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

Running, not enrolling · Not applicable

Conditions studied: Malignant Prostate Neoplasm

In brief

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.

Key facts

Study ID

NCT05830838

Run by

Mayo Clinic

People needed

50

Starts

2023-07-28

Expected to finish

2029-05-30

Last updated by the study team

2026-05-20

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Males age >= 18 years who are receiving post-operative radiation therapy to the prostate fossa, with or without inclusion of the pelvic lymph nodes, for biochemical recurrences after radical prostatectomy.
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) =< 2.
• Ability to complete questionnaire(s) by themselves or with assistance.
• Provide written informed consent.
• Willingness and ability to complete protocol-specified follow-up (during the active monitoring phase of the study).

You may not qualify if…

• Current evidence of untreated metastatic prostate cancer involving nonregional lymph nodes outside of the bony pelvis, bone, or visceral organs.
• Receipt of cytotoxic chemotherapy within 3 months prior to enrollment.
• Prior radiation therapy to pelvis such that the proposed study treatment volume received 10 Gy or greater.
• Co-morbid severe concurrent disease that would result in a life expectancy of < 5 years.
• Diabetes mellitus-associated vascular ulcers or wounding healing problems, inflammatory bowel disease, or a diagnosed connective tissue disorder.
• Medical or psychiatric conditions that preclude informed decision-making or adherence to study protocols.
• Men of childbearing potential who are unwilling to employ adequate contraception.
• History of a bladder neck contracture, urethral stricture that required dilation, or any surgical repair/reconstruction involving the bladder or urethra other than radical prostatectomy.

Where it is running

• Mayo Clinic in Rochester — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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