Imaging Studies to Check the Local Response of Prostate Cancer to Radiation Therapy (NCT01834001) | Clinical Trial Compass
RecruitingNot Applicable
Imaging Studies to Check the Local Response of Prostate Cancer to Radiation Therapy
United States300 participantsStarted 2013-11-13
Plain-language summary
Background:
\- Radiation is a common treatment for prostate cancer. It helps damage tumor cells and causes them to die. Radiation can be effective, but some tumors may be harder to treat with radiation or even with surgery. This happens to a small number of men who have either radiation or surgery for prostate cancer. Most men who have these hard-to-treat tumors do not know if the tumor has recurred only in the prostate or has spread to another area. Also, men whose prostate cancer has recurred only after radiation may have different treatment options. This study will use improved imaging studies to better understand why some men do not respond as well to initial radiation treatments.
Objectives:
\- To use detailed imaging studies to look at the results of local radiation therapy for prostate cancer.
Eligibility:
* Men at least 18 years of age who are scheduled to have radiation for prostate cancer.
* Men at least 18 years of age whose prostate cancer has returned after earlier treatments.
Design:
* All participants will have a medical history and physical exam. Blood and urine samples will be collected. Imaging studies will be used to evaluate the cancer at the start of the study.
* All participants will have an initial full magnetic resonance imaging (MRI) scan of the prostate. Tumor and healthy tissue samples will be collected.
* Those whose cancer has recurred after treatment will discuss possible treatment options with the study doctors.
* Participants who are scheduled to have radiation will have radiation therapy. This will be given according to the current standard of treatment.
* After radiation, participants will have regular follow-up tests and imaging studies. They will have another full MRI scan 6 months after the end of radiation treatment.
Who can participate
Age range
18 Years – 120 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
. Patients must have histologically or cytologically confirmed prostate cancer. The outside pathology report is acceptable for study entry. Every effort will be made to acquire the outside pathology slides to be confirmed by the Laboratory of Pathology, NCI.
. Intermediate or high risk prostate cancer (clinical tumor stage T2b or higher, Gleason 7 or higher, or PSA greater than 10). Previously obtained MR imaging may be used for clinical T staging (extracapsular extension, seminal vesicle invasion).
. No prior local therapy (prostatectomy, radiation, cryotherapy) or hormonal therapy for prostate cancer.
. Age \>18 years.
. ECOG performance status \<2 (Karnofsky \>60%).
. Radiotherapy is planned as definitive therapy for prostate cancer. For patients not treated at NCI ROB patients must have a radiation oncologist who is willing to collaborate with the ROB and provide documentation of treatment.
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.
1This study is specifically about using multiparametric MRI-guided biopsies to check how well radiation therapy is working on prostate cancer — is this kind of detailed local monitoring something that would be useful for my specific situation, or would standard follow-up be sufficient?
2Since this trial is listed as 'Phase NA,' it seems focused on imaging and monitoring rather than testing a new treatment — can you help me understand what the actual procedures would involve, including how many MRI scans and biopsies I might need to undergo?
3The study is tracking local recurrence rates after radiotherapy — does participating mean I would receive any different radiation treatment than I would outside the trial, or would I be getting standard radiotherapy while just being more closely monitored?
4Given that this trial involves biopsies as part of the monitoring process, what are the risks associated with repeated prostate biopsies, and how does that weigh against the potential benefit of catching a local recurrence earlier?
5Are there standard post-radiotherapy monitoring approaches already available to me that we should compare against what this trial is offering, so I can make an informed decision about whether enrolling makes sense for my care?
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
To determine the rate of local recurrence in patients with prostate cancer treated with radiotherapy using multiparametric prostate MR -guided and standard biopsies.
. Ability of subject to understand and the willingness to sign a written informed consent document.
. Patients must have a history of histologically or cytologically confirmed prostate cancer. The outside pathology report is acceptable for study entry. Every effort will be made to acquire the outside pathology slides to be confirmed by the Laboratory of Pathology, NCI
Exclusion criteria
. Patients unable to tolerate MRI (patients with pacemakers, cerebral aneurysm clips, shrapnel injuries, or other implantable electronic devices or metal not compatible with MRI).
. Evidence of metastases (pelvic lymph node involvement is not an exclusion criteria). For patients with recurrent prostate cancer, oligometastatic disease (3 or fewer visible metastases) is not an exclusion criterion.
. Patients with coagulopathies who are at increased risk for bleeding or on active anticoagulation therapy (platelets less than 100,000 per mm\^3 or PT/PTT greater than 1.5 times the upper normal limit (UNL). Patients are eligible if the underlying cause is correctable.
. Subject s weight exceeding MRI or radiation treatment table tolerance.
. Patients with active urinary tract infections.
. Patients with renal insufficiency with a GFR less than 30, due to the fact that they will not be able to undergo gadolinium enhanced MRI.
. Uncontrolled illness or comorbidity that in the judgment of the PI would preclude participation in the study.