Upright MRI for Prostate Cancer Screening
Raktažodžiai
Santrauka
apibūdinimas
Prostate cancer (PCa) is the second most common cancer among men in the United States, with over 180,000 new cases diagnosed in 2016. This commonality implies that set standards need to be set and devise effective tools to screen and diagnose prostate cancer. Today, prostate specific antigen (PSA) test is the most widely adopted screening method for PCa. Since its introduction in 1979, it has helped in earlier diagnosis of PCa and has had a marked shift on the stage at which PCa is identified. PSA, although popular as a screening tool, has several shortcomings. It is organ-specific rather than cancer-specific, which means that its values can be elevated even for non-malignant conditions . Indeed, PSA based screening has reported positive predictive value as low as 30% (PSA cutoff >4.0 ng/dL) for detecting prostate cancer and an over diagnosis rate of 50%, which leads to unnecessary biopsies and aggressive treatments of men with clinically indolent (insignificant) disease.
Current diagnostic pathway of prostate cancer requires men with elevated PSA and abnormal Digital Rectal exam to undergo a Trans Rectal Ultra Sound (TRUS) guided biopsy. TRUS is a blind-systematic biopsy, which randomly samples prostate tissue. This can lead to missing or under-diagnosing clinically significant cancer and over-diagnosing clinically insignificant disease. TRUS biopsy is itself associated with morbidity, mainly in the form of hematuria, hematospermia, pain, urinary retention and sometimes can cause life-threatening sepsis.
Many of the PSA screened detected prostate cancers detected on TRUS are clinically insignificant and even if left untreated have little to no clinical impact on an individual's remaining life. Overtreatment resulting from over diagnosis often leads to side effects like erectile dysfunction (approx. 60%) from radical therapy and urinary incontinence.
Datos
| Paskutinį kartą patikrinta: | 03/31/2020 |
| Pirmasis pateikimas: | 03/15/2018 |
| Numatytas registravimas pateiktas: | 03/15/2018 |
| Pirmas paskelbtas: | 03/22/2018 |
| Paskutinis atnaujinimas pateiktas: | 04/28/2020 |
| Paskutinis atnaujinimas paskelbtas: | 04/30/2020 |
| Faktinė studijų pradžios data: | 07/31/2018 |
| Numatoma pirminio užbaigimo data: | 07/31/2024 |
| Numatoma studijų užbaigimo data: | 07/31/2024 |
Būklė ar liga
Intervencija / gydymas
Device: Upright MRI
Device: MRIs in random order
Fazė
Rankų grupės
| Ranka | Intervencija / gydymas |
|---|---|
| Standard MRI first Patients will have a standard of care MRI, then consent to study participation and have an upright MRI. | |
| MRIs in random order Patients will consent to participate in the study, then do two MRIs in random order. | Device: MRIs in random order standard of care closed 3T MRI |
Tinkamumo kriterijai
| Amžius, tinkami studijuoti | 18 Years Į 18 Years |
| Tinkamos studijoms lytys | Male |
| Mėginių ėmimo metodas | Non-Probability Sample |
| Priima sveikus savanorius | Taip |
| Kriterijai | Inclusion Criteria: - Men at risk of prostate cancer and have been advised to have a prostate MRI. - Age ≥ 18 years. - Fit for undergoing all study protocol procedures which includes an ultrasound guided biopsy. - Able to tolerate general or spinal anesthesia. - Ability to understand and the willingness to sign a written informed consent and to comply with the protocol. Exclusion Criteria: - Patients who have been treated using 5- alpha-reductase inhibitors at the time of study enrollment or 6 months prior to enrollment. - Patients with previous history of prostate biopsy, prostate surgery or treatment for prostate cancer (interventions for benign prostatic hyperplasia/bladder outflow obstruction is acceptable) - Patients who have evidence of a urinary tract infection or history of acute prostatitis within the last 3 months. - Patients contraindicated to undergoing the MRI procedure e.g. pacemaker, estimated GFR<=50, automatic implantable cardiac defibrillators. - History of any other medical condition precluding procedures described in the protocol |
Rezultatas
Pirminės rezultatų priemonės
1. PSA levels [5 years]
Antrinės rezultatų priemonės
1. Upright MRI compared to Standard MRI [5 years]
2. Claustrophobic Questionnaire (CLQ) [5 years]
3. NCCN Distress Thermometer [5 years]
4. Magnetic Resonance Imaging-Anxiety Questionnaire (MRI-AQ) [5 years]
5. Diagnostic Yield of MRI and PSA Density [5 years]
6. Number of Correctly Identified side [5 years]
