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

Not Applicable

Completed

• Conditions: Adenocarcinoma of the Prostate; Stage II Prostate Cancer; Stage IV Prostate Cancer; Stage I Prostate Cancer; Stage III Prostate Cancer
• Interventions: Radiation: intensity modulated external beam radiation therapy

• Registration Number: NCT01117935
• Lead Sponsor: Virginia Commonwealth University

Brief Summary

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.

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.

Study Timeline

• Study First Submitted: 2010-04-30
• Study First Submitted QC: 2010-05-05
• Study First Posted: 2010-05-06
• Study Start: 2010-05-30
• Primary Completion: 2015-06-25
• Study Completion: 2019-03-01
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-27
• Last Update Posted: 2019-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm I	intensity modulated external beam radiation therapy	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.

Primary Outcome Measures

Name	Time	Method
Toxicity as measured by Common Terminology Criteria for Adverse Events (CTCAE) v3 criteria	At 2 years

Secondary Outcome Measures

Name	Time	Method
Biochemical failure as defined by the Phoenix definition	2 years

Trial Locations

Locations (2)

Hunter Holmes McGuire Veterans Administration Medical Center; 🇺🇸 Richmond, Virginia, United States

Virginia Commonwealth University/Massey Cancer Center; 🇺🇸 Richmond, Virginia, United States