Intensity-Modulated External Beam Radiation Therapy in Treating Patients With Prostate Cancer
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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.
| Condition | Intervention |
|---|---|
|
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 Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: 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 ] [ Designated as safety issue: Yes ]
- Biochemical failure as defined by the Phoenix definition [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 55 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | May 2016 |
| Estimated Primary Completion Date: | May 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Other Names:
|
Detailed Description:
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.
Eligibility| Genders Eligible for Study: | 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
Contacts and Locations| Contact: Michael G. Chang, MD | 804-828-7232 | mchang@mcvh-vcu.edu |
| Contact: Diane J. Holdford, RN | 804-828-0296 | djholdfo@vcu.edu |
| United States, Virginia | |
| Virginia Commonwealth University | Recruiting |
| Richmond, Virginia, United States, 23298 | |
| Contact: Michael G. Chang, MD 804-828-7232 mgchang@vcu.edu | |
| Contact: Diane Holdford, RN 804-828-0296 djholdfo@vcu.edu | |
| Principal Investigator: Michael G. Chang | |
| Hunter Holmes McGuire Veterans Administration Medical Center | Recruiting |
| Richmond, Virginia, United States, 23249 | |
| Contact: Michael G. Chang, MD 804-828-7238 mchang@mcvh-vcu.edu | |
| Contact: Vicki Skinner, RN 804-675-5646 vskinner@vcu.edu | |
| Principal Investigator: Michael G. Chang, MD | |
| Principal Investigator: | Michael G. Chang, MD | Virginia Commonwealth University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Virginia Commonwealth University |
| ClinicalTrials.gov Identifier: | NCT01117935 History of Changes |
| Other Study ID Numbers: | MCC-12870, NCI-2010-00877 |
| Study First Received: | April 30, 2010 |
| Last Updated: | April 26, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Virginia Commonwealth University:
|
IMRT prostate cancer radiation therapy external beam recurrent prostate cancer |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Prostatic Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Neoplasms, Cystic, Mucinous, and Serous Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on June 18, 2013