RecruitingPhase not listed

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 120 Years
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 5 years
  • Procedures mentioned: Physical exams, Urine samples, MRI scans, Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "They will have another full MRI scan 6 months after the end of radiation treatment."
  • "Objective: To determine the rate of local recurrence in patients with prostate cancer treated with radiotherapy using multiparametric prostate MR guided and standard biopsies."
  • "Intermediate or high risk prostate cancer (clinical stage \>=T2b, Gleason score 7 or higher, or PSA \>10, extracapsular extension or seminal vesicle invasion on MRI)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study uses detailed scans to see how prostate cancer responds to radiation treatment. It is for men who plan to have radiation or whose cancer may have returned after radiation.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have prostate cancer confirmed by a tissue or cell test.
  • For untreated cancer: be older than 18. For cancer that may have returned: be 18 or older.
  • For untreated cancer: have cancer with a medium or high risk of getting worse.
  • For untreated cancer: have had no prostate cancer surgery, radiation, freezing treatment, or hormone treatment.
  • For untreated cancer: plan to have radiation as the main treatment. If treated outside the study center, your radiation doctor must work with the study team and share treatment records.
  • For cancer that may have returned: have records of earlier radiation as the main treatment, plus blood tests, an exam, or scans that suggest the cancer has returned.
  • Be able to do most daily activities. Men whose cancer may have returned can need more help than men with untreated cancer.
  • Be able to understand the study and sign a form agreeing to take part.

Who can't join

  • Cannot safely have an MRI scan, such as because of certain metal implants or electronic devices.
  • Have cancer that has spread. Spread to lymph nodes in the pelvis is allowed. For cancer that has returned, up to 3 visible areas of spread are allowed.
  • Have a blood-clotting problem that raises bleeding risk, or take blood thinners. You may qualify if the cause can be corrected.
  • Weigh more than the MRI or radiation treatment table can safely hold.
  • Have an active infection in the urinary tract, which includes the bladder and kidneys.
  • Have very poor kidney function, with a GFR below 30, which prevents use of the dye needed for the MRI.
  • Have an uncontrolled illness or another health problem that the lead study doctor believes makes participation unsafe.
  • Have active hepatitis B or C infection, or have HIV.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 \>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. 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.

Study sites (1)

MD