High-Dose Stereotactic Radiation for Prostate Cancer (NCT01664130) | Clinical Trial Compass
CompletedNot Applicable
High-Dose Stereotactic Radiation for Prostate Cancer
United States35 participantsStarted 2012-07
Plain-language summary
This clinical trial studies high-dose stereotactic body radiation therapy (SBRT) in treating patients with low-, intermediate-, or high-risk localized prostate cancer. SBRT may be able to send x-rays directly to the tumor and cause less damage to normal tissue
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* The patient must have prostate adenocarcinoma proven by histologic diagnosis
* The patient must have clinical stage T1a-T3b with localized prostate cancer considered low, intermediate, or high risk as defined by the National Comprehensive Cancer Network (NCCN) guidelines; any patient whom is defined as high-risk must undergo screening with computed tomography (CT) or magnetic resonance imaging (MRI) of the abdomen and pelvis as well as bone scan prior to enrollment for staging purposes; low and intermediate risk patients do not require imaging for staging unless they have a focal symptom warranting investigation
* Performance status - Karnofsky performance status (PS) \>= 70
* Life expectancy of \> 5 years, in the opinion of and as documented by the investigator
* Patients must either already have fiducials already placed within the prostate, or otherwise be candidates for prostate fiducial placement (no bleeding disorders which may cause excessive bleeding with fiducial placement, INR \< 2.0).
* Patients must have prostate-specific antigen (PSA) drawn within the 90 days prior to enrollment
* Men must agree to use adequate contraception (double barrier method of birth control or abstinence) for the duration of study participation and for 12 months after completing treatment
* Subjects must have the ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
* Prior treatment toxicities must be resolved to …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Patients With Treatment Related GI and/or GU Toxicity as Assessed by the NCI CTCTAE Version 4.0
Timeframe: 1.5 months
2
Number of Patients With Treatment Related GI and GU Toxicity as Assessed by the NCI CTCTAE Version 4.0
Timeframe: 4 months
3
Number of Patients With Treatment Related GI and GU Toxicity as Assessed by the NCI CTCTAE Version 4.0
Timeframe: 8 months
4
Number of Patients With Treatment Related GI and GU Toxicity as Assessed by the NCI CTCTAE Version 4.0