Focal Versus Whole Gland High Dose-Rate Brachytherapy (HDR-BT) Boost to External Beam Radiotherapy in Localized Prostate Cancer: A Phase 2 Randomized Trial

Официальное название

FOcal Versus Whole Gland High Dose-Rate Brachytherapy (HDR-BT) Boost With ExternAl Beam Radiotherapy in LocalizeD Prostate Cancer: A Phase 2 Randomized Trial [FORWARD]

Обзор

This project aims to compare the changes in the urinary quality of life (QoL) following focal high dose-rate brachytherapy (HDR-BT) boost to stereotactic ablative radiotherapy (SABR), compared to standard whole gland HDR-BT boost, in the treatment of men diagnosed with intermediate- and high-risk prostate cancer, with have an identifiable DIL on mpMRI.

Вмешательства

• Лучевая терапия Standard Arm: Whole Gland High Dose Rate Brachytherapy Boost
  Whole gland high dose rate brachytherapy (15 Gray/1 fraction) plus stereotactic ablative radiotherapy to the prostate +/- pelvis (25 Gray/5 fractions). Androgen deprivation therapy 6 to 24 months (physician discretion).
• Лучевая терапия Experimental Arm: Focal High Dose Rate Brachytherapy Boost
  Focal high dose rate brachytherapy boost to the dominant intraprostatic lesion (15 Gray/1 fraction) plus stereotactic ablative radiotherapy to the prostate (30 Gray/5 fractions) +/- the pelvis (25 Gray/5 fractions). Androgen deprivation therapy 6 to 24 months (physician discretion).

Первичные конечные точки

• Changes in Urinary Quality of Life at 24 Months Measured by the Expanded Prostate Index Composite (EPIC-26) Questionnaire [Срок оценки: From enrollment to 24 months post radiation therapy]

Вторичные конечные точки (6)

• Acute Changes in Urinary, Bowel, and Sexual Quality of Life [Срок оценки: Less than or equal to 6 months post radiation therapy]
• Long Term Changes in Bowel and Sexual Quality of Life Measured by Expanded Prostate Index Composite (EPIC-26) Questionnaire [Срок оценки: From enrollment to 24 months post radiation therapy]
• Acute and Chronic Physician-Reported Toxicity Using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 [Срок оценки: From enrollment to 24 months post radiation therapy]
• Prostate Specific Antigen (PSA) at 4 years [Срок оценки: 4 years post radiation therapy]
• Biochemical Control Measure by Prostate Specific Antigen (PSA) Levels [Срок оценки: Enrollment to 5 years post radiation therapy]
• Participant reported Symptoms Measured by the Patient Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE) [Срок оценки: From enrollment to 24 months post radiation therapy]

Критерии участия

Критерии включения

• Histologically confirmed diagnosis of adenocarcinoma of the prostate
• Eastern Co-Operative Oncology Group (ECOG) 0-2
• Intermediate and high-risk disease with localized unfavorable features:

• defined as clinical stage tumor cT1 or cT2a, International Society of Urological Pathology (ISUP) grade group 2-4 in less than or equal to 50% of the cores, unilateral extracapsular extension (ECE), prostate specific antigen (PSA) less than or equal to 20 ng/mL
• corresponding to an Identified dominant intraprostatic lesion (DIL) on multiparametric magnetic resonance imaging (mpMRI) Prostate Imaging Reporting and Data System score (PI-RADs 3-5)
• Prostate volume less than or equal to 60 cc is recommended. Transrectal ultrasound (TRUS) and magnetic resonance imaging (MRI) are accepted to assess prostate volume. Patients with a prostate volume between 60 and 80 cc can be included if the International Prostate Symptom Score (IPSS) is less than 15 and brachytherapy is deemed feasible by the treating physician.

Критерии исключения

• Contraindications to mpMRI
• Documented nodal or distant metastases
• Previous pelvic radiotherapy
• Recent transurethral resection of prostate (less than or equal to 6 months), previous prostatectomy or high-intensity focused ultrasound (HIFU)
• Poor baseline urinary function: International Prostate Symptom Score (IPSS) greater than 19
• Connective tissue disease or inflammatory bowel disease
• Patients deemed unsuitable for general anaesthetic by the Anaesthesia Department
• Patient is unable to lie flat long enough for the Radiation Therapy (RT) Simulation and Treatment

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• London Health Sciences Centre, Verspeeten Family Cancer Centre — London

Идентификаторы

NCT: NCT07300566 · FORWARD - ReDA 16623

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