View Clinical Trial (Medical Research Study)
A Phase I Study of Image Guided Dose Escalation With Intensity Modulated Radiation Therapy (IMRT) to Histologically Confirmed Regions of Prostate Cancer
| City: |
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Bethesda |
| State: |
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Maryland |
| Zip Code: |
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20892 |
| Conditions: |
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Prostate Cancer |
| Purpose: |
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RATIONALE: Imaging procedures, such as MRI, may help the doctor find the exact location of
the tumor. Radiation therapy uses high-energy x-rays to kill tumor cells. This may be an
effective treatment for prostate cancer.
PURPOSE: This phase I trial is studying the side effects and best dose of MRI-guided
radiation therapy in treating patients with prostate cancer.
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| Study Summary: |
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OBJECTIVES:
Primary
- Determine the maximum tolerated dose of MRI-guided intensity-modulated external beam
radiotherapy in patients with prostate cancer.
Secondary
- Correlate the radiation response to and/or toxicity of this regimen with genomic and
proteomic analyses in these patients.
- Determine the long-term effects and toxicity of this regimen after selective
intra-prostatic dose escalation in these patients.
OUTLINE: This is a dose-escalation study.
Patients undergo MRI-guided intensity-modulated external beam radiotherapy over 10 minutes
once daily 5 days a week for 8.5 weeks.
Cohorts of 3-6 patients receive escalating doses of external beam radiotherapy (to areas of
histologically confirmed prostate cancer*) until the maximum tolerated dose (MTD) is
determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients
experience dose-limiting toxicity.
NOTE: *Areas of the prostate with signal abnormality on MRI that cannot be biopsied or
without definite histologic evidence of prostate cancer receive intermediate doses; all
other areas of the prostate receive standard doses.
After completion of study treatment, patients are followed at 2, 4, 8, and 12 weeks, 6, 9,
12, and 18 months, and then every 6 months for up to 5 years.
PROJECTED ACCRUAL: A total of 18-36 patients will be accrued for this study within 2 years.
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| Criteria: |
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DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the prostate
- Risk of lymph node metastasis < 10%
- Tumor visible on MRI
- No metastatic disease
PATIENT CHARACTERISTICS:
Age
- 18 to 89
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Platelet count > 50,000/mm^3
- No bleeding disorder
Hepatic
- PT/PTT < 1.5 times upper limit of normal
Renal
- Not specified
Cardiovascular
- No artificial heart valve
- No pacemaker
- No cerebral aneurysm clips
Other
- Weight ≤ 136 kg
- No allergy to magnetic resonance contrast agent
- No pre-existing or active prostatitis or proctitis
- No shrapnel injury or implantable electronic devices
- No other contraindication to biopsy or MRI
- No other medical condition that would preclude study participation
- No cognitive impairment that would preclude giving informed consent
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior chemotherapy for prostate cancer
Endocrine therapy
- Not specified
Radiotherapy
- No prior radiotherapy for prostate cancer
Surgery
- No prior surgery for prostate cancer
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| NCT ID: |
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NCT00227799 |
| Primary Contact: |
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Principal Investigator
Aradhana Kaushal, MD
National Cancer Institute (NCI)
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| Backup Contact: |
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N/A |
| Location Contact: |
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Bethesda, Maryland 20892
United States
Clinical Trials Office - Warren Grant Magnusen Clinical Center
Phone: 888-NCI-1937
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 19, 2013 |
| Modifications to this listing: |
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