Evaluation of Tumor Control Based on Serial Multiparametric MRI and Post-Treatment Biopsies For Patients Treated With Dose Intensification to the Dominant Intra-Prostatic Lesion (DIL) Using Ultra-Hypofractionated, MR-Guided Radiotherapy

Официальное название

Evaluation of Tumor Control Based on Serial Multiparametric MRI and Post-Treatment Biopsies For Patients Treated With Dose Intensification to the Dominant Intra-Prostatic Lesion (DIL) Using Ultra-Hypofractionated, MR-Guided Radiotherapy (TUMORNATOR I)

Обзор

The purpose of this study is to assess the impact of this MR-guided radiotherapy on tumor control of the dominant intraprostatic lesion among patients with intermediate risk prostate cancer. This study of Radiotherapy to the Prostate and Dominant Lesion Using Ultra-Hypofractionated, MR-adaptive Radiation Therapy aims to evaluate tumor control after definitive ultra-hypofractionated external beam radiation therapy (including a simultaneously delivered high-dose boost to a dominant lesion as detected on prostate magnetic resonance imaging (MRI)) in patients with intermediate-risk prostate cancer. This will incorporate the use of multiparametric MRI for target segmentation and the use of the MR-linac with adaptive radiation planning to treat the prostate gland, incorporating a dose boost to the dominant intraprostatic lesion (DIL) that is visible on T2-weighted and diffusion-weighted imaging and de-escalation of dose to the remainder of the prostate.

Вмешательства

• Лучевая терапия 1.5 T Elekta Unity MR-Linac system
  Patients will receive 9 Gy/fraction (45 Gy total) for five fractions to the DIL, while the remainder of the prostate will be treated to 30 Gy in 5 fractions.
• Устройство Hydrogel rectal spacer (SpaceOAR)
  A rectal spacer will be placed one week prior to simulation to achieve a separation of approximately 1 cm between the prostate and anterior rectal wall to further minimize rectal toxicity in these patients. The hydrogel will remain in the body for about 12 weeks.

Первичные конечные точки

• Negative biopsy rate 24 months post-treatment [Срок оценки: 24 months post-treatment]
• Serious toxicity rate 24 months post-treatment [Срок оценки: 24 months post-treatment]

Вторичные конечные точки (11)

• Prostate Specific Antigen (PSA) relapse rate at 24 months post-treatment [Срок оценки: 24 months post-treatment]
• Proportion of patients with radiation-induced response in the dominant prostatic lesion 6 months post treatment [Срок оценки: 6 months post-treatment]
• Proportion of patients with radiation-induced response in the dominant prostatic lesion 24 months post treatment [Срок оценки: 24 months post-treatment]
• Change in International Prostate Symptom Score (I-PSS) [Срок оценки: Baseline, Month 3]
• Change in International Prostate Symptom Score (I-PSS) [Срок оценки: Baseline, Month 6]
• Change in International Prostate Symptom Score (I-PSS) [Срок оценки: Baseline, Month 12-18]
• Change in International Index of Erectile Function (IIEF) score [Срок оценки: Baseline, Month 3]
• Change in International Index of Erectile Function (IIEF) score [Срок оценки: Baseline, Month 6]
• Change in International Index of Erectile Function (IIEF) score [Срок оценки: Baseline, Month 12-18]
• Change in genomic classifier (GC) Decipher score [Срок оценки: Baseline, 6 months post-treatment]
• Change in GC Decipher score [Срок оценки: Baseline, 24 months post-treatment]

Критерии участия

Критерии включения

• Intermediate-risk prostate cancer patients will be eligible for this study. Risk groups will be assigned as per National Comprehensive Cancer Network (NCCN) guidelines. Intermediate-risk patients will be defined as:

• PSA 10-20 ng/ml or
• Gleason score = 7 or
• Clinical stage T2b/T2c (T2b: the tumor has spread to more than one-half of one side of the prostate, but not to both sides. T2c: the cancer has invaded both sides of the prostate)
• Age > 18
• Karnofsky Performance Status (KPS) > 80
• Prostate size < 90 cc
• Presence of a T2-visible prostatic lesion with maximum dimension of ≥ 0.5 cm and no more than two additional disease foci with a documented Prostate Imaging Reporting and Data System (PIRADS) 4-5 lesion
• MRI findings: Lesion may contact the capsular edge, possible extracapsular extension (ECE) permitted
• International Prostate Symptom Score < 18
• Satisfy all MRI screening criteria and be willing to fill out the standard MRI screening form

Критерии исключения

• Gleason score >7
• PSA >20 ng/mL
• Prior or concurrent androgen deprivation therapy for prostate cancer
• MRI findings: suspicious for/probable ECE
• MRI findings: >2 disease foci identifiable
• Evidence of metastatic disease on bone scan or MRI/CT
• MRI ineligibility due to: the presence of a cardiac pacemaker, defibrillator, or other implanted metallic or electronic device which is considered MR unsafe; severe claustrophobia; inability to lie flat for the duration of the study; etc.
• Metallic implant or device in the pelvis that might distort the local magnetic field and compromise quality of mp-MRI
• Lateral pelvic separation greater than 50 cm and/or anterior-posterior separation greater than 35 cm which are incompatible with MR for Calculating ATtenuation (MRCAT) reconstruction
• Contra-indications to receiving gadolinium contrast
• KPS < 80
• Pelvic or Prostate MRI or CT (MRI preferred) evidence of radiographic T3, T4, or N1 disease
• Prior history of transurethral resection of the prostate
• Prior history of urethral stricture
• Prior history of pelvic irradiation
• History of inflammatory bowel disease
• Unable to give informed consent
• Unable to complete quality of life questionnaires
• Abnormal complete blood count, including any of the following:

• Platelet count less than 75,000/ml
• Hb level less than 10 gm/dl
• White blood cell (WBC) less than 3.5/ml
• Abnormal renal function tests (creatinine > 1.5)

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

США · 1 центр

• NYU Langone Health — New York

Идентификаторы

NCT: NCT06542757 · 23-01590

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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