RecruitingNot Applicable

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

United States300 participantsStarted 2013-11-13

Plain-language 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.

Who can participate

Age range18 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

What they're measuring

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

Timeframe: completion of study

Trial details

NCT IDNCT01834001

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeOBSERVATIONAL

Primary completion2027-02-25

Contact for this trial

Theresa C Cooley Zgela, R.N.

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

View on ClinicalTrials.gov More Prostatic Neoplasms trials

Plain-language summary

Who can participate

Age range18 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

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

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Contact for this trial

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

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Contact for this trial

Exclusion criteria