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Urinary toxicity is common following pelvic radiotherapy and can have a substantial negative effect on survivorship. Due to its prevalence and the increasing number of related clinical trials, localised prostate cancer radiotherapy is a useful illustrative tool to explore urinary toxicity. A good understanding of the interplay between anatomy, radiation-sensitive cell populations, and treatment sequencing is necessary for optimal outcomes. Emerging evidence suggests that the prostatic urethra is a radiation-sensitive structure, not only for stricture development, but also chronic irritative symptoms. Tools now exist not only to identify the urethra, but also to direct radiation dose away from the urethra, with early data suggesting that this reduces moderate-to-severe late urinary toxicity. Coupled with new evidence supporting dominant nodule microboosting and ultrahypofractionation as emerging standards of care, urethral sparing radiotherapy is a powerful tool against radiation induced urinary toxicity while also maximising disease control.

To perform implanted fiducial based real-time target position monitoring in pancreas stereotactic body radiotherapy (SBRT) using the x-ray imaging system available in a Elekta linear accelerator. An in-house system was developed and clinically utilised for real-time target position monitoring of pancreas SBRT delivery. The developed system was used for the target position monitoring of a pancreas cancer patient treated in free breathing treatment within the study entitled 'Mfolfirinox And STEreotactic Radiotherapy for Patients with Locally Advanced paNcreas cancer (MASTERPLAN): a feasibility study' (ACTRN 12617001642370) consisting of five treatment fractions. The clinical efficacy of the system was studied by performing a retrospective cumulative dose assessment of delivered dose using observed position deviations. The developed system identified two events of baseline shifts in target position that exceeded the accepted tolerance level of ± 3 mm from reference planned position. The retrospective dose assessment study showed that if the position deviations were not detected and corrected for, the maximum dose to duodenum would have increased from 34.6 to 38.8 Gy. The first real-time position monitoring in pancreas SBRT on an Elekta linear accelerator was successfully performed. The developed system was shown to improve the safety and accuracy of SBRT delivery.

Purpose: Gantry-free radiation therapy systems utilizing patient rotation would be simpler and more cost effective than the conventional gantry-based systems. Such a system could enable the expansion of radiation therapy to meet global demand and reduce capital costs. Recent advances in adaptive radiation therapy could potentially be applied to correct for gravitational deformation during horizontal patient rotation. This study aims to quantify the pelvic organ motion and the dosimetric implications of horizontal rotation for prostate intensity-modulated radiation therapy (IMRT) treatments. Methods: Eight human participants who previously received prostate radiation therapy were imaged in a clinical magnetic resonance imaging (MRI) scanner using a bespoke patient rotation system (PRS). The patients were imaged every 45 degrees during a full roll rotation (0-360 degrees). Whole pelvic bone, prostate, rectum, and bladder motion were compared to the supine position using dice similarity coefficient (DSC) and mean absolute surface distance (MASD). Prostate centroid motion was compared in the left-right (LR), superior-inferior (SI), and anterior-posterior (AP) direction prior to and following pelvic bone-guided rigid registration. Seven-field prostate IMRT treatment plans were generated for each patient rotation angles under three adaption scenarios: No plan adaption, rigid planning target volume (PTV)-guided alignment to the prostate, and plan re-optimization. Prostate, rectum, and bladder doses were compared for each adaption scenario. Results: Pelvic bone motion within the PRS of up to 53 mm relative to the supine position was observed for some participants. Internal organ motion was greatest at the 180-degree PRS couch angle (prone), with prostate centroid motion range < 2 mm LR, 0 mm to 14 mm SI, and -11 mm to 4 mm AP. Rotation with no adaption of the treatment plan resulted in an underdose to the PTV -- in some instances up to 75% (D95%: 78 ± 0.3 Gy at supine to 20 ± 15.0 Gy at the 225-degree PRS couch angle). Bladder dose was reduced during the rotation by up to 98% (V60 Gy: 15.0 ± 9.4% supine to 0.3 ± 0.5% at the 225-degree PRS couch angle). In some instances, the rectum dose increased during rotation (V60Gy: 20.0 ± 4.5% supine to 25.0 ± 15.0% at the 135-degree PRS couch angle). Rigid PTV-guided alignment resulted in PTV coverage which, though statistically lower (P < 0.05 for all D95% values), was within 1 Gy of the supine plans. Plan re-optimization resulted in a statistically equivalent PTV coverage compared to the supine plans (P > 0.05 for all D95% metrics and all within ±0.4 Gy). For both rigid PTV-guided alignment and plan re-optimization, rectum dose volume metrics were reduced compared to the supine position between the 90- and 225-degree PRS couch angles (P < 0.05). Bladder dose volume metrics were not impacted by rotation. Conclusion: Pelvic bone and internal organ motion are present during patient rotation. Rigid PTV-guided alignment to the prostate will be a requirement if prostate IMRT is to be safely delivered using patient rotation. Plan re-optimization for each PRS couch angle to account for anatomical deformations further improves the PTV coverage.

