Evaluating the Impact of Prostate Only Versus Pelvic Radiotherapy for Pathological Node-positive Prostate Cancer: First Results from the Multicenter Phase 3 PROPER Trial

Fonteyne, Valérie; Praet, Charles Van; Ost, Piet; Bruwaene, Siska Van; Liefhooghe, Nick; Berghen, Charlien; Meerleer, Gert De; Vanneste, Ben; Verbaeys, Caroline; Verbeke, Sofie; Lumen, Nicolaas

doi:10.1016/j.euf.2022.09.005

Cited by 5 publications

(9 citation statements)

References 31 publications

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“…Preliminary results showed that, after a median follow-up of 3 years, biochemical relapse-free survival was 79% and 92% for patients who received PORT compared to WPRT, and no pelvic recurrences were seen in the WPRT group. 17 The study confirmed that, even when modern techniques are applied, WPRT comes at the cost of more acute GI toxicity. 17 …”

Section: Discussionsupporting

confidence: 52%

“… 17 The study confirmed that, even when modern techniques are applied, WPRT comes at the cost of more acute GI toxicity. 17 …”

Section: Discussionsupporting

confidence: 52%

“… 22 The first results of our prospective randomized trials also suggest an advantage for WPRT for pN1 PCa patients. 17 …”

Section: Discussionmentioning

confidence: 99%

“…Due to poor accrual, the study was closed prematurely after including 69 patients from whom dosimetric data and blood analyses were available in 64 patients. 17 …”

Section: Methodsmentioning

confidence: 99%

“…Due to poor accrual, the study was closed prematurely after including 69 patients from whom dosimetric data and blood analyses were available in 64 patients. 17 The dosimetric parameters that were analyzed for the targets and nodal areas are median dose and dose received by 98% (D98) and 2% (D02) of the volume as a surrogate for minimal dose and maximal dose, respectively. For the rectum and sigmoid colon, we report on D02 and volume of the organ receiving a biological equivalent dose in 2 Gy fractions of 40, 50, 60, and 65 Gy.…”

Section: Statistical Considerationsmentioning

confidence: 99%

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Dosimetric and Hematologic Implications of Prostate-Only Versus Whole Pelvic Radiotherapy: Results of the Multicentric Phase 3 PROPER Study

Fonteyne

Danckaert

Ost

et al. 2023

Technol Cancer Res Treat

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Objectives: The aim is to evaluate the incidental dose to the lymphatic regions in prostate-only radiotherapy (PORT) and to compare hematological outcome between PORT and whole pelvic radiotherapy (WPRT) in node-positive prostate cancer (pN1 PCa), in the era of modern radiotherapy techniques. Methods: We performed a prospective phase 3 trial in which a total of 64 pN1 PCa patients were randomized between PORT (ARM A) and WPRT (ARM B) delivered with volumetric-modulated arc therapy (VMAT). The lymph node (LN) regions were delineated separately and differences between groups were calculated using Welch t-tests. Hematological toxicity was scored according to common terminology criteria for adverse events (CTCAE) version 4.03. To evaluate differences in the evolution of red blood cell (RBC), white blood cell (WBC), and platelet count over time between PORT and WPRT, 3 linear mixed models with a random intercept for the patient was fit with model terms randomization group, study time point, and the interaction between both categorical predictors. Results: Except for dose to the obturator region, the incidental dose to the surrounding LN areas was low in ARM A. None of the patients developed severe hematological toxicity. The change in RBC from time point pre-external beam radiotherapy (EBRT) to month 3 and for WBC from time point pre-EBRT to months 3 and 12 was significantly different with ARM B showing a larger decrease. Conclusion: The incidental dose to the lymphatic areas becomes neglectable when PORT is delivered with VMAT. Hematological toxicity is very low after WPRT with VMAT and when bone marrow constraints are used for planning, although WPRT causes a decrease in RBC and WBC count over time.

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Section: Discussionsupporting

confidence: 52%

“… 17 The study confirmed that, even when modern techniques are applied, WPRT comes at the cost of more acute GI toxicity. 17 …”

Section: Discussionsupporting

confidence: 52%

“… 22 The first results of our prospective randomized trials also suggest an advantage for WPRT for pN1 PCa patients. 17 …”

Section: Discussionmentioning

confidence: 99%

“…Due to poor accrual, the study was closed prematurely after including 69 patients from whom dosimetric data and blood analyses were available in 64 patients. 17 …”

Section: Methodsmentioning

confidence: 99%

Section: Statistical Considerationsmentioning

confidence: 99%

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