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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Prostate Cancer
Prostate Adenocarcinoma
Interventions Radiation: SIMRT
Radiation: HTIMRT
Enrollment 19
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I: SIMRT Arm II: HTIMRT
Hide Arm/Group Description

'Participants in this group will receive the Standard Fractionated Intensity Modulated Radiotherapy (SIMRT) consisting 40 fractions over 8 weeks.

SIMRT: A total dose of 80 Gy will be delivered in 40 fractions to the Clinical Target Volume (CTV).

All participants in this group will receive the Hypofractionated Targeted Intensity Modulated Radiotherapy (HTIMRT) consisting of a total of 38 fractions over 7.5 weeks.

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.

Period Title: Overall Study
Started 10 9
Completed 8 7
Not Completed 2 2
Reason Not Completed
Lost to Follow-up             1             0
Protocol Violation             1             1
Withdrawal by Subject             0             1
Arm/Group Title Arm I: SIMRT Arm II: HTIMRT Total
Hide Arm/Group Description

'Participants in this group will receive the Standard Fractionated Intensity Modulated Radiotherapy (SIMRT) consisting 40 fractions over 8 weeks.

SIMRT: A total dose of 80 Gy will be delivered in 40 fractions to the Clinical Target Volume (CTV).

Participants in this group will receive the Hypofractionated Targeted Intensity Modulated Radiotherapy (HTIMRT) consisting of 38 fractions over 7.5 weeks.

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.

Total of all reporting groups
Overall Number of Baseline Participants 10 9 19
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 9 participants 19 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
  10.0%
3
  33.3%
4
  21.1%
>=65 years
9
  90.0%
6
  66.7%
15
  78.9%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 9 participants 19 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
10
 100.0%
9
 100.0%
19
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 9 participants 19 participants
Hispanic or Latino
4
  40.0%
5
  55.6%
9
  47.4%
Not Hispanic or Latino
5
  50.0%
4
  44.4%
9
  47.4%
Unknown or Not Reported
1
  10.0%
0
   0.0%
1
   5.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 9 participants 19 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
  11.1%
1
   5.3%
White
10
 100.0%
8
  88.9%
18
  94.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Number of Participants With Biopsy Failure
Hide Description Number of participants showing positive prostate biopsy finding post treatment.
Time Frame Up to 2.25 years
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 19 enrolled participants, only 15 participants were still enrolled at the 2.25 years follow up. Of the 15 participants, only 9 participants were able to complete the post treatment biopsy.
Arm/Group Title Arm I: SIMRT Arm II: HTIMRT
Hide Arm/Group Description:

'Participants in this group will receive the Standard Fractionated Intensity Modulated Radiotherapy (SIMRT) consisting 40 fractions over 8 weeks.

SIMRT: A total dose of 80 Gy will be delivered in 40 fractions to the Clinical Target Volume (CTV).

Participants in this group will receive the Hypofractionated Targeted Intensity Modulated Radiotherapy (HTIMRT) consisting of 38 fractions over 7.5 weeks.

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.

Overall Number of Participants Analyzed 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2
  40.0%
2.Secondary Outcome
Title Toxicity Rate
Hide Description 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.
Time Frame Up to 6 years
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Mortality
Hide Description 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.
Time Frame Up to 6 years
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Failure Rate
Hide Description 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.
Time Frame Up to 6 years
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Health-Related Quality of Life Scores: EPIC SF-12
Hide Description 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.
Time Frame Up to 6 years
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Health-Related Quality of Life Scores: MAX-PC
Hide Description 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.
Time Frame Up to 6 years
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Biomarker Expression in Prostate Tumor Regions
Hide Description 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.
Time Frame Up to 3 years
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Incidence of Circulating Free DNA
Hide Description As assessed from blood samples
Time Frame Up to 3 years
Outcome Measure Data Not Reported
Time Frame Up to 6 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I: SIMRT Arm II: HTIMRT
Hide Arm/Group Description

'Participants in this group will receive the Standard Fractionated Intensity Modulated Radiotherapy (SIMRT) consisting 40 fractions over 8 weeks.

SIMRT: A total dose of 80 Gy will be delivered in 40 fractions to the Clinical Target Volume (CTV).

Participants in this group will receive the Hypofractionated Targeted Intensity Modulated Radiotherapy (HTIMRT) consisting of 38 fractions over 7.5 weeks.

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.

