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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01117935
First received: April 30, 2010
Last updated: October 16, 2014
Last verified: October 2014
  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:


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: 55
Study Start Date: May 2010
Estimated Study Completion Date: August 2018
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:
  • 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

Ages Eligible for Study:   18 Years and older
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Virginia
Hunter Holmes McGuire Veterans Administration Medical Center
Richmond, Virginia, United States, 23249
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
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: October 16, 2014
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
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014