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

NCT ID: NCT01117935

Last Updated: 2019-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-30
• Study Completion Date: 2019-03-01

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.

Conditions

Adenocarcinoma of the Prostate; Stage I Prostate Cancer; Stage II Prostate Cancer; Stage III Prostate Cancer; Stage IV Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

intensity modulated external beam radiation therapy

Intervention Type: RADIATION

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

Interventions

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

Intervention Type: RADIATION

Other Intervention Names

EBRT; IMRT

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael G. Chang, MD

Role: PRINCIPAL_INVESTIGATOR

Massey Cancer Center

Locations

Hunter Holmes McGuire Veterans Administration Medical Center

Richmond, Virginia, United States

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, United States

Countries

United States

References

Ricco A, Mukhopadhyay N, Deng X, Holdford D, Skinner V, Saraiya S, Moghanaki D, Anscher MS, Chang MG. Moderately Hypofractionated Intensity Modulated Radiation Therapy With Simultaneous Integrated Boost for Prostate Cancer: Five-Year Toxicity Results From a Prospective Phase I/II Trial. Front Oncol. 2020 Aug 21;10:1686. doi: 10.3389/fonc.2020.01686. eCollection 2020.

Reference Type: DERIVED

PMID: 32974208 (View on PubMed)

Related Links

http://www.massey.vcu.edu/

VCU Massey Cancer Center

http://meetinglibrary.asco.org/record/119523/abstract

Abstract 2016 Genitourinary Cancers Symposium

Other Identifiers

NCI-2010-00877

Identifier Type: REGISTRY

Identifier Source: secondary_id

MCC-12870

Identifier Type: -

Identifier Source: org_study_id