Status:
RECRUITING
Imaging Studies to Check the Local Response of Prostate Cancer to Radiation Therapy
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Prostatic Neoplasms
Prostate Cancer
Eligibility:
MALE
18+ years
Brief Summary
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 radiati...
Detailed Description
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...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA: men with untreated prostate cancer.
- 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.
- 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).
- No prior local therapy (prostatectomy, radiation, cryotherapy) or hormonal therapy for prostate cancer.
- Age \>18 years.
- ECOG performance status \<2 (Karnofsky \>60%).
- 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.
- Ability of subject to understand and the willingness to sign a written informed consent document.
- INCLUSION CRITERIA: for men with presumed prostate cancer relapse
- 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
- Age greater than or equal to 18 years.
- ECOG performance status less than or equal to 2 (Karnofsky greater than or equal to 60%).
- 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.
- Evidence of prostate cancer recurrence (biochemical relapse by the Phoenix definition, enlarging palpable prostatic abnormality, imaging evidence strongly suggestive of local failure)
- Ability of subject to understand and the willingness to sign a written informed consent document.
- EXCLUSION CRITERIA:
- Patients unable to tolerate MRI (patients with pacemakers, cerebral aneurysm clips, shrapnel injuries, or other implantable electronic devices or metal not compatible with MRI).
- 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.
- 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.
- Subject s weight exceeding MRI or radiation treatment table tolerance.
- Patients with active urinary tract infections.
- 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.
- Uncontrolled illness or comorbidity that in the judgment of the PI would preclude participation in the study.
- Hepatitis B or Hepatitis C active infection.
- 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.
Exclusion
Key Trial Info
Start Date :
November 13 2013
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT01834001
Start Date
November 13 2013
Last Update
January 9 2026
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892