Hypofractionated Accelerated Pelvic Nodal Radiotherapy (GCC 2048)

Prostate Cancer Clinical Trial

Official title: 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)

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Outcomes for patients with unfavorable intermediate-risk and high-risk prostate cancer (PC) have been historically poor and are now known to require multimodality treatment. A standard non-surgical treatment option for patients with localized, intermediate and high-risk PC is radiation therapy (RT) in combination with short- or long-term androgen deprivation therapy (ADT).

The benefit of pelvic nodal RT in this setting is unclear, previous studies have been equivocal. There is a growing body of evidence to demonstrate that use of hypofractionated (HypoFx) RT may be a safe method for increasing the dose of RT, while also decreasing normal tissue toxicity. ;

Related Conditions & MeSH terms

• Prostate Adenocarcinoma
• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT04486755
• Study type: Interventional
• Source: University of Maryland, Baltimore
• Contact: Mark Mishra, MD
• Phone: 4103286080
• Email: mmishra@umm.edu
• Status: Recruiting
• Phase: Phase 1
• Start date: November 19, 2020
• Completion date: August 2027