NCT01411332

Hypofractionated Image-Guided Radiotherapy For Prostate Cancer: The HEIGHT Trial

A Phase III Trial of Hypofractionated External Beam Image-Guided Highly Targeted Radiotherapy: The HEIGHT Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: University of Miami · Academic / Other
• Sex: Male
• Age: 35 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

1. Delivery of directed hypofractionated targeted (HT) radiotherapy (RT) tumor boost to the dominant tumor lesion in the prostate as identified by multiparametric MRI will increase tumor eradication from the prostate. 2. Biomarker expression levels differ in the multiparametric MRI defined regions at high risk of harboring tumors that determine outcome. 3. 10-15% of men undergoing RT have Circulating DNA or tumor cells (CTC) that are related to an adverse treatment outcome. 4. Quality of life will not differ significantly between the treatment arms. 5. Prostate cancer-related anxiety will be reduced in the HTIMRT arm, because the patients will be aware that the dominant tumor will be targeted with higher radiation dose.

Conditions

• Prostate Cancer
• Prostate Adenocarcinoma

Interventions

Type	Name	Description
RADIATION	SIMRT	A total dose of 80 Gy will be delivered in 40 fractions to the Clinical Target Volume (CTV).
RADIATION	HTIMRT	Dose escalation to the Multiparametric MRI (MP-MRI) by dose painting at 2.35-2.40 Gy per fraction, while the rest of the Clinical Target Volume (CTV) receives 2.0 Gy a fraction to 76 Gy. The hypofractionated targeted (HT) boost region will receive an absolute dose of 89.3-91.2 Gy. Assuming an α/β ratio of 3.0, this would be equivalent to 95.5 Gy in 2.0 Gy fractions.

Timeline

• Start date: 2011-10-31
• Primary completion: 2017-07-11
• Completion: 2021-11-22
• First posted: 2011-08-08
• Last updated: 2023-05-22
• Results posted: 2021-07-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study