Dataset Information

Multiparametric magnetic resonance imaging-guided salvage radiotherapy in prostate cancer.

ABSTRACT:

Aim

To analyse the efficacy and toxicity of postprostatectomy SRT in patients with a BCR evaluated with mpMRI.

Background

Multiparametric magnetic resonance imaging (mpMRI) has the ability to detect the site of pelvic recurrence in patients with biochemical recurrence (BCR) after radical prostatectomy (RP). However, we do not know the oncological outcomes of mpMRI-guided savage radiotherapy (SRT).

Results

Local, lymph node, and pelvic bone recurrence was observed in 13, 4 and 2 patients, respectively. PSA levels were significantly lower in patients with negative mpMRI (0.4 ng/mL [0.4]) vs. positive mpMRI (2.2 ng/mL [4.1], p = 0.003). Median planning target volume doses in patients with visible vs. non-visible recurrences were 76 Gy vs. 70 Gy. Overall, mean follow-up was 41 months (6-81). Biochemical relapse-free survival (bRFS) at 3 years was 82.3% and 82.5%, respectively, for the negative and positive mpMRI groups (p = 0.800). Three-year rates of late grade ≥2 urinary and rectal toxicity were 14.8% and 1.9%, respectively; all but one patient recovered without sequelae.

Conclusion

SRT to the macroscopic recurrence identified by mpMRI is a feasible and well-tolerated option. In this study, there were no differences in bRFS between MRI-positive and MRI-negative patients, indicating effective targeting of MRI-positive lesions.

SUBMITTER: Counago F

PROVIDER: S-EPMC6700415 | biostudies-literature | 2019 Sep-Oct

REPOSITORIES: biostudies-literature

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Publications

Multiparametric magnetic resonance imaging-guided salvage radiotherapy in prostate cancer.

Couñago Felipe F Díaz Gavela Ana Aurora AA Sancho Gemma G Ortiz Irene I Marcos Francisco José FJ Recio Manuel M Fernández Julio J Cano Raquel R Jiménez Mar M Thuissard Israel J IJ Sanz-Rosa David D Castro Nováis Juan J Pardo Eduardo E Molina Yolanda Y Pérez García Hugo H Del Cerro Elia E

Reports of practical oncology and radiotherapy : journal of Greatpoland Cancer Center in Poznan and Polish Society of Radiation Oncology 20190808 5

<h4>Aim</h4>To analyse the efficacy and toxicity of postprostatectomy SRT in patients with a BCR evaluated with mpMRI.<h4>Background</h4>Multiparametric magnetic resonance imaging (mpMRI) has the ability to detect the site of pelvic recurrence in patients with biochemical recurrence (BCR) after radical prostatectomy (RP). However, we do not know the oncological outcomes of mpMRI-guided savage radiotherapy (SRT).<h4>Results</h4>Local, lymph node, and pelvic bone recurrence was observed in 13, 4 a ...[more]

PMID: 31452628

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Project description:BackgroundStereotactic body radiotherapy (SBRT) is becoming increasingly used in treating localized prostate cancer (PCa), with evidence showing similar toxicity and efficacy profiles when compared with longer courses of definitive radiation. Magnetic resonance imaging (MRI)-guided radiotherapy has multiple potential advantages over standard computed tomography (CT)-guided radiotherapy, including enhanced prostate visualization (abrogating the need for fiducials and MRI fusion), enhanced identification of the urethra, the ability to track the prostate in real-time, and the capacity to perform online adaptive planning. However, it is unknown whether these potential advantages translate into improved outcomes. This phase III randomized superiority trial is designed to prospectively evaluate whether toxicity is lower after MRI-guided versus CT-guided SBRT.MethodsThree hundred men with localized PCa will be randomized in a 1:1 ratio to SBRT using CT or MRI guidance. Randomization will be stratified by baseline International Prostate Symptom Score (IPSS) (≤15 or > 15) and prostate gland volume (≤50 cc or > 50 cc). Five fractions of 8 Gy will be delivered to the prostate over the course of fourteen days, with or without hormonal therapy and elective nodal radiotherapy (to a dose of 5 Gy per fraction) as per the investigator's discretion. The primary endpoint is the incidence of physician-reported acute grade ≥ 2 genitourinary (GU) toxicity (during the first 90 days after SBRT), as assessed by the CTCAE version 4.03 scale. Secondary clinical endpoints include incidence of acute grade ≥ 2 gastrointestinal (GI) toxicity, 5-year cumulative incidences of physician-reported late grade ≥ 2 GU and GI toxicity, temporal changes in patient-reported quality of life (QOL) outcomes, 5-year biochemical recurrence-free survival and the proportion of fractions of MRI-guided SBRT in which online adaptive radiotherapy is used.DiscussionThe MIRAGE trial is the first randomized trial comparing MRI-guided with standard CT-guided SBRT for localized PCa. The primary hypothesis is that MRI-guided SBRT will lead to an improvement in the cumulative incidence of acute grade ≥ 2 GU toxicity when compared to CT-guided SBRT. The pragmatic superiority design focused on an acute toxicity endpoint will allow an early comparison of the two technologies.Trial registrationClinicaltrials.gov identifier: NCT04384770. Date of registration: May 12, 2020. https://clinicaltrials.gov/ct2/show/NCT04384770 PROTOCOL VERSION: Version 2.1, Aug 28, 2020.

