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Evaluation of Local Response of Prostate Cancer to Irradiation Using Multiparametric MRI and MR-Guided Biopsies


N/A
18 Years
N/A
Open (Enrolling)
Male
Prostatic Neoplasms, Prostate Cancer

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Trial Information

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.

Inclusion Criteria


- INCLUSION CRITERIA: men with untreated prostate cancer

2.1.1.1 Patients must have histologically or cytologically confirmed prostate cancer
confirmed by the Laboratory of Pathology, NCI

2.1.1.2 Intermediate or high risk prostate cancer (clinical tumor stage T2b or higher,
Gleason 7 or higher, or PSA greater than 10). Previously obtained MR imaging may be used
for clinical T staging (extracapsular extension, seminal vesicle invasion).

2.1.1.3 No prior local therapy (prostatectomy, radiation, cryotherapy) or hormonal therapy
for prostate cancer.

2.1.1.4 Age greater than or equal to18 years.

2.1.1.5 ECOG performance status less than or equal to 2 (Karnofsky greater than or equal
to 60%).

2.1.1.6 Radiotherapy is planned as definitive therapy for prostate cancer. For patients
not treated at NCI ROB patients must have a radiation oncologist who is willing to
collaborate with the ROB and provide documentation of treatment.

2.1.1.7 Ability of subject to understand and the willingness to sign a written informed
consent document.

INCLUSION CRITERIA: for men with presumed prostate cancer relapse

2.1.2.1 Patients must have a history of histologically or cytologically confirmed prostate
cancer confirmed by the Laboratory of Pathology, NCI

2.1.2.2 Age greater than or equal to18 years.

2.1.2.3 ECOG performance status less than or equal to 2 (Karnofsky greater than or equal
to 60%, see Appendix A, Section 0).

2.1.2.4 Radiotherapy (external beam irradiation alone or in combination with hormonal
therapy and/or brachytherapy) was delivered as definitive therapy for prostate cancer and
documentation is available.

2.1.2.5 Evidence of prostate cancer recurrence (biochemical relapse by the Phoenix
definition, enlarging palpable prostatic abnormality, imaging evidence strongly suggestive
of local failure)

2.1.2.6 Ability of subject to understand and the willingness to sign a written informed
consent document.

EXCLUSION CRITERIA

2.1.3.1 Patients unable to tolerate MRI (patients with pacemakers, cerebral aneurysm
clips, shrapnel injuries, or other implantable electronic devices or metal not compatible
with MRI).

2.1.3.2 Evidence of metastases (pelvic lymph node involvement is not an exclusion
criteria)

2.1.3.3 Patients with coagulopathies who are at increased risk for bleeding or on active
anticoagulation therapy (platelets less than 100,000 per mm^3 or PT/PTT greater than 1.5
times the upper normal limit (UNL). Patients are eligible if the underlying cause is
correctable.

2.1.3.4 Subjects weighing greater than 136kg (weight limit for scanner)

2.1.3.5 Patients with active urinary tract infections

2.1.3.6 Patients with renal insufficiency with a GFR less than 30, due to the fact that
they will not be able to undergo gadolinium enhanced MRI

2.1.3.7 Uncontrolled illness or co morbidity that in the judgment of the PI would preclude
participation in the study

2.1.3.8 Hepatitis B or Hepatitis C positivity

2.1.3.9 HIV-positive patients are ineligible because HIV is known to increase radiation
toxicity and may result in under-dosing or alterations in the treatment plan that would
alter the likelihood of local recurrence. Appropriate studies will be undertaken in HIV
positive patients when indicated.

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

To determine the rate of local recurrence in patients with prostate cancer treated with radiotherapy using multiparametric prostate MR guided and standard biopsies.

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Deborah E Citrin, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

130119

NCT ID:

NCT01834001

Start Date:

April 2013

Completion Date:

February 2021

Related Keywords:

  • Prostatic Neoplasms
  • Prostate Cancer
  • MRI
  • Prostate Cancer
  • MRI-Guided Biopsy
  • Radiation
  • Biochemical Failure
  • Neoplasms
  • Prostatic Neoplasms

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892