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Radiation Therapy in Treating...

Radiation Therapy in Treating Patients With Stage II Prostate Cancer

Last Updated: 2023-01-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1534 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-03-31

Study Completion Date

2022-12-22

Brief Summary

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RATIONALE: Specialized 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. It is not yet known which dose of radiation therapy is more effective in treating stage II prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two different doses of specialized radiation therapy in treating patients who have stage II prostate cancer.

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Detailed Description

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OBJECTIVES:

* Compare the overall survival of patients with stage II adenocarcinoma of the prostate treated with high- vs standard-dose three-dimensional conformal or intensity-modulated radiotherapy.
* Compare the freedom from prostate-specific antigen failure, disease-specific survival, local progression, and distant metastases in patients treated with these regimens.
* Compare the probability of tumor control and normal tissue complications in patients treated with these regimens.
* Compare the incidence of grade 2 or greater genitourinary and gastrointestinal acute and late toxicity in patients treated with these regimens.
* Compare the quality of life, including sexual function, of patients treated with these regimens.
* Correlate histopathologic or tumor-specific cytogenetic or chromosomal markers with cancer control outcomes in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to Gleason score and prostate-specific antigen (PSA) level (Gleason score 2-6, PSA ≥10 mg/mL but \< 20 ng/mL vs Gleason score 7, PSA \< 15 ng/mL) and radiation modality (three-dimensional conformal radiotherapy \[3D-CRT\] vs intensity-modulated radiotherapy \[IMRT\]). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients undergo standard-dose 3D-CRT or IMRT once daily, 5 days a week, for 7.8 weeks (39 treatment days).
* Arm II: Patients undergo high-dose 3D-CRT or IMRT once daily, 5 days a week, for 8.8 weeks (44 treatment days).

Quality of life (QOL) is assessed initially at baseline. After completion of radiotherapy, QOL is assessed every 3 months for 1 year and then every 6 months for 4 years.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 1,520 patients (760 per treatment arm) will be accrued for this study within 5 years.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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70.2 Gy

70.2 Gy 3D-CRT/IMRT

Group Type ACTIVE_COMPARATOR

70.2 Gy 3D-CRT/IMRT

Intervention Type RADIATION

Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 Fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.

79.2 Gy

79.2 Gy 3D-CRT/IMRT

Group Type EXPERIMENTAL

79.2 Gy 3D-CRT/IMRT

Intervention Type RADIATION

Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.

Interventions

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70.2 Gy 3D-CRT/IMRT

Intervention Type RADIATION

79.2 Gy 3D-CRT/IMRT

Intervention Type RADIATION

Other Intervention Names

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3D conformal radiation therapy intensity modulated radiation therapy 3D conformal radiation therapy intensity modulated radiation therapy

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Histologically confirmed adenocarcinoma of the prostate

* Clinical stage T1b-T2b
* Meets one of the following criteria:

* Gleason score 2-6 AND prostate-specific antigen (PSA) ≥ 10 ng/mL but \< 20 ng/mL
* Gleason score 7 AND PSA \< 15 ng/mL
* No regional lymph node involvement
* No distant metastases

PATIENT CHARACTERISTICS:

Age:

* Any age

Performance status:

* Zubrod 0-1

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* No other invasive malignancy within the past 5 years except localized basal cell or squamous cell skin cancer
* No other major medical or psychiatric illness that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* No prior cytotoxic chemotherapy
* No concurrent cytotoxic chemotherapy

Endocrine therapy:

* At least 3 months since prior finasteride
* No other prior hormonal therapy, including:

* Luteinizing hormone-releasing hormone agonists (e.g., goserelin or leuprolide)
* Antiandrogens (e.g., flutamide or bicalutamide)
* Estrogens (e.g., diethylstilbestrol)
* No concurrent (neoadjuvant or adjuvant) hormonal therapy

Radiotherapy:

* No prior pelvic irradiation or brachytherapy

Surgery:

* No prior radical surgery (prostatectomy) or cryosurgery for prostate cancer
* No prior surgical castration (bilateral orchiectomy)

Other:

* At least 3 months since prior finasteride or phytoestrogen preparation (PC-SPES)

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeff M. Michalski, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University - Saint Louis

James Purdy, Ph.D.

Role: STUDY_CHAIR

UC Davis

Deborah W Bruner, Ph.D.

Role: STUDY_CHAIR

Emory University

Mahul Amin, M.D.

Role: STUDY_CHAIR

Cedars-Sinai

Locations

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Veterans Affairs Medical Center - Long Beach

Long Beach, California, United States

Site Status

Radiological Associates of Sacramento Medical Group, Incorporated

Sacramento, California, United States

Site Status

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

Site Status

Washington Cancer Institute at Washington Hospital Center

Washington D.C., District of Columbia, United States

Site Status

Bay Medical

Panama City, Florida, United States

Site Status

Methodist Medical Center of Illinois

Peoria, Illinois, United States

Site Status

Oncology Center at Saint Margaret Mercy Healthcare Center

Hammond, Indiana, United States

Site Status

Cancer Center at Ball Memorial Hospital

Muncie, Indiana, United States

Site Status

Providence Medical Center

Kansas City, Kansas, United States

Site Status

Lawrence Memorial Hospital

Lawrence, Kansas, United States

Site Status

Menorah Medical Center

Overland Park, Kansas, United States

Site Status

Johnson County Radiation Therapy

Overland Park, Kansas, United States

Site Status

Shawnee Mission Medical Center

Shawnee Mission, Kansas, United States

Site Status

Lucille P. Markey Cancer Center at University of Kentucky

Lexington, Kentucky, United States

Site Status

Greenebaum Cancer Center at University of Maryland Medical Center

Baltimore, Maryland, United States

Site Status

Central Maryland Oncology Center

Columbia, Maryland, United States

Site Status

Veterans Affairs Medical Center - Ann Arbor

Ann Arbor, Michigan, United States

Site Status

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Site Status

Foote Memorial Hospital

Jackson, Michigan, United States

Site Status

West Michigan Cancer Center

Kalamazoo, Michigan, United States

Site Status

Breslin Cancer Center at Ingham Regional Medical Center

Lansing, Michigan, United States

Site Status

William Beaumont Hospital - Royal Oak Campus

Royal Oak, Michigan, United States

Site Status

CentraCare Clinic - River Campus

Saint Cloud, Minnesota, United States

Site Status

Regional Cancer Center at Singing River Hospital

Pascagoula, Mississippi, United States

Site Status