Summary Background Adjuvant radiotherapy has been shown to halve the risk of biochemical progression for patients with high-risk disease after radical prostatectomy. Early salvage radiotherapy could result in similar biochemical control with lower treatment toxicity. We aimed to compare biochemical progression between patients given adjuvant radiotherapy and those given salvage radiotherapy. Methods We did a phase 3, randomised, controlled, non-inferiority trial across 32 oncology centres in Australia and New Zealand. Eligible patients were aged at least 18 years and had undergone a radical prostatectomy for adenocarcinoma of the prostate with pathological staging showing high-risk features defined as positive surgical margins, extraprostatic extension, or seminal vesicle invasion; had an Eastern Cooperative Oncology Group performance status of 0–1, and had a postoperative prostate-specific antigen (PSA) concentration of 0·10 ng/mL or less. Patients were randomly assigned (1:1) using a minimisation technique via an internet-based, independently generated allocation to either adjuvant radiotherapy within 6 months of radical prostatectomy or early salvage radiotherapy triggered by a PSA of 0·20 ng/mL or more. Allocation sequence was concealed from investigators and patients, but treatment assignment for individual randomisations was not masked. Patients were stratified by radiotherapy centre, preoperative PSA, Gleason score, surgical margin status, and seminal vesicle invasion status. Radiotherapy in both groups was 64 Gy in 32 fractions to the prostate bed without androgen deprivation therapy with real-time review of plan quality on all cases before treatment. The primary endpoint was freedom from biochemical progression. Salvage radiotherapy would be deemed non-inferior to adjuvant radiotherapy if freedom from biochemical progression at 5 years was within 10% of that for adjuvant radiotherapy with a hazard ratio (HR) for salvage radiotherapy versus adjuvant radiotherapy of 1·48. The primary analysis was done on an intention-to-treat basis. This study is registered with ClinicalTrials.gov , NCT00860652 . Findings Between March 27, 2009, and Dec 31, 2015, 333 patients were randomly assigned (166 to adjuvant radiotherapy; 167 to salvage radiotherapy). Median follow-up was 6·1 years (IQR 4·3–7·5). An independent data monitoring committee recommended premature closure of enrolment because of unexpectedly low event rates. 84 (50%) patients in the salvage radiotherapy group had radiotherapy triggered by a PSA of 0·20 ng/mL or more. 5-year freedom from biochemical progression was 86% (95% CI 81–92) in the adjuvant radiotherapy group versus 87% (82–93) in the salvage radiotherapy group (stratified HR 1·12, 95% CI 0·65–1·90; pnon-inferiority=0·15). The grade 2 or worse genitourinary toxicity rate was lower in the salvage radiotherapy group (90 [54%] of 167) than in the adjuvant radiotherapy group (116 [70%] of 166). The grade 2 or worse gastrointestinal toxicity rate was similar between the salvage radiotherapy group (16 [10%]) and the adjuvant radiotherapy group (24 [14%]). Interpretation Salvage radiotherapy did not meet trial specified criteria for non-inferiority. However, these data support the use of salvage radiotherapy as it results in similar biochemical control to adjuvant radiotherapy, spares around half of men from pelvic radiation, and is associated with significantly lower genitourinary toxicity. Funding New Zealand Health Research Council, Australian National Health Medical Research Council, Cancer Council Victoria, Cancer Council NSW, Auckland Hospital Charitable Trust, Trans-Tasman Radiation Oncology Group Seed Funding, Cancer Research Trust New Zealand, Royal Australian and New Zealand College of Radiologists, Cancer Institute NSW, Prostate Cancer Foundation Australia, and Cancer Australia.

To evaluate the feasibility of prostate intrafraction motion monitoring using the SeedTracker real-time image guidance system in order to improve targeting accuracy in prostate radiotherapy.SeedTracker was used to monitor prostate gold fiducial seeds with kV x-ray imaging during radiotherapy in 30 patients. Feedback from radiation therapists was collected via the use of a user evaluation form. The impact on treatment time was established by using a record and verify system. The effective dose and a risk of exposure-induced cancer death (REID) were estimated for a 60-year-old patient when using the SeedTracker system.A total of 22 radiation therapists completed user evaluation forms. The time taken to prepare a reference data set for one patient varied with three (13.6%) radiation therapists taking less than 2 min, 10 (45.5%) between 2 and 4 min, eight (36.4%) between 4 and 6 min and one (4.5%) between 6 and 8 min. The useability of the SeedTracker system was reported as 'easy' by 21 (95.5%) radiation therapists and 'hard' by 1 (4.5%) radiation therapist. Mean treatment time changed from 6 to 7 min with prostate-only radiotherapy treatment and from 6.9 to 10.2 min with prostate and whole pelvis radiotherapy treatments. The maximum effective dose with the SeedTracker was 1.6276 mSv, and increase in REID was 0.007%.The SeedTracker real-time image guidance system is a feasible tool to use in radiotherapy departments to monitor and correct for prostate intrafraction motion.

