Intensity-Modulated External Beam Radiation Therapy in Treating Patients With Prostate Cancer
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.
|Adenocarcinoma of the Prostate Stage I Prostate Cancer Stage II Prostate Cancer Stage III Prostate Cancer Stage IV Prostate Cancer||Radiation: intensity modulated external beam radiation therapy|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Study of Hypofractionated Intensity Modulated External Beam Therapy for the Treatment of Patients With Adenocarcinoma of the Prostate|
- Toxicity as measured by Common Terminology Criteria for Adverse Events (CTCAE) v3 criteria [ Time Frame: At 2 years ]
- Biochemical failure as defined by the Phoenix definition [ Time Frame: 2 years ]
|Study Start Date:||May 30, 2010|
|Estimated Study Completion Date:||May 31, 2018|
|Primary Completion Date:||June 25, 2015 (Final data collection date for primary outcome measure)|
Experimental: Arm I
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.
Radiation: intensity modulated external beam radiation therapy
Low risk - 69.6 Gy in 2.4 Gy fractions to prostate
Intermediate risk - delivered in 30 fractions with neoadjuvant and concurrent androgen deprivation therapy: 72 Gy in 2.4 Gy fractions to prostate + 60 Gy in 2 Gy fractions to seminal vesicles +/- 50.4 Gy in 1.68 Gy fractions to lymph nodes
High risk - 30 fractions with neoadjuvant, concurrent, and long term adjuvant androgen deprivation therapy: 72 Gy in 2.4 Gy fractions to prostate + 60 Gy in 2 Gy fractions to seminal vesicles +/- 50.4 Gy at 1.68 Gy fractions to lymph nodes
I. To demonstrate that patients can safely receive IMRT teletherapy using the proposed IMRT fractionation schedule without experiencing a treatment limiting toxicity.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01117935
|United States, Virginia|
|Hunter Holmes McGuire Veterans Administration Medical Center|
|Richmond, Virginia, United States, 23249|
|Virginia Commonwealth University/Massey Cancer Center|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||Michael G. Chang, MD||Massey Cancer Center|