- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01411332
Hypofractionated Image-Guided Radiotherapy For Prostate Cancer: The HEIGHT Trial (HEIGHT)
A Phase III Trial of Hypofractionated External Beam Image-Guided Highly Targeted Radiotherapy: The HEIGHT Trial
- 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33136
- University of Miami
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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 6-8.
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.
- G. If PSA is >15 ng/ml or there is ≥ Gleason 8 disease, a bone scan should be obtained ≤4 months before enrollment and should be without evidence of metastasis. A questionable bone scan is acceptable if plain x-rays, CT and/or MRI are negative for metastasis.
- H. No previous pelvic radiotherapy
- I. No previous history of radical/total prostatectomy (suprapubic prostatectomy is acceptable)
- J. No concurrent, active malignancy, other than nonmetastatic skin cancer or early stage chronic lymphocytic leukemia (well-differentiated small cell lymphocytic lymphoma). If a prior malignancy is in remission for ≥ 5 years then the patient is eligible.
K. Identifiable multiparameter functional MRI defined tumor lesion or lesions using a 1.5T or 3.0T MRI (3.0T preferable), that total in volume <33% of the prostate within 3 months prior to enrollment.
a. Multiparametric functional including diffusion weighted imaging (DWI) of prostate and pelvis is required prior to protocol consideration
- L. Ability to understand and the willingness to sign a written informed consent document
- M. Zubrod performance status <2 (Karnofsky or Eastern Cooperative Oncology Group (ECOG) performance status may be used to estimate Zubrod)
- N. Willingness to fill out quality of life/psychosocial forms.
- O. Age ≥35 and ≤85 years.
- P. Serum testosterone is within 40% of normal assay limits (e.g., x=0.4*lower assay limit and x=.04*upper assay limit + upper assay limit),, taken within 4 months of enrollment. Patients who have been started on ADT prior to signing consent are not required to have a serum testosterone at this level prior to signing consent; but, a serum testosterone prior to fiducial marker placement is recommended.
- Q. Serum liver function tests (LFTs) taken within 3 months of enrollment.
- R. Complete blood counts taken within 3 months of enrollment.
Exclusion Criteria
- A. Previous pelvic radiotherapy.
- B. Previous history of radical prostatectomy.
- C. Concurrent, active malignancy, which is not nonmetastatic skin cancer or early stage chronic lymphocytic leukemia (well-differentiated small cell lymphocytic lymphoma). If a prior malignancy is in remission for < 5 years then the patient is not eligible
- D. Not willing to fill out quality of life/psychosocial questionnaires.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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 Names:
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Biopsy Failure
Time Frame: Up to 2.25 years
|
Number of participants showing positive prostate biopsy finding post treatment.
|
Up to 2.25 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality
Time Frame: Up to 6 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.
|
Up to 6 years
|
Failure Rate
Time Frame: Up to 6 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.
|
Up to 6 years
|
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.
|
Up to 3 years
|
Toxicity Rate
Time Frame: Up to 6 years
|
Toxicity rate will be reported as the number of participants experiencing any treatment-related adverse events.
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.
|
Up to 6 years
|
EPIC SF-12 Scores
Time Frame: 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).
|
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.
|
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
Time Frame: 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)
|
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).
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.
|
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)
|
Incidence of Circulating Free DNA
Time Frame: Up to 3 years
|
Incidence of circulating free DNA, as assessed from blood samples.
|
Up to 3 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alan Pollack, MD, PhD, University of Miami
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20100635
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Prostate Cancer
-
Roswell Park Cancer InstituteRecruitingObesity | Overweight | Cancer Survivor | Prostate Adenocarcinoma | Stage I Prostate Cancer | Stage II Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate Cancer | Stage IVA Prostate Cancer | Stage IVB Prostate Cancer | Stage A Prostate Cancer | Stage... and other conditionsUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Regeneron Pharmaceuticals; Prostate Cancer FoundationWithdrawnStage III Prostate Cancer | Stage IV Prostate Cancer | Stage IVA Prostate Cancer | Stage IVB Prostate Cancer | Stage IIIA Prostate Cancer | Stage IIIB Prostate Cancer | Stage IIIC Prostate Cancer
-
University of Southern CaliforniaNational Cancer Institute (NCI); SanofiTerminatedDiarrhea | Recurrent Prostate Cancer | Hormone-resistant Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Ryan Kohlbrenner, MDRadiological Society of North AmericaCompletedProstate Adenocarcinoma | Stage IV Prostate Cancer AJCC v8 | Prostate Carcinoma | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IVA Prostate Cancer AJCC v8 | Stage...United States
-
Jonsson Comprehensive Cancer CenterProgenics Pharmaceuticals, Inc.TerminatedRandomized Trial of PSMA PET Scan Before Definitive Radiation Therapy for Prostate Cancer (PSMA-dRT)Stage II Prostate Cancer AJCC v8 | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IIA Prostate Cancer AJCC v8 | Stage IIB Prostate Cancer AJCC v8 | Stage I Prostate...United States
-
Ohio State University Comprehensive Cancer CenterRiverside Methodist HospitalCompletedStage I Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
University of California, IrvineCompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
NRG OncologyNational Cancer Institute (NCI)RecruitingProstate Adenocarcinoma | Stage I Prostate Cancer AJCC v8 | Stage II Prostate Cancer AJCC v8 | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IVA Prostate Cancer... and other conditionsUnited States
-
Mayo ClinicNational Cancer Institute (NCI)WithdrawnStage I Prostate Cancer AJCC v8 | Stage II Prostate Cancer AJCC v8 | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IIA Prostate Cancer AJCC v8 | Stage IIB Prostate...United States