Highly Conformal, Hypofractionated, Focally Dose Escalated Post-Prostatectomy Radiotherapy

Summary

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.

Conditions

• Cancer Of Prostate
• Prostate Neoplasms
• Prostate Cancer
• Neoplasms of Prostate
• Prostatic Cancer

Interventions

RADIATION

Prostate bed with integrated boost

Radiation will be delivered at an escalated dose to areas of recurrent prostate cancer identified on imaging and a reduced dose will be delivered to the entire prostate bed.

RADIATION

Prostate bed irradiation only

Radiation will be delivered to the prostate bed only.

DIAGNOSTIC_TEST

Whole Body Bone Scan

At screening, if required by clinician.

DIAGNOSTIC_TEST

18F-NaF PET Imaging

At screening, if required by clinician.

DIAGNOSTIC_TEST

CT

Computed tomography of the abdomen and pelvis if clinically indicated at screening, with oral and intravenous contrast.

DIAGNOSTIC_TEST

mpMRI

mpMRI of the prostate bed at screening and 6 month follow up.

DRUG

ADT

After enrollment if clinically indicated (i.e., anti-androgen, gonadotropin releasing hormone agonist, or combination of both).

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Deborah E Citrin, M.D. · National Cancer Institute (NCI)

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-01-17

Primary Completion

2023-12-29

Completion

2025-12-04

FDA Device

Yes

Countries

• United States

Study Locations