CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 30 enrolled
Drug / intervention
ADT +6 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03388619
NCT03388619Phase 1Completed

A Phase I Trial of Highly Conformal, Hypofractionated, Focally Dose Escalated Post-Prostatectomy Radiotherapy

National Cancer Institute (NCI)·interventional·Posted Jan 3, 2018·Updated May 27, 2026

In Brief

A Phase 1 clinical trial evaluating Prostate bed with integrated boost, Prostate bed irradiation only, and 5 other interventions for Cancer Of Prostate and 4 related conditions. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedJan 3, 2018
Enrollment StartJan 17, 2018
Primary CompletionDec 29, 2023
Study CompletionDec 4, 2025
TodayJul 2, 2026
Enrollment to primary: 6.0 yearsPosted 8.5 years ago

Interventions

Prostate bed with integrated boostradiation

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.

Prostate bed irradiation onlyradiation

Radiation will be delivered to the prostate bed only.

Whole Body Bone Scanother

At screening, if required by clinician.

18F-NaF PET Imagingother

At screening, if required by clinician.

CTother

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

mpMRIother

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

ADTdrug

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