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

Launched by NATIONAL CANCER INSTITUTE (NCI) · Apr 13, 2013

Keywords

ClinConnect Summary

This clinical trial is investigating how well radiation therapy works for treating prostate cancer and aims to understand why some tumors do not respond as effectively to this treatment. By using advanced imaging techniques, researchers hope to determine if the cancer has returned only in the prostate or if it has spread to other areas. This information could help doctors offer better treatment options for men whose prostate cancer has come back after previous therapies.

To participate in this study, men must be at least 18 years old and either scheduled for radiation therapy for prostate cancer or have had their cancer return after earlier treatments. Participants will undergo a series of tests, including medical exams and imaging scans, and will receive standard radiation treatment if eligible. They will also have follow-up tests to monitor their progress. It's important for potential participants to know that this study will help improve understanding and treatment of prostate cancer, especially for those facing challenges with their current therapies.

Gender

MALE

Eligibility criteria

• • 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 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.