Mild Hypofractionation With Proton Therapy or IMRT for Intermediate-Risk Prostate Cancer (NCT01352429) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Mild Hypofractionation With Proton Therapy or IMRT for Intermediate-Risk Prostate Cancer
United States303 participantsStarted 2009-08
Plain-language summary
This is a study to first establish feasibility of the study and then to register the treatment data of adult patients with a diagnosis of intermediate risk of prostate cancer presenting for definitive radiation treatment with either proton radiotherapy or Intensity Modulated Radiation Therapy (IMRT). The investigators propose to employ a hypofractionated strategy with our image guided treatment to further improve cancer control and decrease toxicity.
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 prostate adenocarcinoma within 365 days of registration.
* Clinical stages T1a-T2c N0 M0 (AJCC Criteria 6th Ed). For any suspicious pelvic lymph node \> 1.5cm (as exhibited on pelvic imaging), biopsy of the lymph node is suggested.
* Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material; Gleason score must be in the range 2-7. Biopsy with \> 6 cores is strongly recommended. (The highest Gleason Score in any core reported on the pathology report will be used for determining inclusion.)
* PSA values \<20 ng/ml within 90 days prior to registration, and done either prior to prostate biopsy, or at least 21 days after prostate biopsy.
* Zubrod (ECOG) status 0-1 documented within 90 days of registration.
* Androgen deprivation is at the discretion of the treating radiation oncologist.
* Subjects must give IRB-approved study-specific informed consent. Subjects must complete all required tests within the specified time frames.
* Subjects must be at least 18 years old.
* Members of all races and ethnic groups are eligible for this trial.
Exclusion Criteria
* Clinical stages T3 or greater (AJCC Criteria 6th Ed).
* PSA of 20 ng/ml or greater.
* Gleason score 8 or higher.
* Evidence of distant metastasis. (Determined by CT scan, MRI, and/or bone scan prior to the simulation appointment; imaging results from UPHS will supercede results from similar scans from an outside facility.)
* Evidence of …
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 Participants with Adverse Events
Timeframe: Within 10 days
2
Acute Toxicity
Timeframe: Within 60 days of completion of radiotherapy