Actively Recruiting

Age: 18Years +
MALE
NCT01834001

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

Led by National Cancer Institute (NCI) · Updated on 2026-05-07

300

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Men with histologically or cytologically confirmed prostate cancer
  • Intermediate or high risk prostate cancer (clinical stage T2b or higher, Gleason score 7 or higher, or PSA greater than 10)
  • No prior local therapy (prostatectomy, radiation, cryotherapy) or hormonal therapy for prostate cancer
  • Age older than 18 years
  • ECOG performance status less than 2 (Karnofsky score greater than 60%)
  • Planned radiotherapy as definitive therapy for prostate cancer
  • Willingness and ability to sign informed consent
  • For men with presumed prostate cancer relapse: history of confirmed prostate cancer
  • Age 18 years or older
  • ECOG performance status less than or equal to 2 (Karnofsky score at least 60%)
  • Received prior definitive radiotherapy with documentation
  • Evidence of prostate cancer recurrence (biochemical relapse, palpable abnormality, or imaging evidence of local failure)
  • Willingness and ability to sign informed consent
Not Eligible

You will not qualify if you...

  • Unable to tolerate MRI due to implants or devices incompatible with MRI
  • Evidence of metastases (except pelvic lymph node involvement or up to 3 visible metastases in recurrent cancer)
  • Coagulopathy or active anticoagulation therapy with high bleeding risk (platelets less than 100,000/mm3 or prolonged PT/PTT) unless correctable
  • Weight exceeding MRI or radiation treatment table limits
  • Active urinary tract infection
  • Renal insufficiency with GFR less than 30 preventing gadolinium MRI
  • Uncontrolled illness or comorbidities preventing study participation
  • Active Hepatitis B or C infection
  • HIV-positive status due to increased radiation toxicity risk

AI-Screening

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Trial Site Locations

Total: 1 location

1

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

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Research Team

T

Theresa C Cooley Zgela, R.N.

CONTACT

D

Deborah E Citrin, M.D.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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