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

NCT01834001 | Recruiting

• 2 other identifiers: 13011913-C-0119
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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

Prostate Cancer; Prostatic Neoplasms

Keywords

Prostatic Neoplasms; Radiation; Biochemical Failure; Natural History

Outcome Measures

Primary Outcomes (1)

• To determine the rate of local recurrence in patients with prostate cancer treated with radiotherapy using multiparametric prostate MR -guided and standard biopsies.

  The primary objective is to determine the rate of local recurrence in patients with intermediate and high risk prostate cancer treated with radiotherapy that develop a rising PSA.

  completion of study

Secondary Outcomes (6)

• Post-treatment Multiparametric MR imaging

  completion of study

• MR images at failure

  completion of study

• Local failure detection

  completion of study

• clinical and radiographic predictors of local recurrence

  completion of study

• Changes in tumor tissue

  completion of study

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Men with untreated prostate cancer and men with presumed prostate cancer relapse

You may qualify if:

• 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.
• 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.

You may not qualify if:

• Patients unable to tolerate MRI (patients with pacemakers, cerebral aneurysm clips, shrapnel injuries, or other implantable electronic devices or metal not compatible with MRI).
• 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.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Deborah E Citrin, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Theresa C Cooley Zgela, R.N.

CONTACT

(301) 451-8905; theresa.cooleyzgela@nih.gov

Deborah E Citrin, M.D.

CONTACT

(240) 760-6206; citrind@mail.nih.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2013
• First Posted: April 17, 2013
• Study Start: November 13, 2013
• Primary Completion (Estimated): February 25, 2027
• Last Updated: May 7, 2026

Record last verified: 2026-04-16

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Clinical data available during the study and indefinitely. @@@@@@Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active.
• Access Criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI. @@@@@@Genomic data are made available via dbGaP through requests to the data custodians.

Locations

US (1)