Sequential Imaging of Suspicion of Prostate Cancer Reducing Overdiagnosis and Unnecessary Biopsy With Timely Diagnosis of Significant Cancer

Обзор

The goal of this clinical trial is to evaluate the safety and effectiveness of a novel diagnostic strategy for prostate cancer, in which men with a moderate risk of prostate cancer are monitored using PSA and MRI instead of immediate biopsy,. The main questions it aims to answer are: * Is it safe to delay biopsy, making sure that clinical significant prostate cancers are not often missed? * Does it reduce unnecessary biopsies and overtreatment?

Вмешательства

• Другое PSA and MRI-monitoring
  Men with PI-RADS 3 or 4 lesions and a PSA density ≤ 0.15 ng/mL² are actively monitored with PSA testing every six months and MRI annually, instead of undergoing immediate prostate biopsy.

Первичные конечные точки

• Proportion clinically significant prostate cancer missed during follow up [Срок оценки: 48 months]
• Number of clinically insignificant prostate cancer detected [Срок оценки: 48 months]
• Number of negative biopsies [Срок оценки: 48 months]

Вторичные конечные точки (5)

• Grade shifts [Срок оценки: 48 months]
• Detection of very high risk prostate cancer [Срок оценки: 48 months]
• Health-related quality of life (EPIC-26 score) [Срок оценки: 48 months]
• Estimated average cost per patient during 48-month follow-up [Срок оценки: 48 months]
• Anxiety symptomes (STAI-6 score) [Срок оценки: 48 months]

Критерии участия

Критерии включения

• Life expectancy > 10 years
• initial PSA < 20 ng/ml
• No signs of extracapsular disease on digital rectal examination
• Intermediate-risk category for suspicion of prostate cancer determined by MRI results and PSA density (PSAD): PI-RADS 3 or PI-RADS 4 with PSAD =< 0.15
• Mentally competent and able to comprehend the potential benefits and burdens of the study
• Willing to undergo the follow-up protocol for a maximum of four years
• written and signed informed consent

Критерии исключения

• Men who have previously undergone a prostate biopsy
• Men who have a prior PCa diagnosis
• using any (anti-)hormonal therapy, including 5-alpha-reductase inhibitors
• Proven germline mutation for PCa (for example: BRCA1; BRCA2)
• Secondary malignancy, besides basal cell carcinoma of the skin, for which the potential participant is receiving active treatment at the time of inclusion.
• severe claustrofobia or other conditions that make (repeat) MRI unsuitable (e.g., metal implants, pacemakers)

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

Диагностика

Центры проведения

Нидерланды · 7 центров

• Treant — Emmen
• Andros Clinics — Arnhem
• Radboud University Medical Centre — Nijmegen
• Canisius Wilhelmina Hospital — Nijmegen
• Antoni van Leeuwenhoek Hospital — Amsterdam
• Maasstad Hospital — Rotterdam
• St Antonius Hospital — Nieuwegein

Публикации

• Sweere V, de Rooij M, Kil PJM, Israel B, van Basten JPA, Boellaard TN, Graus SA, van der Heijden AG, van der Hoeven EJRJ, Klaver OS, Mertens LS, Prette JF, Roelofs LAJ, Sedelaar JPM, Snoek AM, Somford DM, Barentsz JO, Van Melick HHE, van den Bergh RCN. Sequential Imaging of Suspicion of Prostate Cancer: Reducing Overdiagnosis and Unnecessary Biopsy with Timely Diagnosis of Significant Cancer (SPRO PMID 42242939

Идентификаторы

NCT: NCT07180381 · NL-005445

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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