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.
Additional locations may be listed on ClinicalTrials.gov for NCT03388619.
See trial information on ClinicalTrials.gov for a list of participating sites.
BACKGROUND:
Prostate cancer that recurs after prostatectomy (rising prostate-specific antigen (PSA)
with no evidence of metastatic disease is often treated with radiation to the entire
prostate bed to a dose of 66-72 Gray (Gy) over 6-7 weeks. This treatment can provide PSA
control in approximately 75% of patients but may have associated genitourinary and
gastrointestinal toxicity due to irradiation of the rectum, small bowel, and bladder.
Imaging of prostate cancer has improved to the extent that recurrent disease is often
identified in the prostate bed or in other pelvic sites. The current standard is to
irradiate the entire prostate bed to the total dose. This trial will test the
tolerability of accelerated treatment designed to yield a similar rate of late toxicity.
In addition, in patients with visible tumor, it will test the feasibility of delivering a
lower dose to the prostate bed and an integrated boost (simultaneous) to the visible
tumor to allow a higher dose to visible tumor than can be delivered with standard
approaches.
OBJECTIVE:
- Define the maximum tolerated dose (MTD) hypofractionation of image guided, focally
dose escalated post-prostatectomy radiation.
ELIGIBILITY:
- PSA recurrence after prostatectomy or indications for adjuvant radiation after
prostatectomy.
- No evidence of distant metastases of prostate cancer (pelvic lymph nodes are
allowed).
- Age greater than or equal to 18 years old
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1
DESIGN:
This is a Phase I trial of hypofractionated focal dose escalation with reduced dose
prostate bed irradiation using image and pathologic guidance. The prostate bed will be
treated with hypofractionated radiation and areas in the prostate bed or pelvis shown to
have tumor on biopsy or with advanced imaging studies will be treated with an integrated
boost to visible tumor. The treatment duration will be decreased sequentially in three
Dose Level groups. Quality of life and functional outcomes such as urine, bowel, and
erectile function will be assessed with questionnaires. A maximum of 48 patients will be
enrolled.
Lead OrganizationNational Cancer Institute
Principal InvestigatorDeborah E. Citrin
