Imaging Studies to Check the Local Response of Prostate Cancer to Radiation Therapy
Imaging Studies to Check the Local Response of Prostate Cancer to Radiation Therapy
Background:

 - Radiation is a common treatment for prostate cancer. It helps damage tumor cells and causes
 them to die. Radiation can be effective, but some tumors may be harder to treat with
 radiation or even with surgery. This happens to a small number of men who have either
 radiation or surgery for prostate cancer. Most men who have these hard-to-treat tumors do not
 know if the tumor has recurred only in the prostate or has spread to another area. Also, men
 whose prostate cancer has recurred only after radiation may have different treatment options.
 This study will use improved imaging studies to better understand why some men do not respond
 as well to initial radiation treatments.

 Objectives:

 - To use detailed imaging studies to look at the results of local radiation therapy for
 prostate cancer.

 Eligibility:

 -  Men at least 18 years of age who are scheduled to have radiation for prostate cancer.

 -  Men at least 18 years of age whose prostate cancer has returned after earlier
 treatments.

 Design:

 -  All participants will have a medical history and physical exam. Blood and urine samples
 will be collected. Imaging studies will be used to evaluate the cancer at the start of
 the study.

 -  All participants will have an initial full magnetic resonance imaging (MRI) scan of the
 prostate. Tumor and healthy tissue samples will be collected.

 -  Those whose cancer has recurred after treatment will discuss possible treatment options
 with the study doctors.

 -  Participants who are scheduled to have radiation will have radiation therapy. This will
 be given according to the current standard of treatment.

 -  After radiation, participants will have regular follow-up tests and imaging studies.
 They will have another full MRI scan 6 months after the end of radiation treatment.
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: men with untreated prostate cancer

 1. Patients must have histologically or cytologically confirmed prostate cancer. The
 outside pathology report is acceptable for study entry. Every effort will be made
 to acquire the outside pathology slides to be confirmed by the Laboratory of
 Pathology, NCI

 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).

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

 4. Age greater than or equal to18 years.

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

 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.

 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

 1. Patients must have a history of histologically or cytologically confirmed prostate
 cancer. The outside pathology report is acceptable for study entry. Every effort will
 be made to acquire the outside pathology slides to be confirmed by the Laboratory of
 Pathology, NCI

 2. Age greater than or equal to 18 years.

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

 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.

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

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

 EXCLUSION CRITERIA:

 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. Evidence of metastases (pelvic lymph node involvement is not an exclusion criteria).
 For patients with recurrent prostate cancer, oligometastatic disease (3 or lessfewer
 visible metastases) is not an exclusion criterion.

 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.

 4. Subjects weight exceeding MRI or radiation treatment table tolerance

 5. Patients with active urinary tract infections

 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

 7. Uncontrolled illness or comorbidity that in the judgment of the PI would preclude
 participation in the study

 8. Hepatitis B or Hepatitis C active infection

 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.