A Multicenter Phase 2 study of Hypofractionated Stereostatic Boost in Intermediate Risk Prostate Carcinoma: A 5-Year Analysis of the CKNO-PRO Trial

Pasquier, David; Peiffert, D.; Nickers, Philippe; Maingon, P.; Pommier, P.; Lacornerie, T.; Martinage, Geoffrey; Tresch, Emmanuelle; Lartigau, Éric

doi:10.1016/j.ijrobp.2019.09.039

Cited by 13 publications

(10 citation statements)

References 19 publications

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“…Results of the OABSS questionnaire indicated that the majority of patients (88%) had mild urinary symptoms with an average value of 3.2 (range, 1-5). According to the IPSS questionnaire, 27% of patients had mild symptoms with an average score of 5 (range, 4-6), and the majority of patients (62%) demonstrated moderate symptoms with an average score of 12.8 (range, [8][9][10][11][12][13][14][15][16][17][18][19]. There was no statistically significant difference between 18 Gy and 21 Gy arms, except in baseline quality of life, which included more patients who answered "delighted" in 18 Gy arm.…”

Section: Resultsmentioning

confidence: 99%

“…Several studies evaluated SBRT boost using various modalities after EBRT, and their results are summarized in Table 3 [ 7 – 12 , 17 , 18 ]. Except for two studies, the majority of studies utilized CyberKnife as a modality for the SBRT boost.…”

Section: Discussionmentioning

confidence: 99%

“…While several retrospective studies have explored the feasibility of the CyberKnife boost, they included patients in different risk groups and treated patients with various dose regimens. In addition, radiation fields and androgen deprivation therapy schedules (18-21 Gy/2-3 fractions) also varied [7][8][9][10][11][12]. A 5-year analysis of a prospective phase II CKNO-PRO trial that assessed Cyber-Knife boost (18 Gy/3 fractions) followed by conventional EBRT to prostate and seminal vesicles in intermediaterisk prostate cancer was recently published [12].…”

Section: Introductionmentioning

confidence: 99%

“…In addition, radiation fields and androgen deprivation therapy schedules (18–21 Gy/2–3 fractions) also varied [ 7 – 12 ]. A 5-year analysis of a prospective phase II CKNO-PRO trial that assessed CyberKnife boost (18 Gy/3 fractions) followed by conventional EBRT to prostate and seminal vesicles in intermediate-risk prostate cancer was recently published [ 12 ]. All patients did not receive androgen deprivation therapy (ADT).…”

Section: Introductionmentioning

confidence: 99%

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Phase I/IIa trial of androgen deprivation therapy, external beam radiotherapy, and stereotactic body radiotherapy boost for high-risk prostate cancer (ADEBAR)

et al. 2020

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Background To evaluate the clinical outcomes of combination of androgen deprivation therapy (ADT), whole pelvic radiotherapy (WPRT), and stereotactic body radiotherapy (SBRT) boost in high-risk prostate cancer patients. Methods This prospective phase I/IIa study was conducted between 2016 and 2017. Following WPRT of 44 Gy in 20 fractions, patients were randomized to two boost doses, 18 Gy and 21 Gy, in 3 fractions using the Cyberknife system. Primary endpoints were incidences of acute toxicities and short-term biochemical recurrence-free survival (BCRFS). Secondary endpoints included late toxicities and short-term clinical progression-free survival (CPFS). Results A total of 26 patients were enrolled. Twelve patients received a boost dose of 18 Gy, and the rest received 21 Gy. The Median follow-up duration was 35 months. There were no grade ≥ 3 genitourinary (GU) or gastrointestinal (GI) toxicities. Sixty-one and 4% of patients experienced grade 1–2 acute GU and GI toxicities, respectively. There were 12% late grade 1–2 GU toxicities and 8% late grade 1–2 GI toxicities. Patient-reported outcomes of urinary symptoms were aggravated after WPRT and SBRT boost. However, they resolved at 1 month and returned to the baseline level at 4 months. Three-year BCRFS was 88.1%, and CPFS was 92.3%. Conclusions The present study protocol demonstrated that the combination of ADT, WPRT, and SBRT boosts for high-risk prostate cancer is safe and feasible, and may reduce total treatment time to 5 weeks. Boost dose of 21 Gy in 3 fractions seems appropriate. Trial registration ClinicalTrials.gov, ID; NCT03322020 - Retrospectively registered on 26 October 2017.

