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

Primary Purpose

Adenocarcinoma of the Prostate, Stage I Prostate Cancer, Stage II Prostate Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

intensity modulated external beam radiation therapy

About this trial

This is an interventional treatment trial for Adenocarcinoma of the Prostate focused on measuring IMRT, prostate cancer, radiation therapy, external beam, recurrent prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Hunter Holmes McGuire Veterans Administration Medical Center
Virginia Commonwealth University/Massey Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm I

Arm Description

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.

Outcomes

Primary Outcome Measures

Toxicity as measured by Common Terminology Criteria for Adverse Events (CTCAE) v3 criteria

Secondary Outcome Measures

Biochemical failure as defined by the Phoenix definition

Full Information

NCT ID

NCT01117935

First Posted

April 30, 2010

Last Updated

June 27, 2019

Sponsor

Virginia Commonwealth University

1. Study Identification

Unique Protocol Identification Number

NCT01117935

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Completed

Study Start Date

May 30, 2010 (undefined)

Primary Completion Date

June 25, 2015 (Actual)

Study Completion Date

March 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Virginia Commonwealth University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

IMRT, prostate cancer, radiation therapy, external beam, recurrent prostate cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

55 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm I

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

intensity modulated external beam radiation therapy

Other Intervention Name(s)

EBRT, IMRT

Intervention Description

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

Primary Outcome Measure Information:

Title

Toxicity as measured by Common Terminology Criteria for Adverse Events (CTCAE) v3 criteria

Time Frame

At 2 years

Secondary Outcome Measure Information:

Title

Biochemical failure as defined by the Phoenix definition

Time Frame

2 years

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael G. Chang, MD

Organizational Affiliation

Massey Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hunter Holmes McGuire Veterans Administration Medical Center

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23249

Country

United States

Facility Name

Virginia Commonwealth University/Massey Cancer Center

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23298

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

32974208

Citation

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.

Results Reference

derived

Links:

URL

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

Description

VCU Massey Cancer Center

URL

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

Description

Abstract 2016 Genitourinary Cancers Symposium

Learn more about this trial

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

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