Intensity-Modulated External Beam Radiation Therapy in Treating Patients With Prostate Cancer - Full Text View

Sponsor:	Virginia Commonwealth University
Information provided by (Responsible Party):	Virginia Commonwealth University
ClinicalTrials.gov Identifier:	NCT01117935

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:

Toxicity as measured by Common Terminology Criteria for Adverse Events (CTCAE) v3 criteria [ Time Frame: At 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Biochemical failure as defined by the Phoenix definition [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	70
Study Start Date:	May 2010
Estimated Study Completion Date:	April 2012
Estimated Primary Completion Date:	April 2012 (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: EBRT IMRT

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:

EBRT
IMRT

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01117935

Contacts

Contact: Michael G. Chang, MD	804-828-7232	mchang@mcvh-vcu.edu
Contact: Diane J. Holdford, RN	804-828-0296	djholdfo@vcu.edu

Locations

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

Sponsors and Collaborators

Virginia Commonwealth University

Investigators

Principal Investigator:

Michael G. Chang, MD

Virginia Commonwealth University

More Information

Additional Information:

VCU Massey Cancer Center This link exits the ClinicalTrials.gov site

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:	January 13, 2012
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
Prostatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 24, 2012