Study of Quality of Life for Prostate Proton Therapy
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ClinicalTrials.gov Identifier: NCT00489814 |
Recruitment Status
:
Active, not recruiting
First Posted
: June 21, 2007
Last Update Posted
: October 5, 2017
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Tracking Information | ||||
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First Submitted Date | June 19, 2007 | |||
First Posted Date | June 21, 2007 | |||
Last Update Posted Date | October 5, 2017 | |||
Actual Study Start Date | May 2006 | |||
Estimated Primary Completion Date | May 2019 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
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. [ Time Frame: 4 Years ] | |||
Original Primary Outcome Measures | Not Provided | |||
Change History | Complete list of historical versions of study NCT00489814 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures | Not Provided | |||
Original Secondary Outcome Measures | Not Provided | |||
Current Other Outcome Measures | Not Provided | |||
Original Other Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Study of Quality of Life for Prostate Proton Therapy | |||
Official Title | Prospective Evaluation of Quality of Life After Proton Therapy for Prostate Cancer | |||
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. |
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Study Type | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Probability Sample | |||
Study Population | Study participants who are planned to undergo local proton radiotherapy for biopsy-proven, untreated, prostate adenocarcinoma. | |||
Condition | Prostate Cancer | |||
Intervention | Behavioral: Questionnaire
Questionnaires administered within 3 weeks before the beginning of the radiation treatment course, twice during radiation therapy, and upon completion of radiation therapy.
Other Name: Survey |
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Study Groups/Cohorts | 1
Patients who are planned to undergo local proton radiotherapy for biopsy-proven, untreated, prostate adenocarcinoma.
Intervention: Behavioral: Questionnaire |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Active, not recruiting | |||
Estimated Enrollment |
1084 | |||
Original Estimated Enrollment |
600 | |||
Estimated Study Completion Date | May 2020 | |||
Estimated Primary Completion Date | May 2019 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | Child, Adult, Senior | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT00489814 | |||
Other Study ID Numbers | 2005-0956 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | M.D. Anderson Cancer Center | |||
Study Sponsor | M.D. Anderson Cancer Center | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | M.D. Anderson Cancer Center | |||
Verification Date | October 2017 |