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Comparison of Two Radiation Therapy Regimens in Treating Patients With Stage II or Stage III Prostate Cancer
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Purpose
RATIONALE: Radiation therapy uses high-energy x-rays and other sources of radiation to kill tumor cells. It is not yet known which radiation therapy regimen is more effective in treating prostate cancer.
PURPOSE: This randomized phase III trial is comparing two different regimens of radiation therapy to see how well they work in treating patients with stage II or stage III prostate cancer.
| Condition | Intervention | Phase |
|---|---|---|
| Prostate Cancer | Radiation: radiation therapy | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase III Intensity Modulated Radiotherapy Dose Escalation Trial for Prostate Cancer Using Hypofractionation |
- Freedom from biochemical and/or disease failure rates [ Time Frame: weekly during treatment, at 3 months, 6 months or 2 years then yearly ]
| Enrollment: | 307 |
| Study Start Date: | June 2002 |
| Primary Completion Date: | May 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: CIMRT
76 Gy in 38 fractions
|
Radiation: radiation therapy |
|
Experimental: HIMRT
70.2 Gy in 26 fractions
|
Radiation: radiation therapy |
Detailed Description:
OBJECTIVES:
- Compare the efficacy of conventional intensity-modulated radiotherapy (IMRT) vs hypofractionated IMRT, in terms of freedom from biochemical failure in men with intermediate- to high-risk prostate cancer.
- Compare the local control, freedom from distant metastasis, and overall survival of patients treated with these regimens.
- Determine local failure, using biopsy of the prostate, when objective tests (prostate-specific antigen, ultrasound, and digital rectal exam) suggest relapse in these patients.
- