PSMA-PET to Guide Prostatectomy

Официальное название

PSMA-PET to Guide Prostatectomy: A Randomized Trial

Обзор

In this study, 196 patients will be randomized 1:1 to either having only the standard of care MRI prior to surgery versus having the standard of care MRI and the PSMA PET scan. PET (and MRI) findings will be validated against whole mount pathology. Pre-surgical imaging findings will also be evaluated in the context of affecting subsequent surgical plans and impacting actual patient outcomes.

Вмешательства

• Диагностический тест PSMA-PET and SOC MRI
  60 min continuous acquisition of PET data after 3-6 mCI injection of \[68Ga\]P16-093 followed by contrast-CT
• Диагностический тест SOC MRI
  Standard of care MRI

Первичные конечные точки

• IIEF-EF sub scale score [Срок оценки: 1 month]
• IIEF-EF sub scale score [Срок оценки: 3 months]
• IIEF-EF sub scale score [Срок оценки: 6 months]
• IIEF-EF sub scale score [Срок оценки: 12 months]
• IIEF-EF sub scale score [Срок оценки: 18 months]

Вторичные конечные точки (9)

• Change in treatment plan [Срок оценки: 1 month]
• Ratio of positive surgical margins to nerve bundles spared [Срок оценки: 1 month]
• EPE detection [Срок оценки: 1 month]
• Incontinence bother [Срок оценки: 18 months]
• Incontinence: using 0-1 pads per day [Срок оценки: 18 months]
• Urgency/frequency [Срок оценки: 18 months]
• Erectile dysfunction: ability to achieve erection sufficient for penetration [Срок оценки: 18 months]
• Overall mental and physical health [Срок оценки: 18 months]
• Surgical margins [Срок оценки: 1 month]

Критерии участия

Критерии включения

• Significant prostate cancer:

Gleason 3+4 ≥1 core with pattern 4 ≥20%

Gleason 3+4 ≥1 core with ≥50% total involvement of core OR ≥3 cores of Gleason 3+4 OR

NCCN unfavorable intermediate risk OR

Any Gleason 4+3, 4+4, 4+5, 5+4, or 5+5 AND

• Baseline sexual function (IIEF-EF > 17): No erectile dysfunction OR mild-to- moderate erectile dysfunction (International Index of Erectile Function Domain ≥ 17) AND
• The patient desires to maintain erections following treatment
• Planned to undergo a standard of care MRI or recently completed standard of care MRI within 6 months of scheduled date of surgery. Note: For subjects whose SOC MRI is not within 6 months or not 3Tesla, they may be enrolled in the study and the MRI will be repeated as a research study. The research MRI will not be billed to the subject's insurance, but will be scheduled at IU ORI, at no cost to study participant.
• Planned Prostatectomy candidate per treating oncologist with prostatectomy planned within 90 days of consent.

Критерии исключения

• Participation in another investigational trial involving research exposure to ionizing radiation concurrently or within 30 days.
• Does not meet safety criteria for MRI scan (e.g. metal implant that is not allowed, since MRI is required for comparison).
• Significant acute or chronic medical, neurologic, or illness in the subject that, in the judgment of the Principal Investigator, could compromise subject safety, limit the ability to complete the study, and/or compromise the objectives of the study.

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

Простое слепое

Основная цель

Диагностика

Центры проведения

США · 1 центр

• Goodman Hall, Indiana Institute for Biomedical Imaging Sciences, Indiana University School — Indianapolis

Идентификаторы

NCT: NCT05381103 · IU_CLN02_EPE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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