Prostate CancerHEIGHTNCT01411332
Hypofractionated Image-Guided Radiotherapy For Prostate Cancer: The HEIGHT Trial
A study testing SIMRT and HTIMRT in people with Prostate Cancer and Prostate Adenocarcinoma, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 85 years, men only
- Conditions the study is for
- Prostate Cancer, Prostate Adenocarcinoma
- What is being tested?
- SIMRT and HTIMRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2011to 22 Nov 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 23Show fewer
- 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.
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Prostate Cancer, Prostate Adenocarcinoma
- Being tested
- SIMRT, HTIMRT
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIMRTRadiation
Also called Standard Fractionated Intensity Modulated Radiotherapy
A total dose of 80 Gy will be delivered in 40 fractions to the Clinical Target Volume (CTV).
HTIMRTRadiation
Also called Hypofractionated Targeted Intensity Modulated Radiotherapy
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm I: SIMRT | Active comparator | 'Participants in this group will receive the Standard Fractionated Intensity Modulated Radiotherapy (SIMRT) consisting 40 fractions over 8 weeks. Receives: Radiation: SIMRT |
| Arm II: HTIMRT | Active comparator | Participants in this group will receive the Hypofractionated Targeted Intensity Modulated Radiotherapy (HTIMRT) consisting of 38 fractions over 7.5 weeks. Receives: Radiation: HTIMRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Biopsy Failure
Number of participants showing positive prostate biopsy finding post treatment.
Measured: Up to 2.25 years
Secondary outcomes (7)
Toxicity Rate
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.
Measured: Up to 6 years
Mortality
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.
Measured: Up to 6 years
Failure Rate
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.
Measured: Up to 6 years
EPIC SF-12 Scores
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.
Measured: 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
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.
Measured: 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
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.
Measured: Up to 3 years
Incidence of Circulating Free DNA
Incidence of circulating free DNA, as assessed from blood samples.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2011 (estimated)
- Study start31 Oct 2011
- Primary completion11 Jul 2017
- Study completion22 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alan Pollack, MD, PhD, University of Miami
- Investigators
- Alan Pollack, MD, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01411332
- Sponsor's protocol ID
- 20100635
- Acronym
- HEIGHT
- Status last verified
- Apr 2023
- First submitted
- 3 Aug 2011
- Last updated
- 22 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Trial of Hypofractionated External Beam Image-Guided Highly Targeted Radiotherapy: The HEIGHT Trial
- ClinicalTrials.gov ID
- NCT01411332
- Acronym / sponsor ID
- HEIGHT / 20100635
- Conditions
- Prostate Cancer, Prostate Adenocarcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 31 Oct 2011 (actual)
- Primary completion
- 11 Jul 2017 (actual)
- Study completion
- 22 Nov 2021 (actual)
- First posted
- 8 Aug 2011 (estimated)
- Results
- Posted 30 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I: SIMRT | Active comparator | Radiation: SIMRT'Participants in this group will receive the Standard Fractionated Intensity Modulated Radiotherapy (SIMRT) consisting 40 fractions over 8 weeks. |
| Arm II: HTIMRT | Active comparator | Radiation: HTIMRTParticipants in this group will receive the Hypofractionated Targeted Intensity Modulated Radiotherapy (HTIMRT) consisting of 38 fractions over 7.5 weeks. |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- A. Biopsy confirmed adenocarcinoma of the prostate.
- B. T1-T3a disease based on digital rectal exam.
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SIMRTAlso: Standard Fractionated Intensity Modulated RadiotherapyA total dose of 80 Gy will be delivered in 40 fractions to the Clinical Target Volume (CTV). | Radiation | Arm I: SIMRT |
| HTIMRTAlso: Hypofractionated Targeted Intensity Modulated RadiotherapyDose 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. | Radiation | Arm II: HTIMRT |
Primary outcome
Number of Participants With Biopsy Failure
Time frame: Up to 2.25 years
Number of participants showing positive prostate biopsy finding post treatment.
7 secondary outcomes
Toxicity Rate
Time frame: Up to 6 years
Mortality
Time frame: Up to 6 years
Failure Rate
Time frame: 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).
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)
Biomarker Expression in Prostate Tumor Regions
Time frame: Up to 3 years
Incidence of Circulating Free DNA
Time frame: Up to 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan Pollack, MD, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SIMRT and HTIMRT in people with Prostate Cancer and Prostate Adenocarcinoma, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Biopsy Failure (time frame: Up to 2.25 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2023.