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Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Phase I/IIa trial of androgen deprivation therapy, external beam radiotherapy, and stereotactic body radiotherapy boost for high-risk prostate cancer (ADEBAR)

et al. 2020

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“…Advancements in imaging and treatment techniques including the use of magnetic resonance imaging (MRI), spacer gel to move the rectum away from the prostate [13], prostate fiducials for target localization, and intrafraction image guidance [14] have all paved the way for ultrahypofractionated SBXT. Several single-institution experiences using SBXT as a boost for intermediate-and high-risk prostate cancer have demonstrated favorable biochemical control [15][16][17][18][19][20][21][22][23][24]. However, the differences in dose distribution, compared to PB, and its radiobiological impact raise concern regarding the long-term efficacy of this approach.…”

Section: Introductionmentioning

confidence: 99%

Simulation of an HDR “Boost” with Stereotactic Proton versus Photon Therapy in Prostate Cancer: A Dosimetric Feasibility Study

Remick

Sabouri

Zhu

et al. 2021

International Journal of Particle Therapy

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Purpose/Objectives To compare the dose escalation potential of stereotactic body proton therapy (SBPT) versus stereotactic body photon therapy (SBXT) using high-dose rate prostate brachytherapy (HDR-B) dose-prescription metrics. Patients and Methods Twenty-five patients previously treated with radiation for prostate cancer were identified and stratified by prostate size (≤ 50cc; n = 13, > 50cc; n = 12). Initial CT simulation scans were re-planned using SBXT and SBPT modalities using a prescription dose of 19Gy in 2 fractions. Target coverage goals were designed to mimic the dose distributions of HDR-B and maximized to the upper limit constraint for the rectum and urethra. Dosimetric parameters between SBPT and SBXT were compared using the signed-rank test and again after stratification for prostate size (≤ 50cm3 and >50cm3) using the Wilcoxon rank test. Results Prostate volume receiving 100% of the dose (V100) was significantly greater for SBXT (99%) versus SBPT (96%) (P ≤ 0.01), whereas the median V125 (82% vs. 73%, P < 0.01) and V200 (12% vs. 2%, P < 0.01) was significantly greater for SBPT compared to SBXT. Median V150 was 49% for both cohorts (P = 0.92). V125 and V200 were significantly correlated with prostate size. For prostates > 50cm3, V200 was significantly greater with SBPT compared to SBXT (14.5% vs. 1%, P = 0.005), but not for prostates 50cm3 (9% vs 4%, P = 0.11). Median dose to 2cm3 of the bladder neck was significantly lower with SBPT versus SBXT (9.6 Gy vs. 14 Gy, P < 0.01). Conclusion SBPT and SBXT can be used to simulate an HDR-B boost for locally advanced prostate cancer. SBPT demonstrated greater dose escalation potential than SBXT. These results are relevant for future trial design, particularly in patients with high risk prostate cancer who are not amenable to brachytherapy.

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Phase II prospective trial “Give Me Five” short-term high precision radiotherapy for early prostate cancer with simultaneous boost to the dominant intraprostatic lesion: the impact of toxicity on quality of life (AIRC IG-13218)

et al. 2020

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A Multicenter Phase 2 study of Hypofractionated Stereostatic Boost in Intermediate Risk Prostate Carcinoma: A 5-Year Analysis of the CKNO-PRO Trial

Cited by 13 publications

References 19 publications

Phase I/IIa trial of androgen deprivation therapy, external beam radiotherapy, and stereotactic body radiotherapy boost for high-risk prostate cancer (ADEBAR)

Phase I/IIa trial of androgen deprivation therapy, external beam radiotherapy, and stereotactic body radiotherapy boost for high-risk prostate cancer (ADEBAR)

Simulation of an HDR “Boost” with Stereotactic Proton versus Photon Therapy in Prostate Cancer: A Dosimetric Feasibility Study

Phase II prospective trial “Give Me Five” short-term high precision radiotherapy for early prostate cancer with simultaneous boost to the dominant intraprostatic lesion: the impact of toxicity on quality of life (AIRC IG-13218)

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