Prostate cancer (PC) is the most common malignancy in men. Internal radiotherapy (brachytherapy) has been used to treat PC successfully for over a century. In particular, there is level-one evidence of the benefits of using brachytherapy to escalate the dose of radiotherapy compared with standard external beam radiotherapy approaches. However, the use of PC brachytherapy is declining, despite strong evidence for its improved cancer outcomes. A method using external beam radiotherapy known as virtual high-dose-rate brachytherapy boost (vHDRB) aims to noninvasively mimic a brachytherapy boost radiation dose plan. In this review, we consider the evidence supporting brachytherapy boosts for PC and the continuing evolution of vHDRB approaches, culminating in the current generation of clinical trials, which will help define the role of this emerging modality.

Objective To understand how best to support men diagnosed with localised prostate cancer to decide which treatment option best suits their needs, when robotic prostatectomy and radiotherapy are equally appropriate to offer them. Methods Twenty-five men recently diagnosed with localised prostate cancer completed semi-structured interviews asking about information/decision-making needs before and/or after attending a combined clinic in which they consulted a urologist and a radiation oncologist regarding treatment options. Data was transcribed verbatim and thematically analysed. Results Most men preferred robotic prostatectomy pre-combined clinic and chose it afterwards. The thematic analysis revealed four themes: 1) trust in clinicians and the information they provide is critical for treatment choice, 2) perceived fit between treatment characteristics and personal circumstances, 3) additional considerations: specific side effects, socio-emotional and financial factors, and 4) need for tailored information delivery. Robotic prostatectomy was mistakenly believed to provide a more definitive cure than radiotherapy, which was seen as having a lesser lifestyle impact. Conclusions Treatment choice is largely dependent on clinicians’ (mainly urologists’) recommendations. Practice implications Patients need more balanced information about alternatives to robotic prostatectomy earlier in the treatment decision-making process. Referral to a radiation oncologist or combined clinic shortly after diagnosis is recommended.

Introduction Variation in target volume delineation from clinical trial protocols has been shown to contribute to poorer patient outcomes. A clinical trial quality assurance framework can support compliance with trial protocol. Results of the TROG 08.03 RAVES benchmarking exercise considering variation from protocol, inter-observer variability and impact on dosimetry are reported in this paper. Methods Clinicians were required to contour and plan a benchmarking case according to trial protocol. Geometric pjmirometers including volume, Hausdorff Distance, Mean Distance to Agreement and DICE similarity coefficient were analysed for targets and organs at risk. Submitted volumes were compared to a STAPLE and consensus 'reference' volume for each structure. Dosimetric analysis was performed using dose volume histogram data. Results Benchmarking exercise submissions were received from 96 clinicians. In total 205 protocol variations were identified. The most common variation was inadequate contouring of the CTV in 84/205 (41%). The CTV volume ranged from 65.3 to 193.1 cm3 with a median of 113.2 cm3 . The most common dosimetric protocol variation related to rectal dosimetry. The mean submitted rectal volume receiving 40 Gy and 60 Gy, respectively, was 56.14% ± 5.55% and 30.25% ± 6.15%. When corrected to the protocol defined length the mean rectal volume receiving 40 Gy was 60.8% ± 7.92%, while the volume receiving 60 Gy was 33.86% ± 8.21%. Conclusion Variations from protocol were found in the RAVES benchmarking exercise, most notably in CTV and rectum delineation. Inter-observer variability was evident. Incorrect delineation of the rectum impacted on dosimetric compliance with protocol.

Volume delineation quality assurance (QA) is particularly important in clinical trial settings where consistent protocol implementation is required, as outcomes will affect future as well current patients. Currently, where feasible, this is conducted manually, which is time consuming and resource intensive. Although previous studies mostly focused on automating delineation QA on CT, magnetic resonance imaging (MRI) is being increasingly used in radiotherapy treatment. In this work, we propose to perform automatic delineation QA on prostate MRI for both the clinical target volume (CTV) and organs-at-risk (OARs) by using delineations generated by 3D Unet variants as benchmarks for QA. These networks were trained on a small gold standard atlas set and applied on a multicentre radiotherapy clinical trial dataset to generate benchmark delineations. Then, a QA stage was designed to recommend 'pass', 'minor correction' and 'major correction' for each manual delineation in the trial set by thresholding its Dice similarity coefficient to the network generated delineation. Among all 3D Unet variants explored, the Unet with anatomical gates in an AtlasNet architecture performed the best in delineation QA, achieving an area under the receiver operating characteristics curve of 0.97, 0.92, 0.89 and 0.97 for identifying unacceptable (major correction) delineations with a sensitivity of 0.93, 0.73, 0.74 and 0.90 at a specificity of 0.93, 0.86, 0.86 and 0.95 for bladder, prostate CTV, rectum and gel spacer respectively. To the best of our knowledge, this is the first study to propose automated delineation QA for a multicentre radiotherapy clinical trial with treatment planning MRI. The methods proposed in this work can potentially improve the accuracy and consistency of CTV and OAR delineation in radiotherapy treatment planning.

