28). In case of radiotherapy for oligorecurrent nodal disease, current target volume concepts vary from involved node SBRT, involved site SBRT to involved field RT and elective whole pelvic RT without a clear standard having been established yet (4).…”