Multi-cohort Investigational Study to Evaluate the Impact of Pelvic Mp-3TMRI and Whole-body 68Ga-PSMA PET/CT for Diagnosis of Clinically-significant Prostate Cancer and Pre-surgical Staging.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 261
- 试验地点
- 4
- 主要终点
- Positive predictive value of both 68Ga-PSMA PET/CT and mp-3TMRI imaging
研究概览
简要总结
BIOPSTAGE is a prospective, non-randomized, diagnostic, multi-cohort investigational study to evaluate the impact of pelvic Multi-parametric 3-Tesla magnetic resonance imaging (mp-3TMRI) and whole-body 68Ga-PSMA PET/CT for diagnosis of clinically-significant prostate cancer and pre-surgical staging.
详细描述
The aim of this study is to characterize the diagnostic accuracy of both multi-parametric pelvic Magnetic Resonance Imaging (MRI) (T2-weighted, Diffusion Weighted Imaging (DWI), Dynamic Contrast Enhancement (DCE) and 68Ga-chelated Prostate Specific Membrane Antigen ligand (68Ga-PSMA) Positron Emission Tomography/Computed Tomography (PET /CT) in three cohorts of patients:
- COHORT 1 Guiding prostate biopsies in men with clinical suspicion and/or unconfirmed clinically-significant prostate cancer (CS-PCa) on initial prostate biopsy;
- COHORT 2 Targeting repeat prostate biopsy in patients on Active Surveillance (PRIAS Study), scheduled for PRIAS repeat biopsy;
- COHORT 3
Providing pelvic / whole-body pre-surgical staging in:
- 3a: men with high-risk PCa (HR-PCa);
- 3b: men candidates for nerve sparing surgery (NSS);
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Cohort 1 - Biopsy guidance in clinically-suspected PCa
- •Men aged 45 to 75 years old with clinically-suspected PCa candidated for either initial or repeat TRUS-guided prostate biopsy, meeting any of the following criteria:
- •a) Abnormal PSA metrics, defined as follows:
- •A rising and/or persistently elevated serum PSA (i.e PSA > 2.5ng/ml for men in the age group comprising 60 to 75 years old; PSA > 3.0ng/ml for men in the age group comprising 45 to 60 years old) and at least one of the following PSA-based metrics:
- •i. Percent free PSA (%fPSA) < 25% with PSA range 4-10ng/ml (NCCN); ii. PSA velocity (PSAvel) >0.35 ng/mL/y; iii. PSA density (PSAden) > 0.25ng/mL/cc iv. PSA > 10ng/ml, 50% risk of PCa (EAU) b) Suspicious digital rectal examination (DRE), 5-30% risk of PCa; c) Prostate Cancer Gene 3 (PCA3) > 35; d) Suspicious findings on first-round biopsy: i. A few Atypical Glands immediately adjacent to HG-PIN, 50% risk of PCa; ii. Atypical Small Acinar Proliferation, 40% of PCa; iii. Multifocal High-Grade Prostatic intraepithelial neoplasia (HG-PIN), 30% ; iv. Intraductal carcinoma as solitary finding, 90% of PCa;
- •Cohort 2 - Biopsy guidance on Active Surveillance
- •Men consenting to enter the PRIAS MRI side-study as per currently inclusion criteria in Version Number 1.0 dated August 20,
- •Histologically-proven adenocarcinoma of the prostate;
- •Men should be fit for curative treatment;
- •Clinical stage T1c or T2;
- •Gleason score 3+3=6;
- •One or two biopsy cores invaded with prostate cancer:
- •If an MRI, including targeted biopsies on positive lesions, is done at inclusion, there is no limit in the number of positive cores (that is, more than two, and no limit in the % of cancer present in the cores);
- •If saturation biopsies (either trans-perineal or trans-rectal) are done 15% of the cores can be positive with a maximum of 4 (i.e. 26 cores 4 cores can be positive) (all other inclusion criteria still apply);
- •PSA density (PSA D) less than 0.2;
- •PSA-level at diagnosis ≤ 10 ng/mL;
- •Cohort 3a - Pre-surgical TNM staging in high-risk prostate cancer
- •Male, aged 18 years or older;
- •Cyto / histological confirmation of PCa (i.e. TRUS-guided biopsies; TURP);
- •Any of the PCa high risk features for Organ-Confined Disease (OCD):
- •Clinical T stage ≥ T2c;
- •Gleason Score ≥ 8;
- •Serum PSA > 20 ng/mL;
- •Any of the PCa high-risk features for Locally-Advanced Disease (LAD):
- •Clinical T stage ≥ T3b-T4 OR any T and clinical N1 disease;
- •Gleason Score ≥ 8;
- •Serum PSA > 20 ng/mL;
- •Routine clinical staging (CTscan ± Bone scan) performed within 12 weeks enrolment returning negative or equivocal results for distant metastatic disease;
- •Cohort 3b - pelvic TNM staging of prostate cancer prior to nerve-sparing radical prostatectomy
- •Male, aged 18 years or older;
- •Cyto / histological confirmation of PCa (i.e. TRUS-guided biopsies; TURP);
- •All of the following PCa-related features must be met for nerve-sparing (either mono- or bi-lateral):
- •Clinical T stage ≤ T2b;
- •Gleason Score ≤ 7 (3+4) and maximum one biopsy with Gleason > 6 at the ipsilateral side;
- •Serum PSA < 10 ng/mL;
排除标准
- •The participant may not enter the study if ANY of the following apply:
- •Hormone androgen deprivation therapy of any type within 6 months prior to enrollment.
- •Prior pelvic radiotherapy;
- •Sickle cell disease;
- •Insufficient renal function (eGFR < 30 mL/min/1.73 m2);
- •Hip prosthesis, vascular grafting or other conditions affecting imaging;
- •Contraindication to MRI, including but not restricted to: pacemaker or other electronic im-plants, known metal in the orbit, MR incompatible surgical or cerebral aneurysm clips, shrapnel, tattoos, non-removable body piercings (relative contraindications);
- •History of allergic reactions attributed to compounds of similar chemical or biologic com-position to 68Ga-PSMA or Gadolinium-based contrast agents used in the study.
结局指标
主要结局
Positive predictive value of both 68Ga-PSMA PET/CT and mp-3TMRI imaging
时间窗: up to 36 months
Positive predictive value will be calculated considering the ratio between positive patient at 68Ga-PSMA PET/CT/mp-3TMRI confirmed as positive throughout biopsy and overall positive patient at 68Ga-PSMA PET/CT/mp-3TMRI
specificity of both 68Ga-PSMA PET/CT and mp-3TMRI imaging
时间窗: up to 36 months
specificity will be calculated considering negative cases at 68Ga-PSMA PET/CT or mp-3TMRI and number of patients who underwent to these exams
sensitivity of both 68Ga-PSMA PET/CT and mp-3TMRI imaging
时间窗: up to 36 months
sensitivity of both 68Ga-PSMA PET/CT and mp-3TMRI imaging will be calculated as the ratio between the number of positive cases at 68Ga-PSMA PET/CT or mp-3TMRI and number of patients who underwent to these exams
negative predictive value of both 68Ga-PSMA PET/CT and mp-3TMRI imaging
时间窗: up to 36 months
negative predictive value will be calculated considering the ratio between negative patient at 68Ga-PSMA PET/CT/mp-3TMRI confirmed as negative throughout biopsy and overall negative patient at 68Ga-PSMA PET/CT/mp-3TMRI
次要结局
- Incidence of adverse events(up to 30 days following study procedures)