Hypofractionated Image-Guided Radiotherapy For Prostate Cancer: The HEIGHT Trial

NCT01411332 | Completed Results DMC FDA Device

• 1 other identifier: 20100635
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.Biomarker expression levels differ in the multiparametric MRI defined regions at high risk of harboring tumors that determine outcome.
3. 3.10-15% of men undergoing RT have Circulating DNA or tumor cells (CTC) that are related to an adverse treatment outcome.
4. 4.Quality of life will not differ significantly between the treatment arms.
5. 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.

Conditions

Prostate Cancer; Prostate Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Biopsy Failure

  Number of participants showing positive prostate biopsy finding post treatment.

  Up to 2.25 years

Secondary Outcomes (7)

• Toxicity Rate

  Up to 6 years

• Mortality

  Up to 6 years

• Failure Rate

  Up to 6 years

• EPIC SF-12 Scores

  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

  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)

Study Arms (2)

Arm I: SIMRT

ACTIVE COMPARATOR

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

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.

Radiation: HTIMRT

Interventions

SIMRT RADIATION

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

Also known as: Standard Fractionated Intensity Modulated Radiotherapy

Arm I: SIMRT

HTIMRT RADIATION

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.

Also known as: Hypofractionated Targeted Intensity Modulated Radiotherapy

Arm II: HTIMRT

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Alan Pollack MD, PhD
• Organization: University of Miami

apollack@med.miami.edu

305-243-4916

Study Officials

• Alan Pollack, MD, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 3, 2011
• First Posted: August 8, 2011
• Study Start: October 31, 2011
• Primary Completion: July 11, 2017
• Study Completion: November 22, 2021
• Last Updated: May 22, 2023
• Results First Posted: July 30, 2021

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)