Hypofractionated Radiotherapy for Prostate Cancer
Trial Summary
What is the purpose of this trial?
Background: Sometimes prostate cancer comes back after a person's prostate is removed. In this case, radiation is a common treatment. Radiation kills prostate cancer cells. It can be very effective. It is usually given in short doses almost every day for 6 or 7 weeks. Researchers want to see if a shorter schedule can be as effective. They want to see if that causes the same or fewer side effects. Usually, radiation is used to treat the entire area where the prostate was before surgery. In some patients, an area of tumor can be seen on scans. Researchers are also trying to see if they can give less dose to the area usually treated with radiation if the full dose is given to the tumor seen on scans. Objective: To find the shortest radiation schedule that people can tolerate without strong side effects. Eligibility: People at least 18 years old who have had a prostatectomy and will get radiation. Design: Participants will be screened with: * Medical history * Physical exam * Blood and urine tests * Scan that uses a small amount of radiation to make a picture of the body * Scan that uses a magnetic field to make an image of the body * Participants will provide documents that confirm their diagnosis. * Participants may have a scan of the abdomen and pelvis. Before they start treatment, participants will have another physical exam and blood tests. Participants will get radiation each day Monday through Friday. Treatment may last 2, 3, or 4 weeks. Participants may provide a tissue sample from a previous procedure for research. Participants will answer questions about their general well-being and function. About 4-5 weeks after they finish radiation treatment, participants will have a follow-up visit. They will be examined and give a blood sample. They will have 6 follow-up visits for the next 2 years.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you are taking investigational drugs or radiosensitizing drugs (medications that make cancer cells more sensitive to radiation).
What data supports the effectiveness of the treatment Hypofractionated Radiotherapy for Prostate Cancer?
Research shows that using hypofractionated radiotherapy (a treatment where higher doses of radiation are given in fewer sessions) with a simultaneous integrated boost (targeting the tumor more precisely) can effectively control prostate cancer while maintaining quality of life. Studies indicate that this approach can reduce the risk of cancer returning and manage side effects better than traditional methods.12345
Is hypofractionated radiotherapy for prostate cancer safe?
Research shows that hypofractionated radiotherapy, which involves giving higher doses of radiation over fewer sessions, is generally safe for treating prostate cancer. Studies have evaluated its safety, focusing on both short-term and long-term side effects, and found it to be tolerable for patients.23567
How is hypofractionated radiotherapy with integrated boost different from other prostate cancer treatments?
Hypofractionated radiotherapy with integrated boost for prostate cancer is unique because it delivers larger doses of radiation in fewer sessions, potentially increasing the effectiveness of the treatment without increasing side effects. This approach targets the prostate more precisely, allowing for a higher dose to the cancerous area while sparing surrounding healthy tissue.158910
Research Team
Deborah Citrin, MD
Principal Investigator
National Cancer Institute (NCI)
Eligibility Criteria
Men over 18 who've had their prostate removed and need radiation can join. They must use birth control, have a stable health status (ECOG ≤1), and no history of severe immune deficiency or opportunistic infections if HIV+. No current participation in other trials, prior pelvic radiation, inflammatory bowel disease, lupus, scleroderma, genetic hypersensitivity to radiation or metastases outside the pelvis are allowed.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive hypofractionated radiation treatment to the prostate bed, with an integrated boost to visible tumors, Monday through Friday for 2, 3, or 4 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment, with follow-up visits including examinations and blood tests
Treatment Details
Interventions
- Dose to prostate bed irradiation only
- Dose to prostate bed with integrated boost
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor