Stereotactic Body Radiation Therapy in Treating Patients With Localized High-Risk Prostate Cancer (NCT02296229) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Stereotactic Body Radiation Therapy in Treating Patients With Localized High-Risk Prostate Cancer
United States220 participantsStarted 2014-01-27
Plain-language summary
This clinical trial studies stereotactic body radiation therapy in treating patients with high-risk prostate cancer that has not spread to nearby lymph nodes or to other parts of the body. Stereotactic body radiation therapy is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue. Studying quality of life in patients undergoing stereotactic body radiation therapy may help identify the long-term effects of treatment on patients with prostate cancer.
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 primary non-metastatic adenocarcinoma of the prostate
* Risk-group classification into the D’Amico or National Comprehensive Cancer Network (NCCN) ‘high-risk’ group, as defined by the presence of any one of the following high-risk factors:
* Pre-biopsy prostate-specific antigen (PSA) \>= 20
* Biopsy Gleason score 8-10
* Clinical stage T3
* No pelvic nodal metastases (based on computed tomography \[CT\] or magnetic resonance imaging \[MRI\] findings)
* No distant metastases, based upon:
* CT scan or MRI of the pelvis within 120 days prior to registration
* Bone scan within 120 days prior to registration; if the bone scan is suspicious, a plain x-ray and/or MRI must be obtained to rule out metastasis
* Karnofsky performance status (KPS) \>= 70
* Ability to understand, and willingness to sign, the written informed consent
* Patient will have opted for SBRT among definitive treatment choices
Exclusion Criteria:
* Patients with any evidence of distant metastases
* Hormonal therapy (luteinizing hormone-releasing hormone \[LHRH\] agonist or oral anti-androgen) exceeding 4 months prior to registration
* Prior cryosurgery, high intensity focused ultrasound (HIFU) or brachytherapy of the prostate
* Prior pelvic radiotherapy
* History of Crohn’s disease or Ulcerative colitis
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
Biochemical progression free survival
Timeframe: At 3 years
2
Biochemical progression free survival
Timeframe: At 5 years
3
Incidence of patient-reported genitourinary (GU) and gastrointestinal (GI) toxicity based on the Common Terminology Criteria for Adverse Events (CTCAE) version 4
Timeframe: At 4 months
4
Incidence of patient-reported GU and GI toxicity based on the CTCAE version 4
Timeframe: Up to 5 years
5
Changes in health related quality of life based on Expanded Prostate Cancer Index Composite questionnaire