View Clinical Trial (Medical Research Study)
A Pilot Study of Image Guided Prostate and Pelvic Nodal Irradiation With Intensity Modulated Radiation Therapy (IMRT) in 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: Radiation therapy uses high-energy x-rays to kill tumor cells. Imaging
procedures, such as MRI, may help the doctor send x-rays directly to the tumor and nearby
lymph nodes and cause less damage to normal tissue.
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:
- Determine the feasibility of treating the pelvic lymph nodes in patients with prostate
cancer treated with intensity-modulated radiotherapy (IMRT).
- Determine the maximum tolerated dose of IMRT in these patients.
- Determine long term effects and toxicity in patients treated with IMRT.
OUTLINE: This is a pilot, dose-escalation study.
After pathology is available and 2 months of neoadjuvant hormone therapy is complete,
patients undergo MRI-guided intensity-modulated radiotherapy (IMRT) to the at-risk or
positive lymph nodes 5 days a week for 8.5 weeks.
Cohorts of 3-6 patients receive escalating doses of IMRT 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.
After completion of study treatment, patients are followed periodically for 3 years.
PROJECTED ACCRUAL: A total of 88 patients will be accrued for this study.
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| Criteria: |
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DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the prostate
- Risk of lymph node metastasis ≥ 10% OR biopsy-proven positive lymph nodes
- No metastatic disease beyond the pelvis
- Tumor visible on MRI
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- No bleeding disorders
- PT and PTT < 1.5 times upper limit of normal
- Platelet count > 50,000/mm^3
- No artificial heart valve
- Weight ≤ 136 kg
- No allergy to magnetic resonance contrast agent
- No pacemakers, cerebral aneurysm clips, shrapnel injury, or implantable electronic
devices
- No pre-existing or active prostatitis or proctitis
- No medical conditions, based on the opinion of the principal investigator, that would
preclude study treatment
- No cognitively impaired patients who cannot give informed consent
PRIOR CONCURRENT THERAPY:
- No prior surgery, radiotherapy, or chemotherapy for this cancer except for
neoadjuvant hormone therapy for up to 4 months
- Must receive neoadjuvant, concurrent, and adjuvant hormone therapy
- Must receive a nonsteroidal anti-androgen, such as flutamide, for approximately
6-8 weeks prior to starting radiotherapy
- Must receive a gonadotropin releasing-hormone agonist for concurrent and
adjuvant therapy
- Adjuvant therapy continues for 3 years or indefinitely
- No other concurrent surgery except standard biopsy
- No concurrent cytotoxic chemotherapy
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| NCT ID: |
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NCT00278356 |
| 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 21, 2013 |
| Modifications to this listing: |
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