Description:
The purpose of this research study is to learn about: 1) improving control of prostate cancer
using an extra high dose radiation treatment to the MRI defined high risk tumor areas, in
addition to the standard radiation treatment to the rest of the prostate; 2) preserving
quality of life by reducing dose to the nearby organs at risk around the prostate; and 3)
establishing the relationship of pre- and post-treatment MRI to MRI-directed biopsy results
at 2-2.5 years after treatment.
Title
- Brief Title: Randomized MRI-Guided Prostate Boosts Via Initial Lattice Stereotactic vs Daily Moderately Hypofractionated Radiotherapy
- Official Title: A Phase II Randomized Trial of MRI-Guided Prostate Boosts Via Initial Lattice Stereotactic vs Daily Moderately Hypofractionated Radiotherapy - The Miami BLaStM Trial
Clinical Trial IDs
- ORG STUDY ID:
20140627
- NCT ID:
NCT02307058
Conditions
Purpose
The purpose of this research study is to learn about: 1) improving control of prostate cancer
using an extra high dose radiation treatment to the MRI defined high risk tumor areas, in
addition to the standard radiation treatment to the rest of the prostate; 2) preserving
quality of life by reducing dose to the nearby organs at risk around the prostate; and 3)
establishing the relationship of pre- and post-treatment MRI to MRI-directed biopsy results
at 2-2.5 years after treatment.
Trial Arms
Name | Type | Description | Interventions |
---|
LEAD RT Group | Experimental | Participants in this group will receive the Lattice Extreme Ablative Dose (LEAD) radiotherapy. Radiotherapy will begin within two months of fiducial marker placement. The therapy will consist of 39 fractions over approximately 8 weeks. | |
HEIGHT RT Group | Experimental | Participants in this group will receive the Hypofractionated Extended Image-Guided Highly Targeted (HEIGHT) radiotherapy. Radiotherapy will begin within two months of fiducial marker placement. The therapy will consist of 39 fractions over approximately 7 and a half weeks. | |
Eligibility Criteria
Eligibility Criteria:
- A. Biopsy confirmed adenocarcinoma (including ductal) of the prostate.
- B. T1-T3 disease based on digital rectal exam.
- C. No evidence of metastasis by any clinical criteria or available radiographic tests
(N0M0 by clinical or imaging criteria).
- D. Gleason score 6-10.
- E. Androgen deprivation therapy (ADT) is at the discretion of the treating physician;
but, must be decided (none, short-term or long-term as counted from the luteinizing
hormone-releasing hormone (LHRH) agonist or antagonist injection) prior to enrollment.
An anti-androgen (e.g., bicalutamide at 50 mg per day po) is recommended to start
prior to LHRH agonist injection (not recommended for LHRH antagonist injection) and is
recommended to not be administered for more than 4 months. If ADT is planned, the
following restrictions apply:
- i. It may be initiated no more than 3 months prior to the signing of consent
- ii. It must be started prior to the start of radiotherapy and
- iii. The total length planned must be ≤ 30 months
- F. Prostate-specific Antigen (PSA) ≤ 100 ng/mL within (+/-) 4 months of signing of
consent. If PSA was above 100 and drops to ≤ 100 with antibiotics, this is acceptable
for enrollment.
- G. Subjects with T3 disease based on digital rectal exam (DRE), Gleason 8-10 or a PSA
of >15 ng/ml, should have a bone scan within (+/-) 4 months of signing of consent that
is without evidence of metastasis. A questionable bone scan is acceptable if
additional imaging studies (e.g., plain x-rays, CT, or MRI) do not confirm for
metastasis.
- H. Suspicious peripheral zone or central gland lesion on MP-MRI
- i. Peripheral zone: Distinct lesion on dynamic contrast-enhanced MRI (DCE-MRI)
with early enhancement and later washout (Note: contrast not required for
enrollment), and/or distinct lesion on the ADC map (Value <1000).
- ii. Central gland: A suspicious central gland lesion on MP-MRI must have a
distinct lesion on the apparent diffusion coefficient (ADC) map (Value <1000)
- I. No previous pelvic radiotherapy.
- J. No previous history of radical/total prostatectomy (suprapubic prostatectomy is
acceptable).
- K. 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.
- 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 at signing of consent.
Maximum Eligible Age: | 85 Years |
Minimum Eligible Age: | 35 Years |
Eligible Gender: | Male |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Rate of Prostate Tumor PathCR |
Time Frame: | Up to 3 years |
Safety Issue: | |
Description: | Prostate Tumor Pathologic Complete Response (PathCR) will be measured using standard ultrasound guided systematic prostate biopsy. |
Secondary Outcome Measures
Measure: | Correlation between Pathologic Complete Response (PathCR) and Changes in serial post-RT MRIs |
Time Frame: | 3 months post-RT, 9-months post-RT, within 3 months of 2-2.5 post-treatment biopsy |
Safety Issue: | |
Description: | To establish the relationship between PathCR and changes in serial post-RT MRI's obtained at 3 months and 9 months after RT, and within 3 months prior to the primary endpoint post-treatment prostate biopsy at 2.0-2.5 yr after completion of all therapy. |
Measure: | Number of participants experiencing treatment related adverse events |
Time Frame: | Up to 2 years |
Safety Issue: | |
Description: | Number of participants experiencing acute and late toxicity will be evaluated by treating physicians |
Measure: | Health-Related Quality of Life Scores: EPIC SF-12 |
Time Frame: | Up to 5.25 years (post-treatment) |
Safety Issue: | |
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. |
Measure: | Health-Related Quality of Life Scores: MAX-PC |
Time Frame: | Up to 5.25 years (post-treatment) |
Safety Issue: | |
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. |
Measure: | Health-Related Quality of Life Scores: IPSS |
Time Frame: | Up to 5.25 years (post-treatment) |
Safety Issue: | |
Description: | Health-related quality of life (HRQOL) will be measured using the International Prostate Symptom Score (IPSS) to evaluate patient urinary function and quality of life. There are 7 questions related to urinary function. Responses are on a scale from 0 ("not at all") to 5 ("almost always"), with higher scores indicating higher levels of urinary dysfunction. There is 1 quality of life question related to urinary symptoms. Responses are on a scale from 0 ("delighted") to 6 ("terrible"). |
Measure: | Change in gene/biomarker expression |
Time Frame: | Baseline, Up to 5.25 years (post-treatment) |
Safety Issue: | |
Description: | Change in gene/biomarker expression in different MP-MRI tumor regions assessed from prostate biopsy samples. |
Measure: | Rate of participant response |
Time Frame: | Up to 5.25 years (post-treatment) |
Safety Issue: | |
Description: | Participant response will be reported as the percentage of participants with reported biochemical failure (defined as having an increase of 2 ng/mL PSA levels from nadir), clinical failure (defined as having evidence of distant metastasis and overall failure), cause specific mortality and overall mortality. |
Measure: | Change in CTC Levels |
Time Frame: | Baseline (pre-treatment), Up to 2 years (post-treatment) |
Safety Issue: | |
Description: | Circulating Tumor Cell (CTC) levels evaluated from peripheral blood samples. |
Measure: | Change in CCAF Levels |
Time Frame: | Baseline (pre-treatment), Up to 2 years (post-treatment) |
Safety Issue: | |
Description: | Circulating Cancer Associated Fibroblasts (CCAF) levels evaluated from peripheral blood samples. |
Details
Phase: | N/A |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | University of Miami |
Last Updated
March 8, 2021