Decisional conflict and post-treatment decisional regret have been documented in men with localised prostate cancer (LPC). However, there is limited evidence regarding decisional outcomes associated with the choice between robotic-assisted radical prostatectomy (RARP) and radiotherapy, when both treatment options are available in the public health system. There is increasing support for multidisciplinary approaches to guide men with LPC in their decision-making process. This study assessed decisional outcomes in men deciding between RARP or radiotherapy treatment before and after attending a LPC combined clinic (CC).Quantitative longitudinal data were collected from 52 men who attended a LPC CC, where they saw both a urologist and radiation oncologist. Patients completed questionnaires assessing involvement in decision-making, decisional conflict, satisfaction and regret before and after the CC, three months, six months and 12 months post-treatment. Urologists and radiation oncologists also reported their perceptions regarding patients' suitability for, openness to, perceived preferences and appropriateness for each treatment. Data was analysed using paired/independent samples t-tests and McNemar's tests.Most participants (n = 37, 71%) opted for RARP over radiotherapy (n = 14, 27%); one participant deferred treatment (2%). Urologists and radiation oncologists reported low agreement (κ = 0.26) regarding the most appropriate treatment for each patient. Participants reported a desire for high levels of control over their decision-making process (77.5% patient-led, 22.5% shared) and high levels of decisional satisfaction (M = 4.4, SD = 0.47) after the CC. Decisional conflict levels were significantly reduced (baseline: M = 29.3, SD = 16.9, post-CC: M = 16.3, SD = 11.5; t = 5.37, P0.001) after the CC. Mean decisional regret scores were 'mild' at three-months (M = 16.0, SD = 17.5), six-months (M = 18.8, SD = 18.7) and 12-months (M = 18.2, SD = 15.1) post-treatment completion.This is the first Australian study to assess decisional outcomes when patients are offered the choice between RARP and radiotherapy in the public health system. A CC seems to support decision-making in men with LPC and positively impact some decisional outcomes. However, larger-scale controlled studies are needed to confirm these findings.

Introduction: Recent advances in image guidance and adaptive radiotherapy could enable gantry-free radiotherapy using patient rotation. Gantry-free radiotherapy could substantially reduce the cost of radiotherapy systems and facilities. MRI guidance complements a gantry-free approach because of its ability to visualise soft tissue deformation during rotation. A potential barrier to gantry-free radiotherapy is patient acceptability, especially when combined with MRI. This study investigates human experiences of horizontal rotation within an MRI scanner. Methods: Ten healthy human participants and nine participants previously treated with radiotherapy were rotated within an MRI scanner. Participants' anxiety and motion sickness was assessed before being rotated in 45-degree increments and paused, representing a multi-field intensity-modulated radiotherapy treatment. An MR image was acquired at each 45-degree angle. Following imaging, anxiety and motion sickness were re-assessed, followed by a comfort questionnaire and exit interview. The significance of the differences in anxiety and motion sickness pre- versus post-imaging was assessed using Wilcoxon signed-rank tests. Content analysis was performed on exit interview transcripts. Results: Eight of ten healthy and eight of nine patient participants completed the imaging session. Mean anxiety scores before and after imaging were 7.9/100 and 11.8/100, respectively (P = 0.26), and mean motion sickness scores were 5.3/100 and 13.7/100, respectively (P = 0.02). Most participants indicated likely acceptance of rotation if MRI were to be used in a hypothetical treatment. Physical discomfort was reported to be the biggest concern. Conclusions: Horizontal rotation within an MRI scanner was acceptable for most (17/19) participants.

Introduction Optimal definitive treatment of prostate cancer is controversial, especially in high-risk patients. We report the largest prospective cohort of Australian patients treated with radiotherapy for localised prostate cancer. Methods One thousand, one hundred and twenty-one patients with prostate cancer were prospectively registered and treated to a dose of 70-74 Gy. Patients were classified as low, intermediate or high risk based on PSA, clinical staging and Gleason score. Intermediate-risk patients were treated with 0-6 months of hormonal therapy (ADT) and high-risk patients were offered neoadjuvant and adjuvant ADT. Overall survival (OS) and biochemical relapse-free survival (bNED) were calculated using the Kaplan-Meier method. Results Median follow-up was 92 months. Eight-year OS and bNED were 78.4% and 68.1% respectively in the entire cohort. OS for the low, intermediate and high-risk groups was 84.5%, 78.4% and 68% respectively. For these risk groups, bNED was 80.3%, 65.7% and 53.7% respectively. In the intermediate and high-risk group, OS and bNED decreased with increasing number of risk factors. Conclusion Definitive radiotherapy is an effective treatment for prostate cancer, including in high-risk cases.

Purpose To develop and validate a variable angle stereo image based position correction methodology in an X-ray based in-house online position monitoring system. Materials and methods A stereo imaging module that enables 3D position determination and couch correction of the patient based on images acquired at any arbitrary angle and arbitrary angular separation was developed and incorporated to the in-house SeedTracker real-time position monitoring system. The accuracy of the developed system was studied by imaging an anthropomorphic phantom implanted with radiopaque markers set to known offset positions from its reference position in an Elekta linear accelerator (LA) and associated XVI imaging system. The accuracy of the system was further validated using CBCT data set from 10 prostate SBRT patients. The time gains achieved with the stereo image based position correction was compared with the manual matching of seed positions in Digitally Reconstructed Radiographs (DRRs) and kV images in the Mosaiq record and verify system. Results Based on phantom and patient CBCT dataset study stereo imaging module implemented in the SeedTracker shown to have an accuracy of 0.1(σ = 0.5) mm in detecting the 3D position offset. The time comparison study showed that stereo image based methodology implemented in SeedTracker was a minimum of 80(4) s faster than the manual method implemented in Mosaiq R&V system with a maximum time saving of 146(6) s. Conclusion The variable angle stereo image based position correction method was shown to be accurate and faster than the standard manual DRR–kV image based correction approach, leading to more efficient treatment.

