RecruitingPhase 1NCT04486755

Hypofractionated Accelerated Pelvic Nodal Radiotherapy (GCC 2048)

A Phase I Dose Escalation Study of Hypofractionated Accelerated Pelvic Nodal Radiotherapy Delivered With A Simultaneously Integrated Prostate Boost For Patients With Localized, Intermediate- And High-Risk Prostate Cancer (GCC 2048)


Sponsor

University of Maryland, Baltimore

Enrollment

18 participants

Start Date

Nov 19, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

A phase I trial to determine the safety of delivering three sequentially shorter RT schedules (20, 16, and 12 fractions) of HypoFx pelvic nodal RT in combination with a HypoFx, simultaneous integrated boost (SIB) to the prostate that have been designed to incrementally increased the biological equivalent dose (BED) to prostate cancer, while maintaining a constant BED to normal tissue toxicity.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a faster radiation schedule (fewer, larger doses given over a shorter time) for treating prostate cancer and the surrounding pelvic lymph nodes, compared to the traditional longer course of treatment. The goal is equal effectiveness with a more convenient, shorter treatment timeline. **You may be eligible if...** - You are 18 or older and have a confirmed diagnosis of prostate adenocarcinoma (within 180 days) - You have intermediate- to high-risk prostate cancer requiring treatment of both the prostate and pelvic lymph nodes - Your imaging shows no spread to lymph nodes **You may NOT be eligible if...** - Your cancer has spread to lymph nodes or distant organs - You have had prior pelvic radiation - You have significant inflammatory bowel disease or hip replacement affecting treatment planning Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONHypofractionated Radiation Therapy

All patients RT will be delivered utilizing pencil beam scanning proton therapy. Radiation treatment will be delivered 4 days per week.


Locations(1)

Maryland Proton Treatment Center

Baltimore, Maryland, United States

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NCT04486755


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