A Phase II Randomized Trial of MRI-Guided Prostate Boosts Via Initial Lattice Stereotactic vs Daily Moderately Hypofractionated Radiotherapy - The Miami BLaStM Trial
Overview
- Phase
- N/A
- Intervention
- LEAD RT
- Conditions
- Prostate Cancer
- Sponsor
- University of Miami
- Enrollment
- 164
- Locations
- 1
- Primary Endpoint
- Rate of Early Prostate Tumor Response (EPTR)
- Status
- Active, Not Recruiting
- Last Updated
- 2 months ago
Overview
Brief Summary
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.
Investigators
Alan Pollack, MD, PhD
Professor
University of Miami
Eligibility Criteria
Inclusion 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-
- •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.
Exclusion Criteria
- Not provided
Arms & Interventions
LEAD RT Group
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.
Intervention: LEAD RT
HEIGHT RT Group
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.
Intervention: HEIGHT RT
Outcomes
Primary Outcomes
Rate of Early Prostate Tumor Response (EPTR)
Time Frame: Up to 3 years
Prostate Tumor Pathologic Complete Response (PathCR measured using ultrasound guided systematic prostate biopsy) and/or early biochemical response at 9 months post-RT.
Secondary Outcomes
- Correlation between EPTR and Changes in serial post-RT MRIs(3 months post-RT, 9-months post-RT, within 3 months of 2-2.5 post-treatment biopsy)
- Number of participants experiencing treatment related adverse events(Up to 2 years)
- Health-Related Quality of Life Scores: EPIC SF-12(Up to 5.25 years (post-treatment))
- Health-Related Quality of Life Scores: MAX-PC(Up to 5.25 years (post-treatment))
- Health-Related Quality of Life Scores: IPSS(Up to 5.25 years (post-treatment))
- Change in CTC Levels(Baseline (pre-treatment), Up to 2 years (post-treatment))
- Change in gene/biomarker expression(Baseline, Up to 5.25 years (post-treatment))
- Rate of participant response(Up to 5.25 years (post-treatment))