PurposeKilovoltage intrafraction monitoring (KIM) is a novel software platform implemented on standard radiation therapy systems and enabling real-time image guided radiation therapy (IGRT). In a multi-institutional prospective trial, we investigated whether real-time IGRT improved the accuracy of the dose patients with prostate cancer received during radiation therapy.Methods and materialsForty-eight patients with prostate cancer were treated with KIM-guided SABR with 36.25 Gy in 5 fractions. During KIM-guided treatment, the prostate motion was corrected for by either beam gating with couch shifts or multileaf collimator tracking. A dose reconstruction method was used to evaluate the dose delivered to the target and organs at risk with and without real-time IGRT. Primary outcome was the effect of real-time IGRT on dose distributions. Secondary outcomes included patient-reported outcomes and toxicity.ResultsMotion correction occurred in ≥1 treatment for 88% of patients (42 of 48) and 51% of treatments (121 of 235). With real-time IGRT, no treatments had prostate clinical target volume (CTV) D98% dose 5% less than planned. Without real-time IGRT, 13 treatments (5.5%) had prostate CTV D98% doses 5% less than planned. The prostate CTV D98% dose with real-time IGRT was closer to the plan by an average of 1.0% (range, -2.8% to 20.3%). Patient outcomes showed no change in the 12-month patient-reported outcomes compared with baseline and no grade ≥3 genitourinary or gastrointestinal toxicities.ConclusionsReal-time IGRT is clinically effective for prostate cancer SABR.

INTRODUCTION AND OBJECTIVES:To understand the decision making process in men diagnosed with localised prostate cancer (LPC) who are attending a combined clinic (CC), deciding between robotic prosta...

The management of node-positive prostate cancer is highly variable, with both locoregional and systemic treatment options available. With the increasing use of novel imaging techniques such as PSMA-PET and MRI, combined with the increasing use of surgery for high-risk prostate cancer, clinical and pathological regional nodal disease is being detected at a higher rate and at an earlier stage than previously. This creates a window for a potentially curative management approach. The role of radiotherapy including optimal radiation target volumes and dose, as well as the timing and duration of accompanying systemic therapy remains uncertain. At a workshop in 2017, the Australian and New Zealand Faculty of Radiation Oncology Genito-Urinary Group (FROGG) identified variations in the management of node-positive prostate cancer identified on primary staging or on histopathology at radical prostatectomy. FROGG reviewed the literature and developed a set of evidence-based recommendations on the appropriate investigation and management of clinically and pathologically node-positive prostate cancer. These recommendations encompass imaging techniques, radiation treatment target volumes and doses, as well as the use of androgen deprivation therapy.

Purpose: A subset of patients treated with postprostatectomy radiation therapy for biochemical recurrence after surgery fail to respond because of microscopic disease beyond the irradiated prostate bed. This work aims to determine whether a rising interim prostate-specific antigen (PSA) during radiation therapy can predict the likelihood of subsequent biochemical recurrence. Methods and Materials: Between 2010 and 2016, 185 patients had salvage radiation therapy to a dose of 68 Gy without androgen deprivation therapy for a rising PSA level after radical prostatectomy. Patients had their PSA recorded on the first day of radiation therapy and again after completing the 25th fraction (of 34 total fractions). Biochemical failure after radiation therapy was defined as a PSA value ≥0.2 ng/mL within 2 years after radiation therapy. Both univariate and multivariate Cox regression models were used for statistical analysis. Factors with a P value of

Purpose: Accurate positioning of the target volume during treatment is paramount for stereotactic body radiation therapy (SBRT). In this work, the authors present the development of an in-house software tool to verify target position with an Elekta-Synergy linear accelerator using kV planar images acquired during treatment delivery. Methods: In-house software, SeedTracker, was developed in matlab to perform the following three functions: 1. predict intended seed positions in a planar view perpendicular to any gantry angle, simulating a portal imaging device, from the 3D seed co-ordinates derived from the treatment planning system; 2. autosegment seed positions in kV planar images; and 3. report the position shift based on the seed positions in the projection images. The performance of SeedTracker was verified using a CIRS humanoid phantom (CIRS, VA, USA) implanted with three Civco gold seed markers (Civco, IA, USA) in the prostate. The true positive rate of autosegmentation (TPRseg) and the accuracy of the software in alerting the user when the isocenter position was outside the tolerance (TPRtrig) were studied. Two-dimensional and 3D static position offsets introduced to the humanoid phantom and 3D dynamic offsets introduced to a gel phantom containing gold seeds were used for evaluation of the system. Results: SeedTracker showed a TPRseg of 100% in the humanoid phantom for projection images acquired at all angles except in the ranges of 80°–100° and 260°–280° where seeds are obscured by anatomy. This resulted in a TPRtrig of 88% over the entire treatment range for considered 3D static offsets introduced to the phantom. For 2D static offsets where the position offsets were only introduced in the anterior–posterior and lateral directions, the TPRtrig of SeedTracker was limited by both seed detectability and positional offset. SeedTracker showed a false positive trigger in the projection angle range between 130°–170° and 310°–350° (a maximum of 24% of treatment time) due to limited information that can be derived from monoscopic images. The system accurately determined the dynamic trajectory of the isocenter position in the superior and inferior direction for the studied dynamic offset scenarios based on the seed position in monoscopic images. Conclusions: The developed software has been shown to accurately autosegment the seed positions in kV planar images except for two 20° arcs where seeds are obscured by anatomical structures. The isocenter trajectories determined by the system, based on the monoscopic images, provide useful information for monitoring the prostate position. The developed system has potential application for monitoring prostate position during treatment delivery in linear accelerator based SBRT.

