Evaluation of Local Response of Prostate Cancer to Irradiation Using Multiparametric MRI and MR-Guided Biopsies
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 greater than or equal to 18 years
Histologically confirmed adenocarcinoma of the prostate
Intermediate or high risk prostate cancer (clinical stage greater than or equal to T2b,
Gleason score 7 or higher, or PSA greater than10, extracapsular extension or seminal vesicle
invasion on MRI).
Patient will be treated with radiotherapy for prostate cancer.
ECOG performance status less than or equal to 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 less than or equal to 2
Age greater than or equal to 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
70 patients with biochemical recurrence after radiotherapy will be accrued to this study.
Observational
Time Perspective: Prospective
To determine the rate of local recurrence in patients with prostate cancer treated with radiotherapy using multiparametric prostate MR guided and standard biopsies.
5 years
No
Deborah E Citrin, M.D.
Principal Investigator
National Cancer Institute (NCI)
United States: Federal Government
130119
NCT01834001
April 2013
February 2021
Name | Location |
---|---|
National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda, Maryland 20892 |