Recruiting

Imaging Studies

Sponsor:

National Cancer Institute (NCI)

Code:

NCT01834001

Conditions

Prostatic Neoplasms

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

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 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

Prostatic Neoplasms

Prostate Cancer

Study ID

NCT01834001

Start date

Nov 13, 2013

Status verified date

Aug 14, 2026

Primary completion date

Feb 25, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

  • 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 Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

1/Untreated prostate cancer

Patients with untreated prostate cancer

2/Radiotherapy treated prostate cancer

Patients with prostate cancer who have already received definitive radiotherapy and have experienced biochemical failure

Primary outcome measure

  • To determine the rate of local recurrence in patients with prostate cancer treated with radiotherapy using multiparametric prostate MR -guided and standard biopsies. [ Time Frame: completion of study ]

Central Contacts and Locations

Central contacts

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

More Information

Sponsor

National Cancer Institute (NCI)

Last update posted

Sep 1, 2026

Last verified

Aug 14, 2026

Keywords

  • Prostatic Neoplasms
  • Radiation
  • Biochemical Failure
  • Natural History

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Cancer Institute (NCI) on 2026-09-01.