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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

1116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2022-12-22

Brief Summary

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RATIONALE: Giving radiation therapy that uses a 3-dimensional (3-D) image of the tumor to help focus thin beams of radiation directly on the tumor, and giving hypofractionated radiation therapy (higher doses over a shorter period of time), may be less costly with fewer side effects and just as effective in treating prostate cancer.

PURPOSE: This randomized phase III trial is studying several different radiation therapy regimens to compare how well they work in treating patients with stage II prostate cancer.

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Detailed Description

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OBJECTIVES:

Primary

* Compare the disease-free survival (DFS) of patients with favorable-risk stage II prostate cancer treated with hypofractionated vs conventionally fractionated three-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated radiotherapy (IMRT).

Secondary

* Compare time to local progression, freedom from biochemical recurrence, and disease-specific and overall survival of patients treated with these regimens.
* Determine the incidence of gastrointestinal and genitourinary toxic effects in patients treated with these regimens.
* Compare the degree, duration, and significant differences in disease-specific health-related quality of life (HRQOL) decrements, using the Expanded Prostate Cancer Index Composite (EPIC), in patients treated with these regimens.
* Determine whether anxiety and/or depression, as measured by the Hopkins Symptom Checklist-25 (HSCL-25), are decreased with therapy that improves DFS of these patients .
* Determine whether the incremental gain in DFS outweighs decrements in the generic domains of HRQOL (i.e., mobility, self care, usual activities, pain/discomfort, and anxiety/depression) in patients treated with these regimens.
* Conduct a cost-utility analysis of hypofractionated 3D-CRT or IMRT as a prostate cancer therapy if this regimen is shown to be as effective as conventionally fractionated 3D-CRT or IMRT in improving DFS.

OUTLINE: This is a randomized, controlled, multicenter study. Patients are stratified according to Gleason score (2-4 vs 5-6), prostate-specific antigen (PSA) level (\< 4 ng/mL vs 4-\<9 ng/mL), and planned radiotherapy 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 conventionally fractionated 3D-CRT or IMRT once daily 5 days a week for 8.2 weeks (total of 41 treatments).
* Arm II: Patients undergo hypofractionated 3D-CRT or IMRT once daily 5 days a week for 5.6 weeks (total of 28 treatments).

Quality of life, anxiety, and depression are assessed at baseline and then at 6 months and 1, 2, and 5 years after the start of radiotherapy.

After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 1,067 patients will be accrued to this study.

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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Conventional 3D-CRT

Conventional 3D-CRT or IMRT to 73.8 Gy in 41 fractions

Group Type ACTIVE_COMPARATOR

Conventional 3D-CRT or IMRT

Intervention Type RADIATION

Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy

Hypofractionated 3D-CRT

Hypofractionated 3D-CRT or IMRT to 70 Gy in 28 fractions

Group Type EXPERIMENTAL

Hypofractionated 3D-CRT or IMRT

Intervention Type RADIATION

Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.

Interventions

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Conventional 3D-CRT or IMRT

Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy

Intervention Type RADIATION

Hypofractionated 3D-CRT or IMRT

Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.

Intervention Type RADIATION

Other Intervention Names

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3-dimensional conformal radiation therapy Intensity-modulated radiation therapy (IMRT) Hypofractionated 3-dimensional conformal radiation therapy Intensity-modulated radiation therapy (IMRT)

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Histologically confirmed adenocarcinoma of the prostate within the past 6 months

* Clinical stage T1-2c
* Combined Gleason score 2-6
* Prostate-specific antigen (PSA) \< 10 ng/mL within the past 6 months

* PSA evaluated at least 10 days after prostate biopsy
* For patients who received finasteride, PSA evaluated at least 30 after completion of finasteride
* For patients who received dutasteride, PSA evaluated at least 90 after completion of dutasteride
* No regional lymph node involvement
* No distant metastases

PATIENT CHARACTERISTICS:

* Zubrod performance status 0-1
* No unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
* No transmural myocardial infarction within the past 6 months
* No acute bacterial or fungal infection requiring IV antibiotics
* No chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study treatment
* No hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
* No known AIDS
* No prior or concurrent lymphomatous/hematogenous malignancy or other invasive malignancy except nonmelanomatous skin cancer or any other cancer for which the patient has been continually disease-free for ≥ 5 years (e.g., carcinoma in situ of the bladder or oral cavity)
* No other severe, active comorbidity

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior radical prostatectomy or cryosurgery for prostate cancer
* No prior hormonal therapy, including any of the following:

* Luteinizing hormone-releasing hormone agonists (e.g., goserelin or leuprolide)
* Antiandrogens (e.g., flutamide or bicalutamide)
* Estrogens \[e.g., diethylstilbestrol (DES)\]
* Surgical castration (bilateral orchiectomy)
* No prior pelvic radiotherapy or prostate brachytherapy
* No prior or concurrent cytotoxic chemotherapy for prostate cancer
* At least 30 days since prior finasteride
* At least 90 days since prior dutasteride
* No concurrent neoadjuvant or adjuvant hormonal therapy
* Concurrent warfarin or other blood-thinning agents allowed

Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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W. Robert Lee, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Duke Cancer Institute

Mahul B Amin, MD

Role: STUDY_CHAIR

Cedars-Sinai Medical Center

Deborah W Bruner, RN, PhD

Role: STUDY_CHAIR

University of Pennsylvania

Daniel Low, PhD

Role: STUDY_CHAIR

Washington University School of Medicine

Gregory P Swanson, MD

Role: STUDY_CHAIR

UTHSC San Antonio

Locations

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Arizona Oncology Services Foundation

Phoenix, Arizona, United States

Site Status

Arizona Oncology - Tucson

Tucson, Arizona, United States

Site Status

Auburn Radiation Oncology

Auburn, California, United States

Site Status

Alta Bates Summit Comprehensive Cancer Center

Berkeley, California, United States

Site Status

Providence Saint Joseph Medical Center - Burbank

Burbank, California, United States

Site Status

Peninsula Medical Center

Burlingame, California, United States

Site Status

Radiation Oncology Centers - Cameron Park

Cameron Park, California, United States

Site Status

Mercy Cancer Center at Mercy San Juan Medical Center

Carmichael, California, United States

Site Status

East Bay Radiation Oncology Center

Castro Valley, California, United States

Site Status

Valley Medical Oncology Consultants - Castro Valley

Castro Valley, California, United States

Site Status

Valley Medical Oncology

Fremont, California, United States

Site Status

Marin Cancer Institute at Marin General Hospital

Greenbrae, California, United States

Site Status

Sutter Health - Western Division Cancer Research Group

Greenbrae, California, United States

Site Status

Kaiser Permanente Medical Center - Hayward

Hayward, California, United States

Site Status

Veterans Affairs Medical Center - Long Beach

Long Beach, California, United States

Site Status