A Phase III Multi-Centre Randomised Trial comparing adjuvant versus early salvage Radiotherapy following a Radical Prostatectomy: Results of the TROG 08.03 and ANZUP “RAVES” Trial

Kneebone, Andrew; Fraser-Browne, Carol; Delprado, Warwick; Duchesne, Gillian; Fisher, Richard; Frydenberg, Mark; Haworth, Annette; Herschtal, Alan; Joseph, David; Lim, Tee; Martin, Jarad; Millar, Jeremy; Sidhom, Mark; Spry, Nigel; Tang, Colin; Turner, Susan; Williams, Scott; Wiltshire, K.; Woo, Henry H.; Pearse, Maria

doi:10.1016/j.ijrobp.2019.06.456

Cited by 40 publications

(34 citation statements)

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“…Such selection is paramount, especially when considering the results of Phase 3 studies comparing early salvage radiotherapy and adjuvant radiotherapy. Preliminary results from RADICALS-RT, GETUG-AFU 17, RAVES, and their meta-analysis (ARTISTIC) [8][9][10] suggested that eSRT was not significantly different from aRT, thereby favoring the use of eSRT instead of aRT.…”

Section: Discussionmentioning

confidence: 99%

“…Adjuvant radiotherapy (aRT) improves BCR-free survival, but its impact on overall survival is controversial and was shown to increase gastrointestinal and genitourinary side effects [4][5][6][7]. Hence, aRT was recently challenged by early salvage radiotherapy (esRT) with no significant benefit emerging for the use of aRT for BCR-free survival, thus highlighting the need for additional biomarkers to enable patient selection [8][9][10].…”

Section: Introductionmentioning

confidence: 99%

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External Validation of an MRI-Derived Radiomics Model to Predict Biochemical Recurrence after Surgery for High-Risk Prostate Cancer

Bourbonne

Fournier

Vallières

et al. 2020

Cancers

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Adjuvant radiotherapy after prostatectomy was recently challenged by early salvage radiotherapy, which highlighted the need for biomarkers to improve risk stratification. Therefore, we developed an MRI ADC map-derived radiomics model to predict biochemical recurrence (BCR) and BCR-free survival (bRFS) after surgery. Our goal in this work was to externally validate this radiomics-based prediction model. Experimental Design: A total of 195 patients with a high recurrence risk of prostate cancer (pT3-4 and/or R1 and/or Gleason’s score > 7) were retrospectively included in two institutions. Patients with postoperative PSA (Prostate Specific Antigen) > 0.04 ng/mL or lymph node involvement were excluded. Radiomics features were extracted from T2 and ADC delineated tumors. A total of 107 patients from Institution 1 were used to retrain the previously published model. The retrained model was then applied to 88 patients from Institution 2 for external validation. BCR predictions were evaluated using AUC (Area Under the Curve), accuracy, and bRFS using Kaplan–Meier curves. Results: With a median follow-up of 46.3 months, 52/195 patients experienced BCR. In the retraining cohort, the clinical prediction model (combining the number of risk factors and postoperative PSA) demonstrated moderate predictive power (accuracy of 63%). The radiomics model (ADC-based SZEGLSZM) predicted BCR with an accuracy of 78% and allowed for significant stratification of patients for bRFS (p < 0.0001). In Institution 2, this radiomics model remained predictive of BCR (accuracy of 0.76%) contrary to the clinical model (accuracy of 0.56%). Conclusions: The recently developed MRI ADC map-based radiomics model was validated in terms of its predictive accuracy of BCR and bRFS after prostatectomy in an external cohort.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

External Validation of an MRI-Derived Radiomics Model to Predict Biochemical Recurrence after Surgery for High-Risk Prostate Cancer

Bourbonne

Fournier

Vallières

et al. 2020

Cancers

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“…Immintely reporting phase III clinical trials will address some of the uncertainties facing the management of the post-prostatectomy patients. The presented RAVES and RADICALS trials as well as the ARTISTIC meta-analysis suggest that salvage radiotherapy is of similar benefit to adjuvant radiotherapy, limiting the number of patients we may consider for adjuvant radiotherapy among patients with high-risk features for recurrence (30)(31)(32). GETUG-AFU 17 investigates a broader spectrum of patients at a greater risk for recurrence and compares adjuvant vs. early salvage radiotherapy, both combined with concurrent ST-ADT (20).…”