Project description:PurposeThe clinical utility of multiparametric magnetic resonance imaging (mpMRI) for the detection and localization of prostate cancer (PCa) has been evaluated and validated. However, the implementation of mpMRI into the clinical practice remains some burden of cost and availability for patients and society. We aimed to predict the results of prostate mpMRI using the clinical parameters and multivariable model to reduce unnecessary mpMRI scans.MethodsWe retrospectively identified 784 men who underwent mpMRI scans and subsequent prostate biopsy between 2016 and 2020 according to the inclusion criterion. The cohort was split into a training cohort of 548 (70%) patients and a validation cohort of 236 (30%) patients. Clinical parameters including age, prostate-specific antigen (PSA) derivates, and prostate volume (PV) were assessed as the predictors of mpMRI results. The mpMRI results were divided into groups according to the reports: "negative", "equivocal", and "suspicious" for the presence of PCa.ResultsUnivariate analysis showed that the total PSA (tPSA), free PSA (fPSA), PV, and PSA density (PSAD) were significant predictors for suspicious mpMRI (P < 0.05). The PSAD (AUC = 0.77) and tPSA (AUC = 0.74) outperformed fPSA (AUC = 0.68) and PV (AUC = 0.62) in the prediction of the mpMRI results. The multivariate model (AUC = 0.80) had a similar diagnostic accuracy with PSAD (P = 0.108), while higher than tPSA (P = 0.024) in predicting the mpMRI results. The multivariate model illustrated a better calibration and substantial improvement in the decision curve analysis (DCA) at a threshold above 20%. Using the PSAD with a 0.13 ng/ml2 cut-off could spare the number of mpMRI scans by 20%, keeping a 90% sensitivity in the prediction of suspicious MRI-PCa and missing three (3/73, 4%) clinically significant PCa cases. At the same sensitivity level, the multivariate model with a 32% cut-off could spare the number of mpMRI scans by 27%, missing only one (1/73, 1%) clinically significant PCa case.ConclusionOur multivariate model could reduce the number of unnecessary mpMRI scans without comprising the diagnostic ability of clinically significant PCa. Further prospective validation is required.

Project description:ImportanceMagnetic resonance imaging (MRI) guidance offers multiple theoretical advantages in the context of stereotactic body radiotherapy (SBRT) for prostate cancer. However, to our knowledge, these advantages have yet to be demonstrated in a randomized clinical trial.ObjectiveTo determine whether aggressive margin reduction with MRI guidance significantly reduces acute grade 2 or greater genitourinary (GU) toxic effects after prostate SBRT compared with computed tomography (CT) guidance.Design, setting, and participantsThis phase 3 randomized clinical trial (MRI-Guided Stereotactic Body Radiotherapy for Prostate Cancer [MIRAGE]) enrolled men aged 18 years or older who were receiving SBRT for clinically localized prostate adenocarcinoma at a single center between May 5, 2020, and October 1, 2021. Data were analyzed from January 15, 2021, through May 15, 2022. All patients had 3 months or more of follow-up.InterventionsPatients were randomized 1:1 to SBRT with CT guidance (control arm) or MRI guidance. Planning margins of 4 mm (CT arm) and 2 mm (MRI arm) were used to deliver 40 Gy in 5 fractions.Main outcomes and measuresThe primary end point was the incidence of acute (≤90 days after SBRT) grade 2 or greater GU toxic effects (using Common Terminology Criteria for Adverse Events, version 4.03 [CTCAE v4.03]). Secondary outcomes included CTCAE v4.03-based gastrointestinal toxic effects and International Prostate Symptom Score (IPSS)-based and Expanded Prostate Cancer Index Composite-26 (EPIC-26)-based outcomes.ResultsBetween May 2020 and October 2021, 156 patients were randomized: 77 to CT (median age, 71 years [IQR, 67-77 years]) and 79 to MRI (median age, 71 years [IQR, 68-75 years]). A prespecified interim futility analysis conducted after 100 patients reached 90 or more days after SBRT was performed October 1, 2021, with the sample size reestimated to 154 patients. Thus, the trial was closed to accrual early. The incidence of acute grade 2 or greater GU toxic effects was significantly lower with MRI vs CT guidance (24.4% [95% CI, 15.4%-35.4%] vs 43.4% [95% CI, 32.1%-55.3%]; P = .01), as was the incidence of acute grade 2 or greater gastrointestinal toxic effects (0.0% [95% CI, 0.0%-4.6%] vs 10.5% [95% CI, 4.7%-19.7%]; P = .003). Magnetic resonance imaging guidance was associated with a significantly smaller percentage of patients with a 15-point or greater increase in IPSS at 1 month (6.8% [5 of 72] vs 19.4% [14 of 74]; P = .01) and a significantly reduced percentage of patients with a clinically significant (≥12-point) decrease in EPIC-26 bowel scores (25.0% [17 of 68] vs 50.0% [34 of 68]; P = .001) at 1 month.Conclusions and relevanceIn this randomized clinical trial, compared with CT-guidance, MRI-guided SBRT significantly reduced both moderate acute physician-scored toxic effects and decrements in patient-reported quality of life. Longer-term follow-up will confirm whether these notable benefits persist.Trial registrationClinicalTrials.gov Identifier: NCT04384770.

Dataset Information

Multiparametric magnetic resonance imaging-guided salvage radiotherapy in prostate cancer.

Aim

Background

Results

Conclusion

Publications

Multiparametric magnetic resonance imaging-guided salvage radiotherapy in prostate cancer.

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