Prostate radiotherapy clinical trial quality assurance: How real should real time review be? (A TROG-OCOG Intergroup Project)

Purpose Men with localized prostate cancer often are treated with external radiotherapy (RT) over 8 to 9 weeks. Hypofractionated RT is given over a shorter time with larger doses per treatment than standard RT. We hypothesized that hypofractionation versus conventional fractionation is similar in efficacy without increased toxicity. Patients and Methods We conducted a multicenter randomized noninferiority trial in intermediate-risk prostate cancer (T1 to 2a, Gleason score ≤ 6, and prostate-specific antigen [PSA] 10.1 to 20 ng/mL; T2b to 2c, Gleason ≤ 6, and PSA ≤ 20 ng/mL; or T1 to 2, Gleason = 7, and PSA ≤ 20 ng/mL). Patients were allocated to conventional RT of 78 Gy in 39 fractions over 8 weeks or to hypofractionated RT of 60 Gy in 20 fractions over 4 weeks. Androgen deprivation was not permitted with therapy. The primary outcome was biochemical-clinical failure (BCF) defined by any of the following: PSA failure (nadir + 2), hormonal intervention, clinical local or distant failure, or death as a result of prostate cancer. The noninferiority margin was 7.5% (hazard ratio, < 1.32). Results Median follow-up was 6.0 years. One hundred nine of 608 patients in the hypofractionated arm versus 117 of 598 in the standard arm experienced BCF. Most of the events were PSA failures. The 5-year BCF disease-free survival was 85% in both arms (hazard ratio [short v standard], 0.96; 90% CI, 0.77 to 1.2). Ten deaths as a result of prostate cancer occurred in the short arm and 12 in the standard arm. No significant differences were detected between arms for grade ≥ 3 late genitourinary and GI toxicity. Conclusion The hypofractionated RT regimen used in this trial was not inferior to conventional RT and was not associated with increased late toxicity. Hypofractionated RT is more convenient for patients and should be considered for intermediate-risk prostate cancer.

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“…All cases were required to undergo real-time central RT review before the third treatment fraction. 14…”

Section: Radiation Treatmentmentioning

confidence: 99%

Randomized Trial of a Hypofractionated Radiation Regimen for the Treatment of Localized Prostate Cancer

Catton

Lukka

et al. 2017

JCO

581

433

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“…into our clinics. The techniques of treatment delivery are available in each trial's published supplemental information (1,2,14). As a practical example, in Table 3, we also provide Duke University's current organ-at-risk constraints incorporating tighter metrics than those reported in NRG 0415.…”

Section: What Can We Do Right Now?mentioning

confidence: 99%

Six Questions to Ask Before We Shorten Radiation Treatments for Intact Prostate Cancer

Bekelman

Lee

2017

International Journal of Radiation Oncology*Biology*Physics

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“…Of note, in the 45-50 Gy dose range, we did not have any RW dose objective. Moreover, only 37.4% of our patients would have satisfied a slightly relaxed objective at 46 Gy ( 30%) that was mandatory in order to be eligible for randomization within the PROFIT trial [28].…”

Section: Discussionmentioning

confidence: 99%

Refinement & validation of rectal wall dose volume objectives for prostate hypofractionation in 20 fractions

Sanguineti

Faiella

Farneti

et al. 2020

Clinical and Translational Radiation Oncology

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a b s t r a c tBackground and purpose: Dose-volume objectives for the rectum have been proposed to limit long term toxicity after moderately hypofractionated radiotherapy (MHRT) for localized prostate cancer. The purpose of the present study is to validate and possibly refine dose volume objective for the rectal wall after 20-fraction MHRT. Materials and methods: All patients treated by 20-fraction MHRT at a single Institution were identified and relative rectal wall (%RW) DVH retrieved. The endpoint of the study is the development of grade 2 + late rectal bleeding (LRB) according to a modified RTOG scale. Clinical and dosimetric predictors of LRB were investigated at both uni-and multi-variable analysis. Results: 293 patients were identified and analyzed. Of them, 35 (12%) developed the endpoint. At univariable analysis, antithrombotic drug usage (yes vs no), technique (3DCRT vs IMRT/VMAT) and several %RW DVH cut-points were significantly correlated with LRB. However, within patients treated by 3DCRT (N = 106), a bi-variable model including anti-thrombotic drug usage and selected %RW dose/volume metrics failed to identify independent dosimetric predictors of LRB. Conversely, within patients treated with intensity modulation (N = 187), the same model showed a progressively higher impact of the percent of RW receiving doses above 40 Gy. Based on this model, we were able to confirm (V32), refine (V60) and identify a novel (V50) cut-point for the %RW. Conclusion: We recommend the following dose volume objectives for the %RW in order to minimize the risk of LRB after 20-fraction MHRT: V32 50%; V50 25.8% and V60 10%.

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Prostate radiotherapy clinical trial quality assurance: How real should real time review be? (A TROG-OCOG Intergroup Project)

Cited by 12 publications

References 23 publications

Randomized Trial of a Hypofractionated Radiation Regimen for the Treatment of Localized Prostate Cancer

Randomized Trial of a Hypofractionated Radiation Regimen for the Treatment of Localized Prostate Cancer

Six Questions to Ask Before We Shorten Radiation Treatments for Intact Prostate Cancer

Refinement & validation of rectal wall dose volume objectives for prostate hypofractionation in 20 fractions

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