Section: Discussionmentioning

confidence: 99%

Combined Long-Term Androgen Deprivation and Pelvic Radiotherapy in the Post-operative Management of Pathologically Defined High-Risk Prostate Cancer Patients: Results of the Prospective Phase II McGill 0913 Study

et al. 2020

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Following radical prostatectomy, prostate bed radiotherapy (PBRT) has been combined with either long-term androgen deprivation therapy (LT-ADT) or short-term ADT with pelvic lymph node radiotherapy (PLNRT) to provide an oncological benefit in randomized trials. McGill 0913 was designed to characterize the efficacy of combining PBRT, PLNRT, and LT-ADT. It is the first study to do so prospectively. Methods: In a single arm phase II trial conduced from 2010 to 2016, 46 post-prostatectomy prostate cancer patients at a high-risk for relapse (pathological Gleason 8+ or T3) were assessed for treatment with combined LT-ADT (24 months), PBRT, and PLNRT. Patients received PLNRT and PBRT (44 Gy in 22 fractions) followed by a PBRT boost (22 Gy in 11 fractions). The primary endpoint was progression-free survival (PFS). Toxicity and quality of life (QoL) were evaluated using CTCAE V3.0 and EQ-5D-3L questionnaires, respectively. Results: Among the 43 patients were treated as per protocol, median PSA was 0.30 µg/L. On surgical pathology, 51% had positive margins, 40% had Gleason 8+ disease, 42% had seminal vesicle involvement, and 19% had lymph node involvement. At a median follow-up of 5.2 years, there were no deaths or clinical progression. At 5 years, PFS was 78.0% (95% Confidence Interval 63.7-95.5%). Not including erectile dysfunction, patients experienced: 14% grade 2 endocrine toxicity while on ADT, one incident of long-term gynecomastia, 5% grade 2 acute urinary toxicity, 5% grade 2 late Kucharczyk et al. McGill 0913: Pelvic Radiotherapy and LT-ADT Urinary toxicity, and 24% long-term hypogonadism. No comparison between the average or minimum self-reported QoL at baseline, during ADT, nor after ADT demonstrated a statistically significant difference. Conclusions: Combining PBRT, PLNRT, and LT-ADT had an acceptable PFS in patients with significant post-operative risk factors for recurrence. While therapy was well-tolerated, long-term hypogonadism was a substantial risk. Further investigations are needed to determine if this combination is beneficial. Trial registration: NCT01255891.

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“…It was agreed, based on recently presented evidence from Radiotherapy—Adjuvant Versus Early Salvage trial 13 and Radiation Therapy and Androgen Deprivation Therapy in Treating Patients Who Have Undergone Surgery for Prostate Cancer (NCT00541047) in 2019, that early salvage radiation therapy is preferred over adjuvant radiation therapy in all scenarios during a pandemic.…”

Section: Recommendationsmentioning

confidence: 99%

Prostate Cancer Radiation Therapy Recommendations in Response to COVID-19

Zaorsky¹,

Yu²,

McBride³

et al. 2020

Advances in Radiation Oncology

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Purpose During a global pandemic, the benefit of routine visits and treatment of patients with cancer must be weighed against the risks to patients, staff, and society. Prostate cancer is one of the most common cancers radiation oncology departments treat, and efficient resource utilization is essential in the setting of a pandemic. Herein, we aim to establish recommendations and a framework by which to evaluate prostate radiation therapy management decisions. Methods and Materials Radiation oncologists from the United States and the United Kingdom rapidly conducted a systematic review and agreed upon recommendations to safely manage patients with prostate cancer during the COVID-19 pandemic. A RADS framework was created: remote visits, and avoidance, deferment, and shortening of radiation therapy was applied to determine appropriate approaches. Results Recommendations were provided by the National Comprehensive Cancer Network risk group regarding clinical node-positive, postprostatectomy, oligometastatic, and low-volume M1 disease. Across all prostate cancer stages, telemedicine consultations and return visits were recommended when resources/staff available. Delays in consultations and return visits of between 1 and 6 months were deemed safe based on stage of disease. Treatment can be avoided or delayed until safe for very low, low, and favorable intermediate-risk disease. Unfavorable intermediate-risk, high-risk, clinical node-positive, recurrence postsurgery, oligometastatic, and low-volume M1 disease can receive neoadjuvant hormone therapy for 4 to 6 months as necessary. Ultrahypofractionation is preferred for localized, oligometastatic, and low-volume M1, and moderate hypofractionation is preferred for postprostatectomy and clinical node positive disease. Salvage is preferred to adjuvant radiation. Conclusions Resources can be reduced for all identified stages of prostate cancer. The RADS (remote visits, and avoidance, deferment, and shortening of radiation therapy) framework can be applied to other disease sites to help with decision making in a global pandemic.

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A Phase III Multi-Centre Randomised Trial comparing adjuvant versus early salvage Radiotherapy following a Radical Prostatectomy: Results of the TROG 08.03 and ANZUP “RAVES” Trial

Cited by 40 publications

References 0 publications

External Validation of an MRI-Derived Radiomics Model to Predict Biochemical Recurrence after Surgery for High-Risk Prostate Cancer

External Validation of an MRI-Derived Radiomics Model to Predict Biochemical Recurrence after Surgery for High-Risk Prostate Cancer

Combined Long-Term Androgen Deprivation and Pelvic Radiotherapy in the Post-operative Management of Pathologically Defined High-Risk Prostate Cancer Patients: Results of the Prospective Phase II McGill 0913 Study

Prostate Cancer Radiation Therapy Recommendations in Response to COVID-19

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