Radiation Therapy in Treating Patients With Stage II Prostate Cancer - Full Text View

Sponsors and Collaborators:	Radiation Therapy Oncology Group National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00331773

Purpose

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 kill more tumor cells and have fewer side effects. It is not yet known which radiation therapy regimen is more 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.

Condition	Intervention	Phase
Prostate Cancer	Procedure: 3-dimensional conformal radiation therapy Procedure: hypofractionated radiation therapy Procedure: intensity-modulated radiation therapy	Phase III

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	A Phase III Randomized Study of Hypofractionated 3D-CRT/MRT Versus Conventionally Fractionated 3D-CRT/MRT in Patients With Favorable-Risk Prostate Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Disease-free survival at 5 years as measured by Kaplan-Meier [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to failure [ Designated as safety issue: No ]
Disease-specific survival [ Designated as safety issue: No ]
Freedom from biochemical recurrence (FFBR) [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]
Incidence of GU and GI acute and late toxicity [ Designated as safety issue: Yes ]
Statistical modeling of genomic biomarkers [ Designated as safety issue: No ]
Comparison of disease-specific HRQOL change in EPIC; the Utilization of Sexual Medications/Devices supplements the EPIC [ Designated as safety issue: No ]
Assessment of anxiety and depression change using the HSCL-25 [ Designated as safety issue: No ]
Evaluation and comparison of the cost-utility of each treatment arm using EQ-5D if the primary endpoint supports the primary hypothesis [ Designated as safety issue: No ]
Collection of paraffin-embedded tissue block, serum, plasma, and buffy coat cells for future translational research analyses [ Designated as safety issue: No ]

Estimated Enrollment:	1067
Study Start Date:	April 2006
Estimated Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm I: Active Comparator Patients undergo conventionally fractionated 3D-CRT or IMRT once daily 5 days a week for 8.2 weeks (total of 41 treatments).	Procedure: 3-dimensional conformal radiation therapy 41 or 28 treatments Procedure: intensity-modulated radiation therapy 41 or 28 treatments
Arm II: Experimental Patients undergo hypofractionated 3D-CRT or IMRT once daily 5 days a week for 5.6 weeks (total of 28 treatments).	Procedure: 3-dimensional conformal radiation therapy 41 or 28 treatments Procedure: hypofractionated radiation therapy Once daily 5 days a week for 5.6 weeks Procedure: intensity-modulated radiation therapy 41 or 28 treatments

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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
- No PSA measurement for ≥ 10 days after prostate biopsy
- No PSA measurement for ≥ 30 days after discontinuation of finasteride (90 days after discontinuation 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00331773

Show 291 Study Locations

Sponsors and Collaborators

Radiation Therapy Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

W. Robert Lee, MD

Duke University

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Featured trial article This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000481119, RTOG-0415
Study First Received:	May 30, 2006
Last Updated:	January 14, 2009
ClinicalTrials.gov Identifier:	NCT00331773
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

adenocarcinoma of the prostate
stage II prostate cancer

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms

Genital Diseases, Male
Adenocarcinoma
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 15, 2009