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

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

January 17, 2018

Primary Completion Date

December 29, 2023

Study Completion Date

December 8, 2025

Conditions
Cancer Of ProstateProstate NeoplasmsProstate CancerNeoplasms of ProstateProstatic 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).

Trial Locations (1)

20892

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH