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

NCT ID: NCT01411332

Last Updated: 2023-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2021-11-22

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.

Conditions

Prostate Cancer; Prostate Adenocarcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I: SIMRT

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

Group Type: ACTIVE_COMPARATOR

SIMRT

Intervention Type: RADIATION

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

Arm II: HTIMRT

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

Group Type: ACTIVE_COMPARATOR

HTIMRT

Intervention Type: 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.

Interventions

SIMRT

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

Intervention Type: 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.

Intervention Type: RADIATION

Other Intervention Names

Standard Fractionated Intensity Modulated Radiotherapy; Hypofractionated Targeted Intensity Modulated Radiotherapy

Eligibility 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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Alan Pollack, MD, PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alan Pollack, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami

Miami, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

20100635

Identifier Type: -

Identifier Source: org_study_id