NCT03486821

Ultra-hypofractionated Radiation in Prostate Cancer

Pilot Trial of Ultra-hypofractionated Radiation in Early Prostate Cancer

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to demonstrate that ultra-hypofractionation of prostate cancer does not increase urinary toxicity as defined by the EPIC-26 GU domain patient reported outcome.

Detailed description

This is a pilot clinical trial looking at 2 fraction SBRT radiation therapy as an alternative to standard of care. Data does not yet exist for the safety and efficacy of this regimen. However, the feasibility of ultra-short radiation therapy treatments has already been demonstrated in an analogous treatment using high-dose rate (HDR) brachytherapy. HDR brachytherapy has been adopted at high volume cancers centers as a standard treatment for prostate cancer. Typical doses have been 26 - 27 Gy over 2 fractions (13 or 13.5 Gy per fraction). Overall, toxicity and efficacy of HDR brachytherapy have compared favorably to other treatment modalities. Dosimetric planning models between SBRT and HDR brachytherapy suggest minor differences. HDR brachytherapy was able to achieve higher intraprostatic maximum doses and lower rectal doses, but target volume coverage and urethral dose was not significantly different. These data suggest that reducing SBRT treatments from 5 fractions to 2 fractions may be feasible, efficacious and tolerable. Eligible patients include all patients who are otherwise eligible for standard 5 fraction SBRT prostate. Study population will be low and intermediate patients with good urinary function (as defined by small prostate volume and low IPSS score). SBRT treatment will be delivered to the prostate to 12.5 Gy x 2 fractions. Hormonal therapy is permitted on this study. Permitted agents include: leuprolide (Lupron/Eligard), biclutamide (Casodex), and degarelix (Firmagon). Rectal sparing with hydrogel spacer (SpaceOAR) will be encouraged. All patients will be enrolled with interim safety analyses after every occurrence of a grade 3 acute or late toxicity. Interval safety analysis will also be performed for recurrence and decrease in EPIC GU domain quality of life. Biospecimen and financial toxicity data will also be collected.

Conditions

• Early Stage Prostate Cancer

Interventions

Type	Name	Description
RADIATION	Hypofractionated Radiation	All patients on this study will receive the same type of therapy, 2 treatment hypofractionated radiation therapy.

Timeline

• Start date: 2018-03-22
• Primary completion: 2025-03-01
• Completion: 2026-03-01
• First posted: 2018-04-03
• Last updated: 2024-09-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study