View Clinical Trial (Medical Research Study)
A Phase I Trial of MRI-Guided Lattice Extreme Ablative Dose Radiotherapy For Prostate Cancer
| City: |
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Miami |
| State: |
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Florida |
| Zip Code: |
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33136 |
| Conditions: |
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Prostate Cancer - Prostate Adenocarcinoma |
| Purpose: |
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The hypotheses of this study are:
1. Delivery of single fraction Lattice Extreme Ablative Dose (LEAD) radiotherapy (RT) to
the dominant tumor lesion(s) in the prostate as identified by Dynamic Contrast Enhanced
Magnetic Resonance Imaging (DCE-MRI) is safe and feasible.
2. Biomarker expression levels differ in the DCE-MRI enhancing and non-enhancing tumor
regions. The investigators hypothesize that a significant source of variation in
biomarker levels is due to tumor heterogeneity and that it is molecular abnormalities
in the dominant tumor areas that are angiogenic and determine outcome.
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| Study Summary: |
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The investigators propose to use a novel method for delivery of ablative spatially
fractionated radiation to the DCE-MRI defined tumor volume in the framework of a single-arm
phase I clinical trial. The technique, deemed Lattice Extreme Ablative Dose (LEAD) RT,
involves the creation of high doses shaped in cylinders through the DCE-MRI defined
region(s) and adjacent apparently normal prostate in a lattice framework. The LEAD RT
delivery will be in a single fraction of 12-14 Gy prior to standard fractions (2.0 Gy per
day) for an additional 76 Gy (total dose for all treatments of 88-90 Gy and 149 Gy3.0 in 2.0
Gy equivalents).
In this protocol the investigators also aim to examine biomarkers obtained from
ultrasound-guided biopsies. Emphasis will be placed on biopsying regions in which the
DCE-MRI shows enhancement. The DCE-MRI will be viewed on a separate monitor during the
ultrasound-guided biopsies to enhance the probability of obtained biomarkers more
representative of patient outcome. Biomarkers from biopsies from the index lesion(s) will be
compared to those from tumor in other areas of the prostate. Biopsy tissues will be
collected pre- and post-treatment and analyzed by immunohistochemistry (IHC) for biomarker
quantification.
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| Criteria: |
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Inclusion Criteria:
- Biopsy confirmed adenocarcinoma of the prostate.
- T1-T2 disease based on digital rectal exam.
- T3a disease based on MRI only is acceptable.
- Gleason score 6-8.
- Patients with Gleason score 8 must be offered long term androgen deprivation therapy
(ADT) and refuse such treatment because only 6 months (short term ADT) is permitted
on this protocol. All Gleason score 8 patients must receive 6 months of ADT. The ADT
should begin after fiducial marker placement.
- Gleason 8 must have <20% of the tissue involved with Gleason 8 in the biopsy
specimen.
- Patients with Gleason score ≤7 may be treated with 4-6 months of ADT. The ADT
should begin after fiducial marker placement.
- Prostate-specific antigen (PSA) ≤20 ng/mL within 8 weeks of enrollment.
- No previous pelvic radiotherapy.
- No previous history of radical/total prostatectomy (suprapubic prostatectomy is
acceptable).
- 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.
- Identifiable DCE-MRI tumor lesion or lesions, that total in volume <33% of the
prostate
- DCE-MRI of prostate and pelvis required prior to protocol consideration.
- Ability to understand and the willingness to sign a written informed consent
document.
- Zubrod performance status <2.
- Willingness to fill out quality of life forms.
- Bone scan negative if PSA >10 ng/mL or Gleason ≥7 disease. A questionable bone scan
is acceptable if plain x-rays and/or MRI are negative for metastasis.
- Serum testosterone is within 40% of normal assay limits and taken within 4 months of
enrollment.
- Serum liver function tests (LFT) are within 40% of normal assay limits and taken
within 8 weeks of enrollment.
- Complete blood counts are within 40% of normal assay limits, taken within 8 weeks of
enrollment.
- Age ≥35 and ≤85 years.
Exclusion Criteria:
- >T2 disease on digital rectal exam unless T3a disease is identified by MRI.
- Gleason score <6 and >8.
- ≥20% Gleason 8 tumor, over the total tissue including other tumor and normal tissue.
For example: (Gleason 8 tumor length/other biopsy tissue length)*100 = ≥20%.
- Patients are not eligible if they have been started on androgen deprivation therapy
prior to enrollment.
- Androgen deprivation therapy longer than 6 months. Androgen deprivation timing is for
the Luteinizing hormone-releasing hormone (LHRH) agonist portion only and not when
anti-androgen is started beforehand.
- PSA >20 ng/mL within 8 weeks of enrollment.
- Unable to obtain a 3T MRI of the pelvis and prostate with contrast prior to
randomization.
- Unidentifiable DCE-MRI tumor lesion.
- Identifiable DCE-MRI tumor lesions, that total in volume ≥33% of the prostate.
- Previous pelvic radiotherapy.
- Previous history of radical prostatectomy.
- 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.
- Zubrod performance status ≥ 2.
- Inability to understand or unwilling to sign a written informed consent document
- Unwilling to fill out quality of life/psychosocial forms.
- Bone scan is positive if PSA >10 ng/mL or Gleason ≥7 disease.
- Serum testosterone is not within 40% of normal assay limits taken within 4 months of
enrollment.
- Serum liver function tests (LFTs) are not within 40% of normal assay limits taken
within 8 weeks of enrollment.
- Complete blood counts are not within 40% of normal assay limits taken within 8 weeks
of enrollment.
- Age <35 and >85 years.
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| NCT ID: |
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NCT01411319 |
| Primary Contact: |
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Principal Investigator
Alan Pollack, MD. PhD
University of Miami Sylvester Comprehensive Cancer Center
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| Backup Contact: |
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N/A |
| Location Contact: |
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Miami, Florida 33136
United States
Alan Pollack, MD
Phone: 866-574-5124
Email: apollack@med.miami.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 25, 2013 |
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