Multiparametric MRI and Biopsy for Prostate Cancer Recurrence Detection
This study aims to determine the rate of local recurrence in patients with intermediate and high risk prostate cancer, who have been treated with radiotherapy and are experiencing a rising PSA level, using multiparametric prostate MRI-guided and standard biopsies.
Data Collection
Collected from today forward - ProspectiveUrogenital Diseases+7
+ Genital Diseases
+ Genital Diseases, Male
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: November 13, 2013
Actual date on which the first participant was enrolled.Background: Radiation therapy is a commonly used therapy for prostate cancers. The majority of men with prostate cancer will be cured by therapy; however, a subset, typically men with bulky or higher risk disease will develop PSA failure after definitive radiotherapy. Currently, men with a rising PSA after radiotherapy may receive hormonal therapy or may undergo further evaluation for local failure. It is not known how many men with rising PSA after radiotherapy may have a local failure and would benefit from a salvage local therapy. With the availability of a growing number of local salvage options, accurately defining the presence and characteristics of local failure is critical. Objective: To determine the rate of local recurrence in patients with prostate cancer treated with radiotherapy using multiparametric prostate MR guided and standard biopsies. Eligibility: Patients with no local therapy for prostate cancer: Age >= 18 years. Histologically confirmed adenocarcinoma of the prostate. Intermediate or high risk prostate cancer (clinical stage >=T2b, Gleason score 7 or higher, or PSA >10, extracapsular extension or seminal vesicle invasion on MRI). Patient will be treated with radiotherapy for prostate cancer. ECOG performance status <=2. Patients with biochemical relapse after radiotherapy for prostate cancer: Evidence of prostate cancer recurrence (palpable abnormality after radiotherapy, radiographic evidence of local failure, biochemical relapse). ECOG performance status <=2. Age >= 18 years. Histologically confirmed adenocarcinoma of the prostate. Design: Patients with untreated prostate cancer: Participants will be screened with a physical examination, medical history, laboratory tests (CBC, chemistries, liver transaminases, PSA, PT/PTT), and imaging studies (as appropriate to staging). Patients will undergo multiparametric MR imaging and MR guided prostate biopsy of all suspicious lesions (diagnostic and research). Patients will receive radiotherapy at NIH or at an outside facility. Patients will return for follow up at 3 month intervals for the first 2 years and then every six months for 5 years for PSA measurement. Patients will undergo a multiparametric MR at 6 months after therapy. No biopsy is obtained unless patients meet the definition of treatment failure. This study would allow future correlation with early changes that may predict for eventual outcome. Patients with a rising PSA that meet the criteria for biochemical failure by the Phoenix definition will undergo repeat multiparametric prostate MRI with biopsy of suspicious lesions (diagnostic and research). Patients with recurrent prostate cancer: Participants will be screened with a physical examination, medical history, laboratory tests (CBC, chemistries, Liver transaminases, PSA, PT/PTT), and imaging studies. Patients will undergo multiparametric MR imaging and MR guided prostate biopsy of all suspicious lesions (diagnostic and research). 120 patients with untreated prostate cancer and 100 patients with biochemical recurrence after radiotherapy will be accrued to this study.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.300 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Male
Biological sex of participants that are eligible to enroll.From 18 to 120 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
National Institutes of Health Clinical Center
Bethesda, United StatesOpen National Institutes of Health Clinical Center in Google Maps