Stereotactic ablative body radiotherapy (SABR) is demonstrating good local control for patients with inoperable primary renal cell carcinoma. In a previous pilot study we identified magnetic resonance imaging (MRI) early response biomarkers that correlate with later morphological changes in computed tomography (CT) images. These early functional changes in diffusion and perfusion following radiotherapy were observed on MRI and have the potential to identify non-responders who may benefit from adjuvant or salvage therapies. Here we detail the imaging protocol for an MRI sub-study of the Focal Ablative STereotactic Radiosurgery for Cancers of the Kidney (FASTRACK II) trial. A preliminary patient case demonstrates the high quality of the imaging data, with discussion of the improvements made from the pilot protocol for improved motion management and correction. We aim to validate the previously identified early response MRI biomarkers with this rich prospective multi-centre dataset.

365 Background: External beam radiation therapy (EBRT) with androgen suppression (AS) and low dose rate (LDR)brachytherapy boost has been shown to improve biochemical progression free survival in unfavorable intermediate risk and high-risk prostate cancer (PC) compared to EBRT and AS. Excellent rates of local control in locally advanced prostate cancer with EBRT with high dose rate brachytherapy (HDR) boost. Prostate Stereotactic Radiosurgery (SBRT) may be an alternative to brachytherapy in patients with unfavorable intermediate and high-risk PC. Here we report the toxicity of pelvic lymph node/prostate EBRT and SBRT as the radiation boost in a large retrospective cohort. Methods: 473 patients with intermediate or high-risk PC, from the Radiosurgery Society Registry, Beth Israel Deaconess Medical Center, Georgetown University, and 5 Australian centers, were included. Patients received treatment from 3/2004- 9/2018 were the basis of this IRB approved retrospective study. The prostate and pelvis nodes were treated with between 36-50.4 Gy in 1.8/2.0 Gy fractions of radiation therapy EBRT. Patients received a SBRT boost to the prostate. Boost dose was 19-19.5 Gy (range 19-36.25 Gy). 274 and 199 patients presented with unfavorable or high-risk disease. The median follow-up was 33 months (IQR:18-63). Results: 33 deaths of 473 patients occurred in this cohort, 8 of which were caused by PC. There were 13.9% (n=66) acute Grade 1 or 2 GI toxicities (11.8% grade 1, 2.1% grade 2). There were 27.7% (n=131) acute Grade 1 or 2 GU toxicities (19.2% grade 1, 8.5% grade 2). No severe acute GU or GI toxicities were reported. There were 32 (6.8%) Grade 1 and 3 (0.6%) Grade 2 late GI toxicities. There were 9 (1.9%) Grade 3 and 1 (0.2%) Grade 4 late GI toxicities. There were 60 (12.7%) Grade 1 and 23 (4.9%) Grade 2 late GU toxicities. 15 (3.2%) Grade 3, but no Grade 4 late GU toxicity were reported. Conclusions: In this large multi-institutional retrospective cohort SBRT boost to pelvic/prostate EBRT had acceptable acute and late toxicities. The high dose per fraction of SBRT is similar to the dose delivered with HDR. This data raises the hypothesis that SBRT boost should be evaluated in additional clinical trials.

The management of patients with biochemical, local, nodal, or oligometastatic relapsed prostate cancer has become more challenging and controversial. Novel imaging modalities designed to detect recurrence are increasingly used, particularly PSMA-PET scans in Australia, New Zealand and some European countries. Imaging techniques such as MRI and PET scans using other prostate cancer-specific tracers are also being utilised across the world. The optimal timing for commencing salvage treatment, and the role of local and/or systemic therapies remains controversial. Through surveys of the membership, the Australian and New Zealand Faculty of Radiation Oncology Genito-Urinary Group (FROGG) identified wide variation in the management of recurrent prostate cancer. Following a workshop conducted in April 2017, the FROGG management committee reviewed the literature and developed a set of recommendations based on available evidence and expert opinion, for the appropriate investigation and management of recurrent prostate cancer. These recommendations cover the role and timing of post-prostatectomy radiotherapy, the management of regional nodal metastases and oligometastases, as well as the management of local prostate recurrence after definitive radiotherapy.