All-Cause Mortality
Arm I: SIMRT Arm II: HTIMRT
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)      1/9 (11.11%)    
Hide Serious Adverse Events
Arm I: SIMRT Arm II: HTIMRT
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/10 (20.00%)      3/9 (33.33%)    
Blood and lymphatic system disorders     
Anemia  1  0/10 (0.00%)  0 1/9 (11.11%)  1
Cardiac disorders     
Acute coronary syndrome  1  0/10 (0.00%)  0 1/9 (11.11%)  1
Musculoskeletal and connective tissue disorders     
Back Pain  1  0/10 (0.00%)  0 1/9 (11.11%)  1
Psychiatric disorders     
Confusion  1  0/10 (0.00%)  0 1/9 (11.11%)  1
Renal and urinary disorders     
Hematuria  1  1/10 (10.00%)  1 0/9 (0.00%)  0
Urinary Incontinence  1  1/10 (10.00%)  1 0/9 (0.00%)  0
Vascular disorders     
Hypotension  1  1/10 (10.00%)  1 0/9 (0.00%)  0
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I: SIMRT Arm II: HTIMRT
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/10 (90.00%)      7/9 (77.78%)    
Blood and lymphatic system disorders     
Polycitemia  1  0/10 (0.00%)  0 1/9 (11.11%)  1
Cardiac disorders     
Chest Pain - Cardiac  1  1/10 (10.00%)  2 1/9 (11.11%)  1
Ear and labyrinth disorders     
Ear Pain  1  2/10 (20.00%)  2 0/9 (0.00%)  0
Hearing impaired  1  1/10 (10.00%)  1 0/9 (0.00%)  0
Tinnitus  1  0/10 (0.00%)  0 1/9 (11.11%)  1
Endocrine disorders     
Low Testosterone  1  1/10 (10.00%)  1 1/9 (11.11%)  1
Gastrointestinal disorders     
Anal hemorrhage  1  1/10 (10.00%)  1 0/9 (0.00%)  0
Constipation  1  3/10 (30.00%)  3 2/9 (22.22%)  2
Diarrhea  1  7/10 (70.00%)  15 2/9 (22.22%)  4
Fecal Incontinence  1  0/10 (0.00%)  0 2/9 (22.22%)  3
Flatulence  1  1/10 (10.00%)  1 1/9 (11.11%)  1
Blood on Rectum  1  1/10 (10.00%)  1 0/9 (0.00%)  0
Hard Stool  1  0/10 (0.00%)  0 1/9 (11.11%)  1
Hemorrhoids  1  1/10 (10.00%)  1 0/9 (0.00%)  0
Proctitis  1  1/10 (10.00%)  2 1/9 (11.11%)  1
Rectal Hemorrhage  1  0/10 (0.00%)  0 1/9 (11.11%)  1
Rectal Pain  1  2/10 (20.00%)  2 0/9 (0.00%)  0
Abdominal Pain  1  1/10 (10.00%)  1 0/9 (0.00%)  0
Bloating  1  1/10 (10.00%)  1 0/9 (0.00%)  0
Dyspepsia  1  1/10 (10.00%)  1 0/9 (0.00%)  0
Gastroesophageal reflux disease  1  1/10 (10.00%)  1 0/9 (0.00%)  0
Nausea  1  2/10 (20.00%)  2 1/9 (11.11%)  1
Vomiting  1  0/10 (0.00%)  0 1/9 (11.11%)  1
General disorders     
Edema Limbs  1  1/10 (10.00%)  2 4/9 (44.44%)  4
Fatigue  1  5/10 (50.00%)  5 6/9 (66.67%)  9
Fever  1  0/10 (0.00%)  0 1/9 (11.11%)  1
Pain  1  0/10 (0.00%)  0 1/9 (11.11%)  1
Infections and infestations     
Papulopustular rash  1 [1]  1/10 (10.00%)  1 1/9 (11.11%)  1
Upper Respiratory Infection  1  0/10 (0.00%)  0 2/9 (22.22%)  2
Penile Infection  1  1/10 (10.00%)  1 0/9 (0.00%)  0
Skin Infection  1  1/10 (10.00%)  1 2/9 (22.22%)  2
Injury, poisoning and procedural complications     
Fall  1  2/10 (20.00%)  2 0/9 (0.00%)  0
Wound dehiscence  1  1/10 (10.00%)  1 1/9 (11.11%)  1
Wrist fracture  1  1/10 (10.00%)  1 0/9 (0.00%)  0
Investigations     
Low Testosterone  1  1/10 (10.00%)  1 1/9 (11.11%)  1
Creatinine Increased  1  0/10 (0.00%)  0 1/9 (11.11%)  1
Platelet count decreased  1  0/10 (0.00%)  0 1/9 (11.11%)  1
Weight gain  1  1/10 (10.00%)  1 0/9 (0.00%)  0
Metabolism and nutrition disorders     
Hypertriglyceridemia  1  1/10 (10.00%)  1 1/9 (11.11%)  1
