Study on Radiation Therapy Options for Treating Stage IIA-B Prostate Cancer
Sponsor: NRG Oncology
ClinicalTrials ID:NCT03367702
This clinical trial is comparing two types of radiation therapy to see which is more effective in treating patients with Stage IIA-B prostate cancer. The study aims to determine if stereotactic body radiation therapy (SBRT) is better than intensity-modulated radiation therapy (IMRT) in reducing side effects and improving patient outcomes.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
This study is testing two different radiation treatments for Stage IIA-B prostate cancer: stereotactic body radiation therapy (SBRT) and intensity-modulated radiation therapy (IMRT). Radiation therapy uses high-energy x-rays to kill cancer cells. SBRT delivers radiation with high precision, potentially requiring fewer sessions and causing less damage to healthy tissue. The study will compare the effectiveness and side effects of these treatments to see which one works better for patients.
Description
The main goal of this study is to find out if stereotactic body radiation therapy (SBRT) is better than intensity-modulated radiation therapy (IMRT) in terms of causing fewer urinary and bowel side effects. Researchers will measure patients' quality of life related to these side effects two years after treatment. They will also compare how well each treatment prevents the cancer from coming back.
Secondary goals include checking if SBRT leads to fewer side effects related to sexual and hormonal health, and if it improves overall survival and reduces cancer spread. The study will also explore if SBRT is cost-effective compared to IMRT and if certain imaging tests can predict which patients will benefit more from each treatment.
Participants will be randomly assigned to one of two groups. One group will receive IMRT, which involves daily treatments over several weeks. The other group will receive SBRT, which involves fewer treatments over a shorter period. After treatment, patients will have regular follow-ups to monitor their health and the effectiveness of the therapy.
Eligibility Criteria
Inclusion Criteria
- Men with untreated localized prostate cancer, specifically Stage IIA-B.
- Cancer must be limited to one side of the prostate gland.
- Must meet specific criteria based on Gleason score and PSA levels.
- Prostate size must be less than 70 cc.
- Age 18 or older.
- Must have a recent physical exam and MRI of the prostate.
- Must be able to complete a quality of life questionnaire.
- Must speak English, Spanish, or French.
Exclusion Criteria
- Evidence of cancer spread beyond the prostate.
- Advanced prostate cancer (Stage T3 or higher).
- Other active cancers within the past two years, except for certain skin cancers and other specific conditions.
- Previous chemotherapy or radiation that would overlap with study treatment.
- Use of hormonal therapy is not allowed.
- Severe health conditions, such as low immune cell counts or liver problems.
- Conditions that prevent having an MRI, like certain implanted devices.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Mobile Infirmary Medical Center | 36607 | Mobile | Alabama |
| Lewis and Faye Manderson Cancer Center | 35401 | Tuscaloosa | Alabama |
| Arizona Center for Cancer Care - Gilbert | 85297 | Gilbert | Arizona |
| Arizona Center for Cancer Care-Peoria | 85381 | Peoria | Arizona |
| Arizona Center for Cancer Care - Scottsdale | 85258 | Scottsdale | Arizona |
| Arizona Center for Cancer Care-Surprise | 85374 | Surprise | Arizona |
| Arizona Oncology Associates-West Orange Grove | 85704 | Tucson | Arizona |
| University of Arkansas for Medical Sciences | 72205 | Little Rock | Arkansas |
| Kaiser Permanente-Anaheim | 92806 | Anaheim | California |
| Alta Bates Summit Medical Center-Herrick Campus | 94704 | Berkeley | California |
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