Purpose To explore site- and clinician-level factors associated with protocol violations requiring real-time-review (RTR) resubmission in a multicenter clinical trial to help tailor future quality assurance (QA) protocols. Methods and Materials RAVES (Radiation Therapy–Adjuvant vs Early Salvage) (Trans-Tasman Radiation Oncology Group 08.03) is a randomized trial comparing adjuvant with early salvage radiation therapy in men with positive surgical margins or pT3 disease after prostatectomy. Quality assurance in RAVES required each clinician and site to submit a credentialing dummy run (DR) and for each patient's radiation therapy plan to undergo external RTR before treatment. Prospectively defined major violations from trial protocol required remedy and resubmission. Site and clinician factors associated with RTR resubmission were examined using hierarchical modeling. Results Data were collected from 171 consecutive patients, treated by 46 clinicians at 32 hospitals. There were 47 RTR resubmissions (27%) due to 65 major violations. The relative rate of resubmission decreased by 29% per year as the study progressed (odds ratio OR. 0.71, P =.02). The majority of resubmissions were due to contouring violations (39 of 65) and dosimetric violations (22 of 65). For each additional patient accrued, significant decreases in RTR resubmission were seen at both clinician level (OR 0.75, P =.02) and site level (OR 0.72, P =.01). The rate of resubmission due to dosimetric violations was only 1.6% after the first 5 patients. Use of IMRT was associated with lower rates of resubmission compared with 3-dimensional conformal radiation therapy (OR 0.38, P =.05). Conclusion Several low- and high-risk factors that may assist with tailoring future clinical trial QA were identified. Because the real-time resubmission rate was largely independent of the credentialing exercise, some form of RTR QA is recommended. The greatest benefit from QA was derived early in trial activation and clinician experience.

INTRODUCTION: We tested the ability of the Assessment of New Radiation Oncology Technology and Treatments framework to determine the clinical efficacy and safety of intensity-modulated radiation therapy (IMRT) compared with 3-dimensional radiation therapy (3DCRT) for post-prostatectomy radiation therapy (PPRT) to support its timely health economic evaluation. METHODS: Treatment plans produced using FROGG guidelines provided dosimetry parameters for both techniques at 64 Gy and 70 Gy and were also used to model early and late outcome probabilities. Clinical parameters were derived from early toxicity and quality of life patient data, systematic literature review and expert opinion. Dosimetry parameters were correlated with the measures of clinical efficacy and safety. RESULTS: Data from two patient cohorts (29 and 27 respectively) were collected within the project timeframe, providing evidence for acute toxicity and quality of life, and dosimetric comparisons. Relative rates of tumour control probability (TCP) and normal tissue control probability (NTCP) modelling were readily derived from the planning exercise and demonstrated advantages in uncomplicated TCP for IMRT over 3DCRT, predominantly due to normal tissue sparing. The safety of IMRT delivery was demonstrated with TCP uncompromised by IMRT protocol violations, which achieved rectal sparing only by reducing minimum target dose and coverage. Conclusion: Sources of desk-top and patient-based evidence were successfully used to demonstrate potential improved clinical efficacy and safety of applying dose escalation using IMRT instead of 3DCRT in PPRT.

Introduction We investigated the endorectal balloon (ERB) as a method to improve post-prostatectomy clinical target volume (CTV) stability. Methods Seventy cone-beam CT (CBCT) obtained during radiotherapy treatment from seven patients treated with an ERB and 68 CBCT from seven patients treated without an ERB were contoured according to published guidelines. CTV was subdivided into superior and inferior CTV; whole rectal volume was subdivided into superior and inferior rectum and anal volume. Concordance index (CI) of CBCT treatment volumes compared with planning volumes was calculated and displacements were measured. Results Whole rectal, superior and inferior rectum and anal CI were significantly improved with the ERB by 21%, 17%, 26% and 17% respectively (P

Stereotactic ablative body radiotherapy is used in prostate cancer to deliver a high dose of radiation to the tumour over a small number of treatments. This involves the simulation of the patient using both CT and MRI. Current practice is to insert an indwelling catheter (IDC) during CT to assist with visualisation of the urethra and subsequently minimise dose to this highly critical structure. However, this procedure is invasive and has an associated risk of infection. This is a case study, which demonstrates our initial experience of using a real-time non-invasive MRI technique to replace the use of IDC for prostate cancer patients. The patient was scanned on a dedicated 3T MRI and was instructed to micturate in their own time whereupon a sagittal T2 weighted HASTE sequence was acquired every 5 s. This was subsequently followed by T2 weighted axial imaging at the level of mid prostate to provide improved urethral definition. Acquired images showed bladder voidance in real-time and an increase in signal intensity in the proximal urethra post voiding allowing for delineation of the urethra. The dimension and shape of the proximal urethra was well visualised and accumulation time of urine in the urethra was sufficient to enable optimum timing of the scanning technique. We have presented for the first time a micturating urethography technique using MRI, which has allowed us to visualise the urethra without contrast and with minimal invasiveness to the patient.

