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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
Results First Posted : July 30, 2021
Last Update Posted : July 30, 2021
Sponsor:
Information provided by (Responsible Party):
Alan Pollack, MD, PhD, University of Miami

Brief 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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Prostate Adenocarcinoma Radiation: SIMRT Radiation: HTIMRT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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.
Radiation: SIMRT
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.
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.
Other Name: Hypofractionated Targeted Intensity Modulated Radiotherapy




Primary Outcome Measures :
  1. Number of Participants With Biopsy Failure [ Time Frame: Up to 2.25 years ]
    Number of participants showing positive prostate biopsy finding post treatment.


Secondary Outcome Measures :
  1. Toxicity Rate [ Time Frame: Up to 6 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.

  2. 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.

  3. 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.

  4. Health-Related Quality of Life Scores: EPIC SF-12 [ Time Frame: Up to 6 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.

  5. Health-Related Quality of Life Scores: MAX-PC [ Time Frame: Up to 6 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.

  6. 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.

  7. Incidence of Circulating Free DNA [ Time Frame: Up to 3 years ]
    As assessed from blood samples



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   35 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A. Biopsy confirmed adenocarcinoma of the prostate.
  • B. T1-T3a disease based on digital rectal exam.

    1. T1a is permitted if peripheral zone biopsies are positive.
    2. 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.

    1. Patients with Gleason score 8 disease must have <40 of the diagnostic tumor tissue involved with tumor.
    2. 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.

Information from the National Library of Medicine

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


Locations
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United States, Florida
University of Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Investigators
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Principal Investigator: Alan Pollack, MD, PhD University of Miami
  Study Documents (Full-Text)

Documents provided by Alan Pollack, MD, PhD, University of Miami:
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Responsible Party: Alan Pollack, MD, PhD, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT01411332    
Other Study ID Numbers: 20100635
First Posted: August 8, 2011    Key Record Dates
Results First Posted: July 30, 2021
Last Update Posted: July 30, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases