RECRUITING

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

Conditions

Prostatic Neoplasms Prostate Cancer Radiation Biochemical Failure Natural History

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2013-11-13

Study Completion:N/A

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT01834001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
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 \>18 years. 5. ECOG performance status \<2 (Karnofsky \>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.	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 fewer 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. Subject s 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.

Inclusion Criteria

Exclusion Criteria

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 \>18 years.
5. ECOG performance status \<2 (Karnofsky \>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.

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 fewer 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. Subject s 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.

Contacts and Locations

Study Contact

Theresa C Cooley Zgela, R.N.

CONTACT

(301) 451-8905

theresa.cooleyzgela@nih.gov

Deborah E Citrin, M.D.

CONTACT

(240) 760-6206

citrind@mail.nih.gov

Principal Investigator

Deborah E Citrin, M.D.

PRINCIPAL_INVESTIGATOR

National Cancer Institute (NCI)

Study Locations (Sites)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892

United States

Collaborators and Investigators

Sponsor: National Cancer Institute (NCI)

Deborah E Citrin, M.D., PRINCIPAL_INVESTIGATOR, National Cancer Institute (NCI)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2013-11-13

Study Completion DateN/A

Study Record Updates

Study Start Date2013-11-13

Study Completion DateN/A

Terms related to this study

Keywords Provided by Researchers

Prostatic Neoplasms
Radiation
Biochemical Failure
Natural History

Additional Relevant MeSH Terms

Prostatic Neoplasms
Prostate Cancer