Intensity-Modulated External Beam Radiation Therapy in Treating Patients With Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT01117935|
Recruitment Status : Active, not recruiting
First Posted : May 6, 2010
Last Update Posted : September 15, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|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||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study of Hypofractionated Intensity Modulated External Beam Therapy for the Treatment of Patients With Adenocarcinoma of the Prostate|
|Study Start Date :||May 30, 2010|
|Actual Primary Completion Date :||June 25, 2015|
|Estimated Study Completion Date :||May 31, 2018|
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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|