PSMA-Guided Ablation of the Prostate: A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 138
- 试验地点
- 6
- 主要终点
- Tumor Staging- Detection of any clinically significant prostate cancer
研究概览
简要总结
The goal of this phase 2 multicenter randomized controlled trial is to study the accuracy of second generation prostate specific membrane antigen (PSMA) positron emission tomography (PET; utilizing 18F-PSMA-1007) compared to standard of care multiparametric MRI and MRI targeted-prostate biopsy for staging in patients diagnosed with unilateral prostate cancer who are eligible for focal therapy.
The main question it aims to answer is:
Can PSMA PET improve diagnostic accuracy for the primary staging of Prostate Cancer for patients undergoing focal therapy thereby reducing residual and recurrence disease?
Participants who are eligible by current standard of care diagnostic workup will undergo 1:1 randomization to PSMA PET scan or no further imaging. Those diagnosed with bilateral disease by PSMA PET will be ineligible for focal therapy and be referred for radical therapy. Men with unilateral disease on PSMA PET and those randomized to no further imaging will then undergo focal therapy. All men undergoing focal therapy will receive PSMA PET, MRI, and combined targeted and systematic biopsy 12 months after ablation. The primary outcome will be the detection of Gleason Grade Group 2 or higher prostate cancer in men 12 months after hemigland ablation.
详细描述
- Background & Rationale
Focal therapy is emerging as a new treatment strategy for appropriately selected men with localized prostate cancer. Focal therapy (also called partial gland ablation) is the concept of treating only where the tumor is believed to be located within the prostate, leaving normal healthy regions of the prostate untreated. Thus, focal therapy minimizes treatment side effects such as erectile dysfunction and incontinence, while providing good cancer control.
The foundation of performing oncologically sound partial gland ablation is possessing a high degree of diagnostic certainty that the tumor is limited to the region that is being treated and is not unknowingly present elsewhere in the gland. However, this is currently a major diagnostic challenge. The current diagnostic strategy for work-up of a patient for focal therapy is based on a pre-operative multiparametric MRI and combined targeted and systematic prostate biopsy showing intermediate risk prostate cancer localized to only one side of the prostate gland. This combination has been shown to accurately diagnose the final tumor grade in 96.5% of men. However, whole mount pathology data after radical prostatectomy shows that over 50% of cases that would pre-operatively have been deemed appropriate for focal therapy, which is a unilateral treatment, in fact harbour bilateral disease, which would mean that contralateral tumor would be inadvertently left untreated. Similarly, our group has shown that of the 35% of men who were found to have residual tumor after hemigland ablation of their prostate for unilateral disease, two-thirds of residual tumors were identified on the side contralateral to the ablative treatment. Therefore, our current gold standard pre-operative imaging and biopsy techniques are under staging many men who are undergoing focal therapy and a new paradigm is required to advance focal ablative treatments.
PSMA PET is a new imaging technique that uses a radioligand that binds to prostate specific membrane antigen (PSMA). PSMA is expressed at high levels in prostate cancer and the degree of expression correlates proportionately with tumor grade. A second generation PSMA PET radioligand, called 18F-PSMA-1007, has been used extensively at our site and possesses the key attributes of minimal urinary excretion, high resolution, and a half-life that as Gallium based radioligands. This makes 18F-PSMA-1007 an excellent candidate for improving the intraprostatic diagnostic accuracy of prostate cancer localization in patients considering focal therapy as a treatment option. 2. Research Question & Objectives
Primary outcome:
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Clinical stage < T2b
- •Combined targeted and systematic MRI-guided biopsy shows unilateral Gleason Grade Group 2 or 3 prostate cancer
排除标准
- •Unable to obtain consent
- •Weight >250 kg (weight limitation of scanners)
- •Unable to lie flat for 30 minutes to complete the PET imaging
- •Lack of intravenous access
- •eGFR < 40 mL/min/1.73 m2 and/or a history of a severe reaction to CT contrast
- •Prior androgen deprivation therapy or radiation therapy to prostate gland
研究组 & 干预措施
PSMA PET
These patients will have been diagnosed with unilateral prostate cancer by standard of care diagnostic tests deemed eligible and interested in focal therapy. These patients will be randomized to undergo a single [18]F-PSMA-1007 PET/CT or PET/MRI scan prior to focal therapy. If they are diagnosed with bilateral disease, they will be ineligible for focal therapy and be referred for radical therapy. Those with unilateral disease will then proceed to focal therapy. They will then receive PSMA PET, MRI, and combined targeted and systematic biopsy 12 months after ablation
Intravenous bolus injection of 4 MBq/kg +/- 10% of [18]F-PSMA-1007, up to a maximum of 400 MBq.
干预措施: PSMA-1007 Positron Emission Tomography (PET) scan (Diagnostic Test)
No Additional Imaging
These patients will have been diagnosed with unilateral prostate cancer by standard of care diagnostic tests deemed eligible and interested in focal therapy. These patients will undergo no further testing and will undergo focal therapy.
They will then receive PSMA PET, MRI, and combined targeted and systematic biopsy 12 months after ablation.
Intravenous bolus injection of 4 MBq/kg +/- 10% of [18]F-PSMA-1007, up to a maximum of 400 MBq.
结局指标
主要结局
Tumor Staging- Detection of any clinically significant prostate cancer
时间窗: 12 months after hemigland ablation.
Detection of any clinically significant prostate cancer (defined as greater than or equal to Gleason Grade Group 2) at MRI-guided combined targeted and systematic biopsy
次要结局
- Tumor Staging - bilateral disease on PSMA PET prior to hemi-gland ablation(Prior to hemigland ablation - at study enrollment)
- Tumor Staging - bilateral disease on PSMA PET after hemi-gland ablation(12 months after hemigland ablation.)
- Tumor Staging- rate of contralateral Gleason Grade Group 2 or greater prostate cancer at biopsy(12 months after hemigland ablation.)
- Side Effects of Intervention(Immediately after the imaging)
- Early Economic analysis(12 months after hemigland ablation)
- Quality of Life Outcomes - EPIC-26(Through Study Completion, completion by end of study at 5 year mark. Every 3 months for first year and every 6months-1 year after)
- Quality of Life Outcomes - IIEF 5(Through Study Completion, completion by end of study at 5 year mark. Every 3 months for first year and every 6months-1 year after)
- Tumor Staging - rate of contralateral Gleason Grade Group 2 or greater prostate cancer at final pathology(Through study completion, expected within 1 year of randomization)
- Quality of Life Outcomes - EQ-5D-5L(Through Study Completion, completion by end of study at 5 year mark. Every 3 months for first year and every 6months-1 year after)
- Tumor Staging - 5-year failure free survival(5 years after hemigland ablation)
- Quality of Life Outcomes - AUA Symptom Score(Through Study Completion, completion by end of study at 5 year mark. Every 3 months for first year and every 6months-1 year after)
- Post Trial Economic analysis(Through Study Completion, completion by end of study at 5 year mark)