Partial Prostate Salvage High Dose Rate Brachytherapy

Официальное название

High Dose Rate Partial Prostate Brachytherapy as Salvage Treatment for Local Failures After Previous External Beam Radiotherapy

Обзор

A dose-response relationship for radiation in the management of prostate cancer is well established. Local recurrence of prostate cancer after external beam radiotherapy occurs in at least 40% of patients treated because of inability to deliver sufficient dose through external beam techniques. These patients respond well to re-irradiation using brachytherapy with about 50% of selected patients remaining free of recurrence 5 years after salvage. Advanced imaging using multiparametric Magnetic Resonance Imaging (mpMRI) allows identification of the site of recurrence, permitting partial prostate salvage brachytherapy. There is extensive literature on Low Dose Rate salvage brachytherapy but less on High Dose Rate.

Подробное описание

Appropriately selected patients with histologically documented recurrence 3 years or more after initial external beam radiotherapy will undergo mpMRI for identification of the site of recurrence. A planning transrectal ultrasound (TRUS) will be obtained for fusion with the mpMRI and transposition of the target volume (GTV=gross tumor volume). A margin of 4.5 cm will be added to the GTV to create a focal planning target volume (PTV). The margin may be cropped at the interface with critical organs. Two fractions of HDR brachytherapy will be delivered, each from a single implant, 2 weeks apart. Following treatment patients will be monitored for toxicity and quality of life using the Expanded Prostate cancer Index (EPIC) questionnaire as well as the International Prostate Symptom score. Efficacy will be evaluated by monitoring the Prostate Specific Antigen (PSA) and if PSA is rising during follow-up, PSMA PET will be ordered when clinically indicated..

Вмешательства

• Лучевая терапия HDR partial prostate brachytherapy
  temporary radioactive implant

Первичные конечные точки

• Late adverse gastrointestinal or genitourinary events grade 3 or higher [Срок оценки: 3-60 months]

Вторичные конечные точки (7)

• Late Quality of Life [Срок оценки: 3-60 months]
• Late lower urinary tract symptoms [Срок оценки: 3-60 months]
• Acute grade 3 or higher gastrointestinal or genitourinary adverse events [Срок оценки: 0-3 months]
• Acute Quality of Life changes [Срок оценки: 0-3 months]
• Acute lower urinary symptoms [Срок оценки: 0-3 months]
• Biochemical disease free survival [Срок оценки: 60 months]
• Number of participants with site of failure determined by PSMA PET Scan at the time of rising PSA. [Срок оценки: 2 years]

Критерии участия

Критерии включения

• Age >45 and Life expectancy >10 years
• Previous External Beam Radiotherapy (EBRT) or LDR brachytherapy w
• > 3 year interval since EBRT or LDR Brachytherapy
• No late toxicity from prior EBRT ≥ grade 2
• PSA > nadir + 2 ng/ml and < 10 ng/ml
• PSA Doubling time > 6 months
• Radiographic evidence corresponding with site of recurrence in an under-dosed or untreated site. The recurrence should correspond to the site of original disease or be located in the seminal vesical +/- adjacent prostate as only area of recurrence (i.e. unifocal recurrence).
• Per Investigator, recurrence is suitable for implant with HDR brachytherapy and patient is suitable for procedure under anesthesia, spinal or general.
• Negative staging of the abdomen/pelvis and bones.
• Willing to provide informed consent

Критерии исключения

• Not compliant with criteria above
• Unable to give informed consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• BCCA Center for the Southern Interior — Kelowna

Публикации

• Arrayeh E, Westphalen AC, Kurhanewicz J, Roach M 3rd, Jung AJ, Carroll PR, Coakley FV. Does local recurrence of prostate cancer after radiation therapy occur at the site of primary tumor? Results of a longitudinal MRI and MRSI study. Int J Radiat Oncol Biol Phys. 2012 Apr 1;82(5):e787-93. doi: 10.1016/j.ijrobp.2011.11.030. Epub 2012 Feb 11. PMID 22331003
• Banerjee R, Park SJ, Anderson E, Demanes DJ, Wang J, Kamrava M. From whole gland to hemigland to ultra-focal high-dose-rate prostate brachytherapy: A dosimetric analysis. Brachytherapy. 2015 May-Jun;14(3):366-72. doi: 10.1016/j.brachy.2014.12.007. Epub 2015 Feb 10. PMID 25680768
• Crook J, Ots A, Gaztanaga M, Schmid M, Araujo C, Hilts M, Batchelar D, Parker B, Bachand F, Milette MP. Ultrasound-planned high-dose-rate prostate brachytherapy: dose painting to the dominant intraprostatic lesion. Brachytherapy. 2014 Sep-Oct;13(5):433-41. doi: 10.1016/j.brachy.2014.05.006. Epub 2014 Jun 20. PMID 24958556
• Da Rosa MR, Milot L, Sugar L, Vesprini D, Chung H, Loblaw A, Pond GR, Klotz L, Haider MA. A prospective comparison of MRI-US fused targeted biopsy versus systematic ultrasound-guided biopsy for detecting clinically significant prostate cancer in patients on active surveillance. J Magn Reson Imaging. 2015 Jan;41(1):220-5. doi: 10.1002/jmri.24710. Epub 2014 Jul 21. PMID 25044935
• Mason J, Al-Qaisieh B, Bownes P, Thwaites D, Henry A. Dosimetry modeling for focal high-dose-rate prostate brachytherapy. Brachytherapy. 2014 Nov-Dec;13(6):611-7. doi: 10.1016/j.brachy.2014.06.007. Epub 2014 Jul 29. PMID 25085456
• Rose JN, Crook JM, Pickles T, Keyes M, Morris WJ. Salvage low-dose-rate permanent seed brachytherapy for locally recurrent prostate cancer: Association between dose and late toxicity. Brachytherapy. 2015 May-Jun;14(3):342-9. doi: 10.1016/j.brachy.2015.01.002. Epub 2015 Feb 26. PMID 25727178

Идентификаторы

NCT: NCT03246802 · H17-01641

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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