Hyperglycemia  1  0/10 (0.00%)  0 1/9 (11.11%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/10 (10.00%)  1 0/9 (0.00%)  0
Back Pain  1  1/10 (10.00%)  1 1/9 (11.11%)  1
Bone Pain  1  1/10 (10.00%)  1 0/9 (0.00%)  0
Neck Pain  1  1/10 (10.00%)  1 0/9 (0.00%)  0
Pain in Extremity  1 [2]  0/10 (0.00%)  0 1/9 (11.11%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal Cell Carcinoma  1  1/10 (10.00%)  1 1/9 (11.11%)  1
Irritated Seborrheic Keratosis  1  0/10 (0.00%)  0 1/9 (11.11%)  1
Nervous system disorders     
Dizziness  1  3/10 (30.00%)  6 0/9 (0.00%)  0
Headache  1  1/10 (10.00%)  2 0/9 (0.00%)  0
Movements involuntary  1  0/10 (0.00%)  0 1/9 (11.11%)  2
Seizure  1  0/10 (0.00%)  0 1/9 (11.11%)  1
Psychiatric disorders     
Depression  1  0/10 (0.00%)  0 1/9 (11.11%)  2
Libido decreased  1  2/10 (20.00%)  2 1/9 (11.11%)  1
Renal and urinary disorders     
Cystitis noninfective  1  8/10 (80.00%)  15 6/9 (66.67%)  6
Hematuria  1  2/10 (20.00%)  4 1/9 (11.11%)  1
Renal and Urinary Disorder - Other  1  1/10 (10.00%)  1 0/9 (0.00%)  0
Urinary Frequency  1  7/10 (70.00%)  19 7/9 (77.78%)  10
Urinary Incontinence  1  6/10 (60.00%)  11 3/9 (33.33%)  5
Urinary Retention  1  4/10 (40.00%)  8 3/9 (33.33%)  6
Urinary Tract Infection  1  2/10 (20.00%)  2 1/9 (11.11%)  1
Urinary Tract Obstruction  1  0/10 (0.00%)  0 1/9 (11.11%)  1
Urinary Tract Pain  1  0/10 (0.00%)  0 1/9 (11.11%)  1
Urinary Urgency  1  9/10 (90.00%)  21 6/9 (66.67%)  12
Reproductive system and breast disorders     
Ejaculation Disorder  1  1/10 (10.00%)  1 3/9 (33.33%)  3
Erectile Dysfunction  1  4/10 (40.00%)  4 3/9 (33.33%)  6
Pelvic Pain  1  1/10 (10.00%)  1 0/9 (0.00%)  0
Penile Pain  1  1/10 (10.00%)  1 0/9 (0.00%)  0
Prostatic Obstruction  1  1/10 (10.00%)  1 1/9 (11.11%)  1
Low Testosterone  1  1/10 (10.00%)  1 0/9 (0.00%)  0
Testicular Disorder  1 [3]  1/10 (10.00%)  1 0/9 (0.00%)  0
Testicular Disorder  1 [4]  0/10 (0.00%)  0 1/9 (11.11%)  1
Testicular Pain  1  1/10 (10.00%)  1 1/9 (11.11%)  2
Respiratory, thoracic and mediastinal disorders     
Cough  1  0/10 (0.00%)  0 1/9 (11.11%)  1
Nasal congestion  1  1/10 (10.00%)  1 0/9 (0.00%)  0
Sore throat  1  1/10 (10.00%)  1 0/9 (0.00%)  0
Wheezing  1  0/10 (0.00%)  0 1/9 (11.11%)  1
Skin and subcutaneous tissue disorders     
Erythema multiforme  1  2/10 (20.00%)  3 0/9 (0.00%)  0
Pruritus  1  0/10 (0.00%)  0 1/9 (11.11%)  1
Squamous Cell Carcinoma in SITU Bowens Disease  1  0/10 (0.00%)  0 1/9 (11.11%)  1
Skin ulceration  1  1/10 (10.00%)  1 0/9 (0.00%)  0
Urticaria  1  0/10 (0.00%)  0 1/9 (11.11%)  1
Vascular disorders     
Hot Flashes  1  1/10 (10.00%)  1 1/9 (11.11%)  1
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
[1]
Testicular tenderness
[2]
Right knee pain
[3]
Atrophic testicle
[4]
Decreased Testosterone Level
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Alan Pollack MD, PhD
Organization: University of Miami
Phone: 305-243-4916
EMail: apollack@med.miami.edu
Layout table for additonal information
Responsible Party: Alan Pollack, MD, PhD, University of Miami
ClinicalTrials.gov Identifier: NCT01411332    
Other Study ID Numbers: 20100635
First Submitted: August 3, 2011
First Posted: August 8, 2011
Results First Submitted: May 21, 2021
Results First Posted: July 30, 2021
Last Update Posted: July 30, 2021