Prospective Multi-centre Randomised Trial of the Additive Diagnostic Value of PSMA PET in Men With Negative/Equivocal MRI in the Diagnosis of Significant Prostate Cancer
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 660
- 试验地点
- 6
- 主要终点
- Presence of sPCa on prostate biopsy
研究概览
简要总结
This clinical trial will evaluate PSMA PET additive value for significant prostate cancer (sPCa) diagnosis in men with negative/equivocal MRI
详细描述
This open label, phase III, multi-centre, randomised trial with a non-inferiority objective will evaluate the additive diagnostic value of PSMA PET for men with negative/equivocal MRI in the diagnosis of significant prostate cancer. Patients with a clinical suspicion of prostate cancer with PI-RADS 2 or 3 on MRI, meeting all the inclusion and none of the exclusion criteria will be randomised into experimental and control arms. Patients in the experimental arm would be subjected to Pelvic PSMA PET/CT, wherein the PSMA negative patients would not undergo biopsy as opposed to PSMA positive patients who will be subjected to Transperineal targeted prostate biopsy. Whereas patients in the control arm will only receive Standard of Care (SOC) with no additional imaging (PSMA PET) and will undergo Transperineal template prostate biopsy. The co-primary objectives are to assess (1) the percentage of men with sPCa in the experimental arm (transperineal targeted biopsy) compared to the control arm (transperineal template biopsy) defined as the presence of a single biopsy core indicating disease Gleason score (GS) 3+4(>10%)=7, grade group (GG) 2, and (2) the percentage of men who avoid transperineal prostate biopsy between both arms. The secondary objectives include determining the percentage of clinically insignificant PCa on targeted biopsy (experimental arm) versus transperineal template biopsy (control arm); estimating the difference in complications from transperineal prostate biopsy between both arms; the health economics impact between the experimental and control arms; estimating the mean difference between both arms in change from baseline in health-related quality of life (QoL); estimating the mean difference between both arms at each time point in generalised anxiety and cancer worry.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients must meet all the following criteria for study entry:
- •Males aged ≥ 18 years at the time of consent
- •No previously diagnosed prostate cancer
- •No previous prostate biopsy
- •Having undergone MRI within 9 months prior to randomisation and meet one of the following criteria:
- •PI-RADS 2 AND ≥1 red flag defined as:
- •PSA density >0.1
- •Abnormal DRE
- •Strong family history (1 first degree relative or ≥2 second degree)
- •BRCA mutation
- •PSA doubling time <36 months
- •PSA velocity >0.75/year
- •PI-RADS 3
- •Intention for prostate biopsy
- •Willing and able to comply with all study requirements
排除标准
- •Patients who meet any of the following criteria will be excluded from study entry:
- •Having a PSA >20ng/ml
- •Having ≥ cT3 on DRE
- •Significant morbidity that, in the judgement of the investigator, would limit compliance with study protocol
研究组 & 干预措施
Experimental
Pelvic PSMA PET ± transperineal targeted prostate biopsy
干预措施: PSMA PET/CT (Diagnostic Test)
Experimental
Pelvic PSMA PET ± transperineal targeted prostate biopsy
干预措施: Transperineal targeted prostate biopsy (Procedure)
Control
No pelvic PSMA PET + transperineal template prostate biopsy
干预措施: Transperineal template prostate biopsy (Procedure)
结局指标
主要结局
Presence of sPCa on prostate biopsy
时间窗: When histology results are available, at an expected average of 14 days post-biopsy
sPCa defined as Gleason score 3+4(\>10%)=7, Grade group 2 Patients without biopsy (negative PSMA PET) are considered not to have sPCa.
Number of men who avoid transperineal prostate biopsy in the experimental arm
时间窗: When the PSMA PET result is available, at most 28 days after randomisation
In the experimental arm, if PSMA PET is negative, the patient does not have biopsy
次要结局
- Anxiety as measured by the GAD7 in the diagnosis of PCa.(Within 7 days following randomisation and every 6 months ± 30 days after randomisation)
- Incidence of erectile dysfunction following transperineal prostate biopsy(Within 7 days following randomisation and at 3 and 6 months after randomisation)
- Number of men who have sPCa detected only with PSMA PET (MRI PI-RADS 2)(Within 28 days following randomisation)
- Cost per quality adjusted life year(Through study completion, estimated up to 2 years)
- Health-related quality of life as measured by the EORTC QLQ-C30.(Within 7 days of randomisation and every 6 months ± 30 days after randomisation)
- Presence of insignificant prostate cancer (isPCa) on prostate biopsy(Within 3 months following randomisation)
- Cancer worry in the diagnosis of PCa.(Within 7 days following randomisation and every 6 months ± 30 days after randomisation)
- Number of biopsy cores(Within 3 months following randomisation)
- Incidence of complications following transperineal prostate biopsy.(Within 7 days following randomisation and at 3 and 6 months after randomisation)