Hypofractionated Proton Beam Therapy for Localized Prostate Cancer (NCT01950351) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Hypofractionated Proton Beam Therapy for Localized Prostate Cancer
United States241 participantsStarted 2013-10-10
Plain-language summary
This phase II trial studies the side effects and how well hypofractionated proton beam radiation therapy works in treating patients with prostate cancer that has not spread to nearby lymph nodes or to other parts of the body. Specialized radiation therapy, such as proton beam radiation therapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells 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:
* Histologically confirmed diagnosis of adenocarcinoma of the prostate within one year of study entry; evaluation can happen outside of MD Anderson as long as histological confirmation takes place at MD Anderson
* History/physical examination with digital rectal examination of the prostate within 90 days prior to registration
* Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material demonstrating Gleason score 2-7 within 365 days of registration
* Clinical stage T1-2b (American Joint Committee on Cancer \[AJCC\] 7th edition) and PSA \< 20 ng/mL within 90 days prior to registration; PSA should not be obtained within 10 days after prostate biopsy
* Zubrod performance status 0-1 within 90 days prior to registration
* Patient must be able to provide study-specific informed consent prior to study entry
* Willingness and ability to complete the EPIC questionnaire
Exclusion Criteria:
* Prior or concurrent invasive malignancy (except non-melanomatous skin cancer or lymphomatous/hematogenous malignancy) unless continually disease free for a minimum of 5 years
* Evidence of distant metastases
* Regional lymph node involvement
* Previous prostatectomy, cryosurgery, or high intensity focused ultrasound (HIFU) for prostate cancer
* Previous pelvic radiation or prostate brachytherapy
* Active and severe medical co-morbidity defined as follows: unstable angina and/or congestive heart failure requiring hospitalization within…
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
Cumulative incidence of late grade 2 or greater gastrointestinal (GI) toxicity