Status:
TERMINATED
Phase I Study of Intensity Modulated Radiation Therapy for Prostate Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
18-90 years
Phase:
PHASE1
Brief Summary
BACKGROUND: -This study represents a progression from findings in four previous National Cancer Institute (NCI) Radiation Oncology Branch (ROB) protocols (02-C-0167A, 02-C-0207E, 03-C-0190B, 04-C-017...
Detailed Description
BACKGROUND: -This study represents a progression from findings in four previous National Cancer Institute (NCI) Radiation Oncology Branch (RO)B protocols (02-C-0167A, 02-C-0207E, 03-C-0190B, 04-C-017...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
- Pathology report confirming adenocarcinoma of the prostate
- Risk of lymph node metastasis less than 10% as defined by the Partin tables
- Tumor visible on magnetic resonance imaging (MRI)
- No prior surgery, radiation, or chemotherapy for prostate cancer.
- Age greater than 18 y/o and less than 90 years old.
- EXCLUSION CRITERIA:
- Cognitively impaired patients who cannot give informed consent.
- Patients with metastatic disease.
- Contraindication to biopsy
- Bleeding disorder
- Prothrombin time (PT)/Partial Thromboplastin Time (PTT) greater than or equal to 1.5 times the upper limit of normal
- Platelets less than or equal to 50K
- Artificial heart valve
- Contraindication to magnetic resonance imaging (MRI)
- Patients weighing greater than 136 kgs (weight limit for the scanner tables)
- Allergy to MR contrast agent
- Patients with pacemakers, cerebral aneurysm clips, shrapnel injury or implantable electronic devices.
- Pre-existing and active prostatitis or proctitis
- Other medical conditions deemed by the principal investigator (PI) or associates to make the patient ineligible for protocol investigations, procedures, and high-dose external beam radiotherapy.
Exclusion
Key Trial Info
Start Date :
July 21 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 9 2017
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00124917
Start Date
July 21 2005
End Date
May 9 2017
Last Update
September 13 2019
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892