Marker Driven Selection of Patients for Prostate Biopsy and Management: The University of Miami MDSelect Protocol
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 289
- 试验地点
- 1
- 主要终点
- Negative Predictive Value (NPV) for ruling out GG2+ prostate cancer via Habitat Risk Score (HRS) MRI Interpretation software combined with a panel of blood and urine biomarkers, versus via standard of care (SoC) MRI interpretation with PIRADS v2.
研究概览
简要总结
The purpose of this research study is to determine if the interpretation of multiparametric MRI (mpMRI) with an algorithm called habitat risk score (HRS) in combination with a panel of blood and urine biomarkers is more effective at detecting prostate cancer than standard of care interpretation of mpMRI with the Prostate Imaging Reporting and Data System (PIRADS).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male participant, aged 40-85 years.
- •In good general health as evidenced by medical history.
- •Referred for a biopsy of the prostate for evaluation of prostate cancer due to elevated or increasing prostate-specific antigen (PSA) or an abnormal digital rectal exam (DRE).
- •Participant must agree to forego testosterone supplementation during the duration of the study due to unknown impacts on prostate cancer biomarkers.
排除标准
- •Previous or current history of prostate cancer or treatment for prostate cancer.
- •Previous history of pelvic radiation.
- •Known allergic reactions to MRI contrast or inability to undergo MRI due to renal toxicity.
- •Inability to undergo blood draw or biopsy of the prostate as per protocol.
- •Prior MRI guided biopsy of the prostate for prostate cancer evaluation.
- •Previous prostate biopsy or prostate procedure within 6 months of enrollment within the trial.
- •Standard contraindications to MRI, such as allergies to contrast die, renal toxicity, ferromagnetic metal in body/eye, pacemaker, defibrillator, other mechanical device, or extreme claustrophobia (medication with anti-anxiety agents, such as Ativan, may be attempted) will prevent eligibility and will be applied for all protocol-related MRIs.
- •Patients with impaired decision-making capacity.
研究组 & 干预措施
GG2+ Prostate Cancer Risk
Participants at risk for Grade Group 2 (GG2+) prostate cancer. Participants will be followed for up to two years to rule out the presence of GG2+ prostate cancer
结局指标
主要结局
Negative Predictive Value (NPV) for ruling out GG2+ prostate cancer via Habitat Risk Score (HRS) MRI Interpretation software combined with a panel of blood and urine biomarkers, versus via standard of care (SoC) MRI interpretation with PIRADS v2.
时间窗: Up to 24 months
The investigators will assess whether automated quantitative HRS MRI interpretation software combined with a panel of blood and urine biomarkers incrementally improves the negative predictive value for ruling out GG2+ cancer on prostate biopsy by 30% or more above standard of care (SoC) MRI interpretation with PIRADS v2.
次要结局
- NPV for ruling out GG2+ prostate cancer via HRS MRI Interpretation software versus via SoC MRI interpretation with PIRADS v2(Up to 24 months)
- NPV for ruling out GG2+ prostate cancer by a panel of blood and urine biomarkers versus via SoC MRI interpretation with PIRADS v2(Up to 24 months)
- NPV for ruling out clinically significant prostate cancer via HRS MRI interpretation software combined with a panel of blood and urine biomarkers versus via SoC MRI interpretation with PIRADS v2(Up to 24 months)
研究者
Sanoj Punnen, MD, MAS
Associate Professor
University of Miami