Non-Invasive Biomarkers in Prostate Cancer Disease Management
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Disease Progression
研究概览
简要总结
This study is an observational retrospective/ prospective study with diagnosed low/intermediate risk (no-surgery) & high risk (surgery) prostate cancer that are eligible and willing to undergo standard of care (SOC) assessment, annually along with biopsies, bio-fluid collection. Participants will obtain genomic and histological evaluation on their biopsied samples. Study follows SOC collection with additional body fluid collection (blood, urine). Biopsy/surgery will not require additional sample collection
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
- 35 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Prostate cancer patients who had received primary diagnosis at Moffitt or outside the cancer center with available records (radiology, pathology, access to samples).
- •No-Surgery (Intermediate risk) group: patients diagnosed with pre-biopsy mpMRI, blood plasma: the biopsy must consist of a pathological diagnosis with a Gleason pattern score.
- •Surgery (High risk) group: patients who had radical prostatectomy (RP) with (or with-out) mpMR imaging, bio fluids available for research will be accrued for this group. We follow the NCCN recommendations for high-risk (Unfavorable intermediate risk or High-risk) groups inclusion and follow-up criteria (58, 89, 90).
- •≥ 4 ng/ml and ≤ 20 ng/ml and PSA ≤ 10 ng/ml (for late disease), within 3 months of study enrollment.
- •Age 35 through 85 years.
- •Zubrod/ECOG performance status <2;
- •Ability to understand and willingness to sign a written informed consent document.
- •Patients who agree to have a multiparametric MRI with targeted/template biopsy.
- •Patients must agree to fill out the longitudinal psychosocial questionnaires assessing health related quality of life.
- •Availability of Bio-samples (blood plasma, urine) for exosomal, proteomic, genomic and pathology (H&E slides, IHC slides).
- •Quantity of bio-samples; Blood, Urine, tissue sections (including FFPE) for each region of interest.
排除标准
- •Subject is not a candidate for multiparametric MRI with contrast. Some reasons may include (but are not limited to): renal insufficiency, foreign body or pacemakers.
- •No prior pelvic radiotherapy
- •No prior surgery to the prostate, other than transurethral procedures for benign prostatic hyperplasia (e.g., transurethral resection, green light laser treatment)
- •No concurrent, active malignancy, other than non-metastatic skin cancer of any type, superficial bladder cancer, or early-stage chronic lymphocytic leukemia (well-differentiated small cell lymphocytic lymphoma) or > Bilateral hip replacement.
研究组 & 干预措施
Intermediate risk group (no-surgery)
Participants diagnosed with pre-biopsy mpMRI.
干预措施: Genomic and Histological Evaluation (Genetic)
High-risk group (surgery)
Participants who had radical prostatectomy (RP) with (or with-out) mpMR imaging.
干预措施: Genomic and Histological Evaluation (Genetic)
结局指标
主要结局
Disease Progression
时间窗: Up to 3 years
Progression will be defined according to the National Comprehensive Cancer Network (NCCN) clinical guidelines. Intermediate risk group (no-surgery): Evaluation of targeted lesion indicates any one of the following: a) Gleason grade group of 2 or 3 (Gleason Score: 3+4 or 4+3), b) re-biopsy of lesion results in higher Gleason grade, initial GS 3+3 becomes a 3+4 or higher and c) secondary end point include clinical progression assessed by radiological progression (increased PIRADS score) and/or serum progression (PSA increase). High risk group (surgery): Participants who undergo prostatectomy as standard of care recommendation, following the NCCN guidelines. Participants in this group fall under these clinical characteristics: a) unfavorable intermediate-risk: biopsies with GS 4+3 or higher, b) high risk for prostate cancer progression: biopsies with GS 4+4 or greater or cT3 or greater disease, c) Progression following treatment, increase in PSA (
次要结局
未报告次要终点