An observational study in Prostate Cancer, sponsored by M.D. Anderson Cancer Center. Status unknown at 1 site in United States. Open to male participants. Per ClinicalTrials.gov, last updated 2020-01-07.
Sponsored by M.D. Anderson Cancer Center · Observational
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.
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 1,125 is above the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Study participants who are planned to undergo local proton radiotherapy for biopsy-proven, untreated, prostate adenocarcinoma.
Exclusion Criteria:
Patients who are planned to undergo local proton radiotherapy for biopsy-proven, untreated, prostate adenocarcinoma.
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.
Also known as: Survey
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
This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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M.D. Anderson Cancer Center