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ACTIVE NOT RECRUITING
NCT05628363
NA

Adaptive Stereotactic Body Radiation Therapy to the Prostate and Pelvic Nodes With Simultaneous Integrated Boost to the MR-detected Nodule for Patients With High-risk and Unfavorable Intermediate-risk Prostate Cancer

Sponsor: Washington University School of Medicine

View on ClinicalTrials.gov

Summary

This trial is a prospective clinical trial designed to demonstrate the safety and feasibility of whole-pelvis adaptive prostate stereotactic body radiation therapy (SBRT) with a tumor boost to the magnetic resonance (MR)-detected sites of disease. The hypothesis is that this treatment approach will be safe and feasible with \<15% of patients experiencing an acute CTCAEv5 grade ≥3 genitourinary (GU) or gastrointestinal (GI) adverse event.

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

28

Start Date

2023-01-18

Completion Date

2030-07-25

Last Updated

2025-11-05

Healthy Volunteers

No

Interventions

DEVICE

Ethos Varian treatment system

Device that will be used to administer radiotherapy

RADIATION

Adaptive stereotactic body radiotherapy

Radiotherapy interruptions are acceptable as long as treatments are no more than 16 days apart.

DRUG

Androgen deprivation therapy

Androgen deprivation therapy (ADT) will be administered to study patients according to institutional standard. Patients should initiate ADT beginning no sooner than 60 days prior to start of radiation. ADT is defined as a GnRH agonist/antagonist (leuprolide, goserelin, degarelix, or relugolix). Patients treated with leuprolide, goserelin, or degarelix should also receive an androgen receptor antagonist (flutamide or bicalutamide) for 30 days from the start of GnRH agonist/antagonist or until the end of radiation, depending on institutional standard and physician preference. Agent selection is per treating physician discretion and will be administered per institutional standard and FDA-approved labeling.

Locations (1)

Washington University School of Medicine

St Louis, Missouri, United States