Prostate Cancer Parameters for Patients Receiving Proton Treatment
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02110849|
Recruitment Status : Withdrawn (Closure of IU Health Proton Facility)
First Posted : April 10, 2014
Last Update Posted : April 7, 2016
|Condition or disease||Intervention/treatment|
|Prostate Cancer||Radiation: Proton|
The major purpose of this study is to analyze side effects experienced and self-reported by prostate cancer patients undergoing proton radiation therapy at IUHPTC. With the information collected, the investigators will establish pre-existing conditions before proton treatment and measure side effects after treatments that are not related to the pre-existing conditions. Also, to compare long-term side effects for patients who are treated with hormone suppression therapy along with their proton therapy to those patients who do not get treated with hormone suppression therapy. This information will help doctors better understand the side effects experienced and may help provide valuable information for future patients making decisions regarding their treatment options.
Finally, to develop a database of information regarding the treatment and outcomes for patients with prostate cancer in order to improve care of patients with this type of cancer.
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||0 participants|
|Observational Model:||Case Control|
|Target Follow-Up Duration:||12 Months|
|Official Title:||Longitudinal Study for the Evaluation of Safety and Efficacy Parameters in Prostate Cancer Patients Treated at IU Health Proton Therapy Center (IUHPTC)|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||April 2016|
|Estimated Study Completion Date :||April 2016|
Prostate Cancer Patients
Prostate cancer patients who received proton radiation therapy
Proton Therapy for Prostate Cancer
- To prospectively collect a composite of toxicity events on patients who treated with proton therapy for prostate cancer using the IUHPTC technique for the evaluation of toxicity and efficacy of this treatment technique. [ Time Frame: 12 months ]
A collection of toxicity events of proton therapy, evaluate the long-term side effects of hormone suppression vs. non-hormone suppression and documents the clinical benefits this therapy in regards to urinary, sexual and gastrointestinal issues.
To do this the investigators will use the following standard of care data collection forms that include; the International Index of Erectile Function (Attachment 1), the American Urological Association Symptom Index (Attachment 2) and the Radiation Therapy Initial Nursing Assessment (Attachment 3), The prostate preexisting conditions review (attachment 4) and the prostate side effects review (attachment 5). Other clinical data such us demographics, vitals, previous treatments, PSA(prostate specific antigen/Hormone results, follow up data, as described in the protocol schedule of events, will be collected as per routine standard of care.
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): NCT02110849
|United States, Indiana|
|Iu Health Proton Therapy Center|
|Bloomington, Indiana, United States, 47408|
|Principal Investigator:||Jeffery Buchsbaum, MD||Indiana University Proton Therapy Center|