Introduction High rectal doses are associated with increased toxicity. A rectal displacement device (RDD) reduces rectal dose in prostate stereotactic body radiation therapy (SBRT). This study investigates any dosimetric difference between two methods of rectal displacement (Rectafix and SpaceOAR) for prostate SBRT. Methods Rectal dosimetry of 45 men who received SBRT within the PROMETHEUS trial was retrospectively examined, across two radiation therapy centres using the two RDD's. Men received a total dose (TD) of 19 or 20 Gy in two fractions followed by 46 Gy in 23 fractions. Centre 1 contributed 16 Rectafix and 10 SpaceOAR patients. Centre 2 contributed 19 Rectafix patients. Rectal dose volume histogram (DVH) data were recorded as a TD percentage at the following volume intervals; V1%, V2%, V5%, V10% and then 10% increments to V80%. As only one centre employed both RDD's, three sequential rectal dosimetry comparisons were performed; (1) centre 1 Rectafix versus centre 1 SpaceOAR; (2) centre 1 Rectafix versus centre 2 Rectafix and (3) centre 1+ centre 2 Rectafix versus centre 1 SpaceOAR. Results In comparison (1) Rectafix demonstrated lower mean doses at 9 out of 11 measured intervals (P = 0.0012). Comparison (2) demonstrated a moderate difference with centre 2 plans producing slightly lower rectal doses (P = 0.013). Comparison (3) further demonstrated that Rectafix returned lower mean doses than SpaceOAR (P < 0.001). Although all dose levels were in favour of Rectafix, in absolute terms differences were small (2.6–9.0%). Conclusions In well‐selected prostate SBRT patients, Rectafix and SpaceOAR RDD's provide approximately equivalent rectal sparing.

Objectives To test the hypothesis that observation with early salvage radiotherapy (SRT) is not inferior to ‘standard’ treatment with adjuvant RT (ART) with respect to biochemical failure in patients with pT3 disease and/or positive surgical margins (SMs) after radical prostatectomy (RP). To compare the following secondary endpoints between the two arms: patient-reported outcomes, adverse events, biochemical failure-free survival, overall survival, disease-specific survival, time to distant failure, time to local failure, cost utility analysis, quality adjusted life years and time to androgen deprivation. Patients and Methods The Radiotherapy – Adjuvant Versus Early Salvage (RAVES) trial is a phase III multicentre randomised controlled trial led by the Trans Tasman Radiation Oncology Group (TROG), in collaboration with the Urological Society of Australia and New Zealand (USANZ), and the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP). In all, 470 patients are planned to be randomised 1:1 to either ART commenced at ≤4 months of RP (standard of care) or close observation with early SRT triggered by a PSA level of >0.20 ng/mL (experimental arm). Eligible patients have had a RP for adenocarcinoma of the prostate with at least one of the following risk factors: positive SMs ± extraprostatic extension ± seminal vesicle involvement. The postoperative PSA level must be ≤0.10 ng/mL. Rigorous investigator credentialing and a quality assurance programme are designed to promote consistent RT delivery among patients. Results Trial is currently underway, with 258 patients randomised as of 31 October 2013. International collaborations have developed, including a planned meta-analysis to be undertaken with the UK Medical Research Council/National Cancer Institute of Canada Clinical Trials Group RADICALS (Radiotherapy and Androgen Deprivation In Combination with Local Surgery) trial and an innovative psycho-oncology sub-study to investigate a patient decision aid resource. Conclusion On the current evidence available, it remains unclear if ART is equivalent or superior to observation with early SRT.

IntroductionStereotactic body radiotherapy (SBRT) is a non-invasive alternative to surgery for the treatment of non-metastatic prostate cancer (PC). The objectives of the Novel Integration ofNew prostate radiation schedules with adJuvant Androgen deprivation (NINJA) clinical trial are to compare two emerging SBRT regimens for efficacy with technical substudies focussing on MRI only planning and the use of knowledge-based planning (KBP) to assess radiotherapy plan quality.Methods and analysisEligible patients must have biopsy-proven unfavourable intermediate or favourable high-risk PC, have an Eastern Collaborative Oncology Group (ECOG) performance status 0-1 and provide written informed consent. All patients will receive 6 months in total of androgen deprivation therapy. Patients will be randomised to one of two SBRT regimens. The first will be 40 Gy in five fractions given on alternating days (SBRT monotherapy). The second will be 20 Gy in two fractions given 1 week apart followed 2 weeks later by 36 Gy in 12 fractions given five times per week (virtual high-dose rate boost (HDRB)). The primary efficacy outcome will be biochemical clinical control at 5 years. Secondary endpoints for the initial portion of NINJA look at the transition of centres towards MRI only planning and the impact of KBP on real-time (RT) plan assessment. The first 150 men will demonstrate accrual feasibility as well as addressing the KBP and MRI planning aims, prior to proceeding with total accrual to 472 patients as a phase III randomised controlled trial.Ethics and disseminationNINJA is a multicentre cooperative clinical trial comparing two SBRT regimens for men with PC. It builds on promising results from several single-armed studies, and explores radiation dose escalation in the Virtual HDRB arm. The initial component includes novel technical elements, and will form an important platform set for a definitive phase III study.Trial registration numberANZCTN 12615000223538.