Imaging Studies to Check the Local Response of Prostate Cancer to Radiation Therapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01834001|
Recruitment Status : Recruiting
First Posted : April 17, 2013
Last Update Posted : October 22, 2020
- 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.
- To use detailed imaging studies to look at the results of local radiation therapy for prostate cancer.
- 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.
- 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.
|Condition or disease|
|Prostatic Neoplasms Prostate Cancer|
|Study Type :||Observational|
|Estimated Enrollment :||190 participants|
|Official Title:||Evaluation of Local Response of Prostate Cancer to Irradiation Using Multiparametric MRI and MR-Guided Biopsies|
|Actual Study Start Date :||November 13, 2013|
|Estimated Primary Completion Date :||February 25, 2027|
|Estimated Study Completion Date :||February 25, 2028|
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 haveexperienced biochemical failure
- 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 ]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.
- Local failure detection [ Time Frame: completion of study ]To determine if prostate MR and MR-guided biopsies enhance the ability to detect local failure after radiation compared to standard biopsy alone.
- clinical and radiographic predictors of local recurrence [ Time Frame: completion of study ]To determine the pretreatment clinical and radiographic predictors of local recurrence in intermediate and high risk prostate cancer patients treated with radiotherapy
- Biologic predictors of local recurrence [ Time Frame: Completion of study ]To define biologic predictors of local recurrence in intermediate and high risk prostate cancer patients treated with radiotherapy
- Changes in tumor tissue [ Time Frame: completion of study ]To evaluate changes in tumor tissue from post-radiotherapy recurrence compared to pretreatment biopsies with the goal of defining factors of radiation resistance
- Post-treatment Multiparametric MR imaging [ Time Frame: completion of study ]To determine if posttreatment multiparametric MR imaging correlates with treatment effect or pathologic grade on biopsy
- MR images at failure [ Time Frame: completion of study ]To compare MR images obtained at failure to whole mount prostate pathology in patients who undergo eventual salvage prostatectomy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01834001
|Contact: Theresa Cooley-Zgela, R.N.||(301) email@example.com|
|Contact: Deborah E Citrin, M.D.||(240) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937|
|Principal Investigator:||Deborah E Citrin, M.D.||National Cancer Institute (NCI)|