|
Study ID
|
MCC-12870
|
|
Investigator
|
Michael G. Chang, MD, Virginia Commonwealth University
|
|
Title
|
Intensity-Modulated External Beam Radiation Therapy in Treating Patients With Prostate Cancer
|
|
Conditions
|
Adenocarcinoma of the Prostate
Stage I Prostate Cancer
Stage II Prostate Cancer
Stage III Prostate Cancer
Stage IV Prostate Cancer
|
|
Interventions
|
Radiation: intensity modulated external beam radiation therapy
|
|
Phase
|
N/A
|
|
Purpose
|
RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill
tumor cells. Specialized radiation therapy, such as intensity-modulated radiation therapy,
that delivers a high dose of radiation directly to the tumor may kill more tumor cells and
cause less damage to normal tissue.
PURPOSE: This clinical trial studies intensity-modulated external beam radiation therapy in
treating patients with prostate cancer.
|
|
Eligibility
|
Ages Eligible: N/A
Genders Eligible:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:- Patients with biopsy-proven adenocarcinoma of the prostate are eligible for protocol
enrollment when the following criteria are met; patients must have low, intermediate
or high-risk adenocarcinoma of the prostate, as defined by the National Comprehensive
Cancer Network (NCCN) criteria
- A diagnostic CT scan of the abdomen and pelvis will be obtained to rule out regional
disease (maximum of 60 days prior to registration) for high-risk patients only
- A bone scan showing no evidence of metastatic disease is also required for patients
whose prostate-specific antigen (PSA) is greater than 20 ng/ml, Gleason's sum is
greater than 7, or T-stage is greater than T2b
- Alkaline phosphatase within 1.5 x upper limit of normal (ULN) is required for all
patients beginning hormone therapy
- AST within 1.5 x ULN is required for all patients beginning hormone therapy
- Bilirubin within 1.5 x ULN is required for all patients beginning hormone therapy
- Karnofsky Performance score >= 80
- Prior to registration, patients having received no more than three months treatment
with anti-androgen, luteinizing hormone-releasing hormone (LHRH) agonist, or a
combination of the two remain eligible for protocol treatment; the qualifying PSA for
these patients will be the value recorded prior to the initiation of the hormone
therapy
Exclusion Criteria:- Patients with history of inflammatory bowel disease, or who require steroid or
cytotoxic therapy for collagen vascular disease
- Patients with a history of cancer other than skin cancer within five years of the
initiation of protocol treatment
- Patients with a history of pelvic irradiation for any reason
|
|
Study Location
|
N/A
|
|
Contact
|
Michael G. Chang, MD
804-828-7232
mchang@mcvh-vcu.edu
|
Information obtained from ClinicalTrials.gov, on
6/18/2013. For additional information about
this and other clinical trials,
visit http://clinicaltrials.gov.
Please refer to this study by its ClinicalTrials.gov identifier:
NCT01117935
|
|