View Clinical Trial (Medical Research Study)
A Phase III Randomized Trial of MRI-Mapped Dose-Escalated Salvage Radiotherapy Post-Prostatectomy: The MAPS Trial
| 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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1. The investigators hypothesize that increasing radiation dose to the functional
MRI-defined lesion in the prostate bed will result in an improved initial complete
response (reduction in PSA to < 0.1 ng/mL), which is related to long-term outcome
biochemically.
2. Biomarker expression levels differ in the DCE-MRI enhancing and non-enhancing tumor
regions.
3. 10-15% of men undergoing RT have free circulating DNA (fcDNA) or tumor cells (CTC) that
are related to an adverse treatment outcome.
4. Prostate cancer-related anxiety will be reduced in the MRI targeted SRT arm, because
the patients will be aware that the dominant tumor will be targeted with higher
radiation dose.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- Prostate cancer patients with a PSA after prostatectomy of at least 0.1 ng/mL and up
to 3.0 ng/mL within 8 weeks prior to enrollment.
- Patients with or without palpable abnormalities on digital rectal exam (DRE) are
eligible.
- Minimum of 3 months since prostatectomy to allow for return of urinary continence and
healing.
- MRI detectable lesion in prostate bed. DCE-MRI enhancing lesion in the prostate bed
should be at least 0.4 cc and a maximum of 6 cc and was obtained ≤ 8 weeks prior to
enrollment.
- No evidence of metastatic (regional or distant) disease on the pelvic MRI.
- Negative bone scan if deemed necessary by treating physician obtained ≤ 4 months
prior to enrollment.
- No previous pelvic radiotherapy.
- Prior androgen deprivation therapy is permitted as long as it was >6 months previous
to enrollment and was ≤7 months in duration.
- Serum total testosterone is within 40% of normal assay limits, taken within 4 months
prior to enrollment.
- BUN and creatinine is within 40% of normal assay limits, taken within 8 weeks prior
to enrollment.
- 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.
- Ability to understand and the willingness to sign a written informed consent
document.
- Zubrod performance status <2.
- Patients must agree to fill out quality of life/psychosocial questionnaires.
- Age ≥35 and ≤85 years.
Exclusion Criteria:
- Prostate cancer patients with a PSA after prostatectomy of less than 0.1 ng/mL or
greater than 3.0 ng/mL.
- Less than 3 months since prostatectomy.
- Unable to obtain a 3T MRI of the pelvis and prostate with contrast prior to
enrollment.
- No detectable MRI lesion in prostate bed.
- Patients with detectable DCE-MRI lesion which are less than 0.4 cc and greater than 6
cc
- Evidence of metastatic (regional or distant) disease on the pelvic MRI.
- Positive bone scan 4 months prior to enrollment.
- Previous pelvic radiotherapy.
- Prior androgen deprivation therapy is not permitted if it was within 6 months
previous to enrollment and/or was > 7 months in duration.
- Serum total testosterone is not within 40% of normal assay limits, taken within 4
months prior to enrollment.
- BUN and creatinine is not within 40% of normal assay limits, taken within 8 weeks
prior to enrollment.
- 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.
- Inability to understand and unwilling to sign a written informed consent document.
- Zubrod performance status ≥ 2.
- Not willing to fill out quality of life/psychosocial questionnaires.
- Age < 35 and > 85 years.
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| NCT ID: |
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NCT01411345 |
| Primary Contact: |
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Principal Investigator
Matthew C Abramowitz, MD
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
Matthew C Abramowitz, MD
Phone: 305-243-4200
Email: mabramowitz@med.miami.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
| Modifications to this listing: |
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