Short-term androgen deprivation therapy combined with radiotherapy as salvage treatment after radical prostatectomy for prostate cancer (GETUG-AFU 16): a 112-month follow-up of a phase 3, randomised trial

Carrié, C.; Magné, Nicolas; Burban-Provost, Patricia; Sargos, P.; Latorzeff, I.; Lagrange, Jean‐Léon; Supiot, S.; Belkacémi, Yazid; Peiffert, D.; Allouache, N.; Dubray, Bernard; Servagi-Vernat, S.; Suchaud, Jean-Philippe; Créhange, G.; Guérif, S.; Brihoum, Meryem; Barbier, Nicolas; Graff-Cailleaud, Pierre; Ruffion, A.; Dussart, Sophie; Ferlay, Céline; Chabaud, Sylvie

doi:10.1016/s1470-2045(19)30486-3

Cited by 174 publications

(151 citation statements)

References 30 publications

(20 reference statements)

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“…In both arms, short term ADT will be mandatory. The rationale for the use of temporary ADT is extrapolated from the data in the salvage setting (GETUG16, RTOG9601, SPPORT, OLIGOPELVIS), indicating that temporary ADT reduces the rate of biochemical and clinical recurrences [12,18,19,42,43]. There are no clear guidelines on the ideal duration of ADT in this setting, so we opted for 6 months as studied in GETUG16, OLIGOPELVIS and SPPORT [19,42,43].…”

Section: Discussionmentioning

confidence: 99%

“…The proposed trial randomizes patients with oligorecurrent nodal PCa following primary PCa treatment to either MDT (sLND or SBRT) or WPRT plus MDT (focal radiotherapy boost or sLND). As two recent trials have suggested a progression-free and even overall survival benefit by adding temporary ADT to local therapy in case of biochemical recurrence [18,19], a positive effect could also be expected for regional recurrence. Although the optimal duration of ADT is unknown, a minimal duration of 6 months of ADT seems advisable in this setting and is mandatory for both arms.…”

Section: Introductionmentioning

confidence: 99%

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PEACE V – Salvage Treatment of OligoRecurrent nodal prostate cancer Metastases (STORM): a study protocol for a randomized controlled phase II trial

et al. 2020

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Background: Pelvic nodal recurrences are being increasingly diagnosed with the introduction of new molecular imaging techniques, like choline and PSMA PET-CT, in the restaging of recurrent prostate cancer (PCa). At this moment, there are no specific treatment recommendations for patients with limited nodal recurrences and different locoregional treatment approaches are currently being used, mostly by means of metastasis-directed therapies (MDT): salvage lymph node dissection (sLND) or stereotactic body radiotherapy (SBRT). Since the majority of patients treated with MDT relapse within 2 years in adjacent lymph node regions, with an estimated median time to progression of 12-18 months, combining MDT with whole pelvic radiotherapy (WPRT) may improve oncological outcomes in these patients. The aim of this prospective multicentre randomized controlled phase II trial is to assess the impact of the addition of WPRT to MDT and short-term androgen deprivation therapy (ADT) on metastasis-free survival (MFS) in the setting of oligorecurrent pelvic nodal recurrence. Methods & design: Patients diagnosed with PET-detected pelvic nodal oligorecurrence (≤5 nodes) following radical local treatment for PCa, will be randomized in a 1:1 ratio between arm A: MDT and 6 months of ADT, or arm B: WPRT added to MDT and 6 months of ADT. Patients will be stratified by type of PET-tracer (choline, FACBC or PSMA) and by type of MDT (sLND or SBRT). The primary endpoint is MFS and the secondary endpoints include clinical and biochemical progression-free survival (PFS), prostate cancer specific survival, quality of life (QoL), toxicity and time to castration-resistant prostate cancer (CRPC) and to palliative ADT. Estimated study completion: December 31, 2023.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

PEACE V – Salvage Treatment of OligoRecurrent nodal prostate cancer Metastases (STORM): a study protocol for a randomized controlled phase II trial

et al. 2020

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“…The evidence provided by large prospective studies [18][19][20] recently supported the choice to associate the SRT with HT, but recent analyses of long-term data seems to highlight an increase in toxicity from associated therapy, with negative effects on overall survival. 21 We are aware that the numerical data that support our evaluation are limited and that the conclusions provided need further clinical validation through prospective studies on large numbers of patients.…”

Section: Discussionmentioning

confidence: 99%

“…Three randomized trials 18‐20 have shown an improvement in post‐SRT biochemical failure (post‐SRTBF) by associating hormone therapy (HT), but a recent interim analysis of the RTOG 9601 trial 21 has shown that the advantage in biochemical disease free survival (BDFS) with the addition of HT is largely outweighed by the risk of death from other causes, with an overall survival (OS) reduction in HT patients.…”

Section: Introductionmentioning

confidence: 99%

“…6,8,15 In order to select patients with higher probabilities of biochemical control following SRT are used predictive nomograms, dependent on the Gleason Score value, preoperative and postoperative PSA values, Psa Doubling Time (PSADT) and state of surgical margins. 10,16,17 Three randomized trials [18][19][20] have shown an improvement in post-SRT biochemical failure (post-SRTBF) by associating hormone therapy (HT), but a recent interim analysis of the RTOG 9601 trial 21 has shown that the advantage in biochemical disease free survival (BDFS) with the addition of HT is largely outweighed by the risk of death from other causes, with an overall survival (OS) reduction in HT patients.…”

