Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00489814
Status:
UNKNOWN
Last Update Posted:
2020-01-07
First Post:
2007-06-19
Brief Title:
Study of Quality of Life for Prostate Proton Therapy
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Prospective Evaluation of Quality of Life After Proton Therapy for Prostate Cancer
Status:
UNKNOWN
Status Verified Date:
2020-01
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this research study is to collect information on the side effects of proton radiation therapy given for the treatment of prostate cancer as well as the effect of proton therapy on quality of life Information on your treatment and how you react to the treatment will be collected Researchers will use this information to try to understand how people tolerate proton radiation therapy for prostate cancer
Detailed Description:
Prostate cancer tends to be better controlled with higher doses of radiation These high doses may lead to more side effects Standard radiation therapy uses x-rays which are effective but may cause extra radiation dose to be given to tissues beyond the tumor such as the rectum and bladder Unlike x-rays protons small positively-charged particles can deliver radiation dose to a specific target but then suddenly deliver much less dose beyond the target This minimizes the dose to normal tissues and may lead to fewer side effects even when high doses are delivered to the tumor
If you agree to take part in this study it will involve completing quality of life questionnaires before during and after proton therapy You will be asked how you tolerated the proton therapy what if any side effects you experienced and how the treatment impacts the quality of your life The questionnaires should each take about 15 minutes to complete They may be done in person by mail or by phone
You will complete the questionnaires before the proton therapy begins and during the last week of therapy You will also repeat the questionnaires at 3 6 9 and 12 months after the proton therapy every 6 months for the next 3 years and every year for the next 6 years after that If you are receiving hormone therapy you will also be asked to fill out a questionnaire before or at the beginning of hormone therapy During your radiation course you will have a brief weekly clinic visit and assessed for any side effects during that visit as part of normal standard practice Your information will be compiled with the information from other people who were treated similarly to better understand the effects of prostate proton radiation therapy
Throughout the course of your radiation therapy you will have brief clinic visits once a week as part of your standard care You will be checked for any side effects
Your participation in the study will be over after you mail back the last questionnaire
This is an investigational study Up to 1084 patients will take part in this study All will be enrolled at M D Anderson
If you agree to take part in this study it will involve completing quality of life questionnaires before during and after proton therapy You will be asked how you tolerated the proton therapy what if any side effects you experienced and how the treatment impacts the quality of your life The questionnaires should each take about 15 minutes to complete They may be done in person by mail or by phone
You will complete the questionnaires before the proton therapy begins and during the last week of therapy You will also repeat the questionnaires at 3 6 9 and 12 months after the proton therapy every 6 months for the next 3 years and every year for the next 6 years after that If you are receiving hormone therapy you will also be asked to fill out a questionnaire before or at the beginning of hormone therapy During your radiation course you will have a brief weekly clinic visit and assessed for any side effects during that visit as part of normal standard practice Your information will be compiled with the information from other people who were treated similarly to better understand the effects of prostate proton radiation therapy
Throughout the course of your radiation therapy you will have brief clinic visits once a week as part of your standard care You will be checked for any side effects
Your participation in the study will be over after you mail back the last questionnaire
This is an investigational study Up to 1084 patients will take part in this study All will be enrolled at M D Anderson
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None