Study of Hypofractionated Intensity Modulated External Beam Therapy for the Treatment of Patients With Adenocarcinoma of the Prostate
N/A
N/A
Male
Adenocarcinoma of the Prostate, Stage I Prostate Cancer, Stage II Prostate Cancer, Stage III Prostate Cancer, Stage IV Prostate Cancer
Trial Information
Study of Hypofractionated Intensity Modulated External Beam Therapy for the Treatment of Patients With Adenocarcinoma of the Prostate
PRIMARY OBJECTIVES:
I. To demonstrate that patients can safely receive IMRT teletherapy using the proposed IMRT
fractionation schedule without experiencing a treatment limiting toxicity.
SECONDARY OBJECTIVES:
I. To assess treatment efficacy through the surrogate measures of PSA nadir and biochemical
failure-free survival.
OUTLINE: Patients undergo hypofractionated intensity modulated radiotherapy once daily, 5
days a week, for 6 weeks in the absence of disease progression or unacceptable toxicity.
Patients with intermediate- and high-risk disease may also receive concurrent and adjuvant
or long-term androgen deprivation therapy for up to 36 months. After completion of study
treatment, patients are followed at 4-6 weeks, every 4 months for 3 years, every 6 months
for 2 years, and then annually until year 5.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Toxicity as measured by Common Terminology Criteria for Adverse Events (CTCAE) v3 criteria
Outcome Time Frame:
At 2 years
Safety Issue:
Yes
Principal Investigator
Michael G. Chang, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Virginia Commonwealth University
Authority:
United States: Institutional Review Board
Study ID:
MCC-12870
NCT ID:
NCT01117935
Start Date:
May 2010
Completion Date:
August 2018
Related Keywords:
- Adenocarcinoma of the Prostate
- Stage I Prostate Cancer
- Stage II Prostate Cancer
- Stage III Prostate Cancer
- Stage IV Prostate Cancer
- IMRT
- prostate cancer
- radiation therapy
- external beam
- recurrent prostate cancer
- Adenocarcinoma
- Adenocarcinoma, Mucinous
- Prostatic Neoplasms
Name | Location |
|---|---|
| Virginia Commonwealth University | Richmond, Virginia |
| Hunter Holmes McGuire Veterans Administration Medical Center | Richmond, Virginia 23249 |
