Hypofractionated Image-Guided Radiotherapy For Prostate Cancer: The HEIGHT Trial (HEIGHT)
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|ClinicalTrials.gov Identifier: NCT01411332|
Recruitment Status : Active, not recruiting
First Posted : August 8, 2011
Last Update Posted : December 11, 2020
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Prostate Adenocarcinoma||Radiation: SIMRT Radiation: HTIMRT||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase III Trial of Hypofractionated External Beam Image-Guided Highly Targeted Radiotherapy: The HEIGHT Trial|
|Actual Study Start Date :||October 31, 2011|
|Actual Primary Completion Date :||July 11, 2017|
|Estimated Study Completion Date :||January 15, 2022|
Active Comparator: Arm I: SIMRT
'Participants in this group will receive the Standard Fractionated Intensity Modulated Radiotherapy (SIMRT) consisting 40 fractions over 8 weeks.
A total dose of 80 Gy will be delivered in 40 fractions to the Clinical Target Volume (CTV).
Other Name: Standard Fractionated Intensity Modulated Radiotherapy
Active Comparator: Arm II: HTIMRT
Participants in this group will receive the Hypofractionated Targeted Intensity Modulated Radiotherapy (HTIMRT) consisting of 38 fractions over 7.5 weeks.
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.
Other Name: Hypofractionated Targeted Intensity Modulated Radiotherapy
- Biopsy Failure Rate [ Time Frame: Up to 3 years ]The proportion of positive prostate biopsy findings among patients without clinical or biochemical failure
- Toxicity Rate [ Time Frame: Up to 5.25 years ]Acute and Late Toxicity will be evaluated by treating physician using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0. Acute toxicity will be defined as any treatment related adverse event during and within 3 months of completing treatment. Late Toxicity will be defined as any treatment related adverse events occurring more than 3 months after treatment completion.
- Health-Related Quality of Life Scores: EPIC SF-12 [ Time Frame: Up to 5.25 years ]Health-related Quality of Life (HRQOL) will be measured using the Expanded Prostate Cancer Index Composite and Medical Outcomes Study SF-12 (EPIC SF-12) to evaluate patient function and satisfaction after prostate cancer treatment. Response options for each item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better HRQOL.
- Health-Related Quality of Life Scores: MAX-PC [ Time Frame: Up to 5.25 years ]Health-related quality of life (HRQOL) will be measured using the scores on the Modified 18-item Memorial Anxiety Scale for Prostate Cancer (MAX-PC) from pre-treatment to post-treatment. The scale consists of 18 items (e.g. "I thought about prostate cancer even though I didn't mean to.") scored on a scale from 0 ("not at all") to 3 ("often"). Total scores range from 0 to 54, with higher scores indicating higher levels of anxiety.
- Biomarker expression in prostate tumor regions [ Time Frame: Up to 3 years ]The amount of biomarker expression will be evaluated via immunohistochemistry (IHC) from ultrasound guided prostate biopsy tissue samples for both functional MRI suspicious regions and those that are not suspicious.
- Incidence of circulating free DNA [ Time Frame: Up to 3 years ]As assessed from blood samples
- Failure Rate [ Time Frame: Up to 5.25 years ]Failure rate will be reported as the incidence of biochemical or clinical failure. Biochemical failure is defined is an increase of 2 or greater from nadir of Prostate Specific Antigen (PSA) levels. Clinical Failure is defined as newly identified extension outside the prostate after initial regression, or urinary obstructive symptoms with carcinoma or regional/distant failure due to radiographic evidence metastasis.
- Mortality [ Time Frame: Up to 5.25 years ]Mortality will be reported as overall survival and failure free survival. Overall survival is defined as the elapsed time from start of radiotherapy to death from any cause. Failure free survival is defined as the elapsed time from start of radiotherapy to first documented evidence of biochemical or clinical failure or death from any cause, whichever occurs first. In the absence of any event defining failure, follow-up time will be censored at the date of last documented failure-free status.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01411332
|United States, Florida|
|University of Miami|
|Miami, Florida, United States, 33136|
|Principal Investigator:||Alan Pollack, MD, PhD||University of Miami|