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confidence: 99%

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Predictive value of Prostate Specific Antigen variations in the last week of salvage radiotherapy for biochemical recurrence of prostate cancer after surgery: A practical approach

et al. 2020

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Background: About a third of patients who underwent radical prostatectomy for prostate cancer (Pca) develop a biochemical failure (BF) within 10 years from surgery, and about a half of them receive salvage radiation therapy (SRT). Factors to predict risk to relapse after SRT are still lacking. Dynamic models, based on the assessment of changes in Prostate Specific Antigen (PSA) postsurgery seem to show good reliability. Aims: The goal of the study was to identify a simple analytical method for the postsalvage radiation therapy biochemical failure (post-SRTBF) prediction before the end of the SRT, regardless of the PSA value at the beginning of the treatment (PSA start), measuring the PSA values at the start and 1 week before the end of SRT. Methods: In a series of 83 patients treated with SRT for BF of Pca we measured PSA values at the first day and 1 week before the end of SRT. These values were used to define an analytical method for the post-SRTBF prediction. Results: PSA value in patients without post-SRTBF show a significant difference in term of difference during the SRT with respect to patients with post-SRTBF. Starting from this difference, we identified a simple and practical analytical method for the post-SRTBF prediction before the end of the SRT. The data corresponds with the model and the analytical method is highly predictive (Sensitivity = 81%, Specificity = 85%, Accuracy = 83%). Conclusion: This study offers a new tool to early predict Pca relapse overtime and to select patients who can benefit from an early additional systemic treatment.

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Comparison of Multimodal Therapies and Outcomes Among Patients With High-Risk Prostate Cancer With Adverse Clinicopathologic Features

et al. 2021

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IMPORTANCE The optimal management strategy for high-risk prostate cancer and additional adverse clinicopathologic features remains unknown. OBJECTIVE To compare clinical outcomes among patients with high-risk prostate cancer after definitive treatment. DESIGN, SETTING, AND PARTICIPANTS This retrospective cohort study included patients with high-risk prostate cancer (as defined by the National Comprehensive Cancer Network [NCCN]) and at least 1 adverse clinicopathologic feature (defined as any primary Gleason pattern 5 on biopsy, clinical T3b-4 disease, Ն50% cores with biopsy results positive for prostate cancer, or NCCN Ն2 high-risk features) treated between 2000 and 2014 at 16 tertiary centers. Data were analyzed in November 2020.EXPOSURES Radical prostatectomy (RP), external beam radiotherapy (EBRT) with androgen deprivation therapy (ADT), or EBRT plus brachytherapy boost (BT) with ADT. Guideline-concordant multimodal treatment was defined as RP with appropriate use of multimodal therapy (optimal RP), EBRT with at least 2 years of ADT (optimal EBRT), or EBRT with BT with at least 1 year ADT (optimal EBRT with BT). MAIN OUTCOMES AND MEASURESThe primary outcome was prostate cancer-specific mortality; distant metastasis was a secondary outcome. Differences were evaluated using inverse probability of treatment weight-adjusted Fine-Gray competing risk regression models. RESULTS A total of 6004 men (median [interquartile range] age, 66.4 [60.9-71.8] years) with highrisk prostate cancer were analyzed, including 3175 patients (52.9%) who underwent RP, 1830 patients (30.5%) who underwent EBRT alone, and 999 patients (16.6%) who underwent EBRT with BT. Compared with RP, treatment with EBRT with BT (subdistribution hazard ratio [sHR] 0.78, [95%CI, 0.63-0.97]; P = .03) or with EBRT alone (sHR, 0.70 [95% CI, 0.53-0.92]; P = .01) was associated with significantly improved prostate cancer-specific mortality; there was no difference in prostate cancer-specific mortality between EBRT with BT and EBRT alone (sHR, 0.89 [95% CI, 0.67-1.18]; P = .43). No significant differences in prostate cancer-specific mortality were found across treatment cohorts among 2940 patients who received guideline-concordant multimodality treatment (eg, (continued) Key Points Question Are external beam radiotherapy, with or without brachytherapy boost, or radical prostatectomy associated with differences in prostate cancer-specific mortality or distant metastasis outcomes in patients with high-risk prostate cancer after accounting for delivery of guideline-concordant multimodality therapy? Findings In this cohort study of 6004 men with high-risk prostate cancer and at least 1 additional adverse clinicopathologic feature, no differences in prostate cancer-specific mortality across treatment modalities were identified among patients who received guideline-concordant multimodality therapy, although differences in time to metastasis were observed. However, significant differences in prostate cancer-specific mortality were identified when guideline-concordan...

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Short-term androgen deprivation therapy combined with radiotherapy as salvage treatment after radical prostatectomy for prostate cancer (GETUG-AFU 16): a 112-month follow-up of a phase 3, randomised trial

Cited by 174 publications

References 30 publications

PEACE V – Salvage Treatment of OligoRecurrent nodal prostate cancer Metastases (STORM): a study protocol for a randomized controlled phase II trial

PEACE V – Salvage Treatment of OligoRecurrent nodal prostate cancer Metastases (STORM): a study protocol for a randomized controlled phase II trial

Predictive value of Prostate Specific Antigen variations in the last week of salvage radiotherapy for biochemical recurrence of prostate cancer after surgery: A practical approach

Comparison of Multimodal Therapies and Outcomes Among Patients With High-Risk Prostate Cancer With Adverse Clinicopathologic Features

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