Daily Adaptive Post-Prostatectomy With Stereotactic Ablative Radiotherapy in Patients With Prostate Cancer

Summary

This clinical trial evaluates the feasibility, safety, and tolerability of stereotactic ablative radiotherapy (SABR) using daily adaptive radiation techniques to the prostate fossa and/or pelvic lymph nodes in patients with prostate cancer who have undergone surgical removal of the prostate (radical prostatectomy). For patients with prostate cancer who develop a rising prostate specific antigen (PSA) after radical prostatectomy, salvage radiation therapy is the standard of care treatment. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. All patients receiving salvage radiation following radical prostatectomy typically have treatment directed to the prostate fossa, which is the anatomical region around the operative bed that is at highest risk for containing left over tumor. Many patients receiving salvage radiation therapy can also benefit from treatment of the pelvic lymph nodes. Adaptive radiotherapy is an emerging treatment technique that uses daily imaging to adjust treatment volumes, ensure accurate dose delivery, and allow the use of smaller planning target volume margins. Adaptive radiation is ideally suited for the further implementation of SABR treatment regimens directed to the prostate fossa with or without inclusion of the pelvic lymph nodes. While daily adaptive radiation therapy has been reported in other disease settings, there is currently no data about its use for post-prostatectomy radiation. Using daily adaptive radiation techniques may help researchers learn how to minimize exposure to normal tissue and shorten the number of required treatments to better target the radiation dose in prostate cancer patients post-prostatectomy.

Conditions

• Malignant Prostate Neoplasm

Interventions

PROCEDURE

Computed Tomography

Undergo PET/CT

RADIATION

Image-Guided Adaptive Radiation Therapy

Undergo daily adaptive online replanning for SBRT

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

OTHER

Questionnaire Administration

Ancillary studies

RADIATION

Stereotactic Body Radiation Therapy

Undergo SBRT

Sponsors & Collaborators

• Mayo Clinic

  lead OTHER

Principal Investigators

• Bradley J. Stish, M.D. · Mayo Clinic in Rochester

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-07-28

Primary Completion

2028-05-30

Completion

2029-05-30

Countries

• United States

Study Locations