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

Adenocarcinoma of the Prostate Clinical Trial

Official title:

Study of Hypofractionated Intensity Modulated External Beam Therapy for the Treatment of Patients With Adenocarcinoma of the Prostate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01117935
• Other study ID #: MCC-12870
• Secondary ID: NCI-2010-00877
• Status: Completed
• Phase: N/A
• Start date: May 30, 2010
• Est. completion date: March 1, 2019

Study information

• Verified date: June 2019
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: March 1, 2019
• Est. primary completion date: June 25, 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Prostate
• Prostatic Neoplasms
• Stage I Prostate Cancer
• Stage II Prostate Cancer
• Stage III Prostate Cancer
• Stage IV Prostate Cancer

Intervention

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

Locations

Country	Name	City	State
United States	Hunter Holmes McGuire Veterans Administration Medical Center	Richmond	Virginia
United States	Virginia Commonwealth University/Massey Cancer Center	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicity as measured by Common Terminology Criteria for Adverse Events (CTCAE) v3 criteria		At 2 years
Secondary	Biochemical failure as defined by the Phoenix definition		2 years

External Links

•   Abstract 2016 Genitourinary Cancers Symposium
•   VCU Massey Cancer Center