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

University of Miami1 site in 1 country18 target enrollmentOctober 31, 2011

Overview

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.
Biomarker expression levels differ in the multiparametric MRI defined regions at high risk of harboring tumors that determine outcome.
10-15% of men undergoing RT have Circulating DNA or tumor cells (CTC) that are related to an adverse treatment outcome.
Quality of life will not differ significantly between the treatment arms.
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.

Registry

clinicaltrials.gov

Start Date

October 31, 2011

End Date

November 22, 2021

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Sponsor

Responsible Party

Principal Investigator

Alan Pollack, MD, PhD

Professor

University of Miami

•A. Biopsy confirmed adenocarcinoma of the prostate.
•B. T1-T3a disease based on digital rectal exam.
•T1a is permitted if peripheral zone biopsies are positive.
•T3a disease based on MRI is acceptable.
•C. No evidence of metastasis by any clinical criteria or available radiographic tests.
•D. Gleason score 6-
•E. Patients with Gleason score 8 must be offered long term androgen deprivation therapy (ADT) and refuse such treatment because only 4-6 (±2 months) months (short term ADT) is permitted on this protocol. Gleason score ≥ 8 patients should be recommended to receive short term ADT in conjunction with RT. When given, the ADT recommended to begin after fiducial marker placement, if applicable; however, ADT is permitted to have been started up to two months prior to the signing of consent.
•Patients with Gleason score 8 disease must have \<40 of the diagnostic tumor tissue involved with tumor.
•Patients with Gleason score ≤7 may be treated with 4-6 (±2 months) months of ADT.
•F. PSA ≤100 ng/mL within 3 months of enrollment. If PSA was above 100 and dropped to ≤100 with antibiotics, this is acceptable for enrollment.

Number of Participants With Biopsy Failure

Time Frame: Up to 2.25 years

Number of participants showing positive prostate biopsy finding post treatment.

Toxicity Rate(Up to 6 years)
Mortality(Up to 6 years)
Failure Rate(Up to 6 years)
EPIC SF-12 Scores(At baseline, at last week of treatment (Up to 8 weeks), at 6 weeks after treatment (Up to 14 weeks), at 3 months after treatment (Up to 20 weeks), at 9 months after treatment (Up to 44 weeks).)
MAX-PC Scores(At baseline, at last week of treatment (Up to 8 weeks), at 6 weeks after treatment (Up to 14 weeks), at 3 months after treatment (Up to 20 weeks), at 9 months after treatment (Up to 44 weeks))
Biomarker Expression in Prostate Tumor Regions(Up to 3 years)
Incidence of Circulating Free DNA(Up to 3 years)