Hypofractionated Radiotherapy for Prostate Cancer

Recruiting in Palo Alto (17 mi)

Deborah E. Citrin, M.D. | Center for ...

Overseen byDeborah Citrin, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

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.

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

I am 18 years old or older.

I am mostly able to care for myself and carry out daily activities.

Ability of subject to understand and the willingness to sign a written informed consent document

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Exclusion Criteria

Subjects with any coexisting medical or psychiatric condition which, in the opinion of the Investigator likely to interfere with study procedures and/or results

I have had radiation in the same area where my prostate is.

My prostate cancer has spread outside the pelvis, but not beyond the prostate bed region.

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Treatment Details

Interventions

Dose to prostate bed irradiation only (Radiation)
Dose to prostate bed with integrated boost (Radiation)

Trial OverviewResearchers are testing shorter schedules of post-prostatectomy radiotherapy to see if they're as effective with fewer side effects. Some patients will receive standard doses while others get an increased dose focused on tumor areas identified by scans.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Arm 2/Prostate Bed Irradiation OnlyExperimental Treatment6 Interventions

Prostate bed irradiation only.

Group II: Arm 1/Prostate Bed with Integrated BoostExperimental Treatment6 Interventions

Prostate bed with integrated boost.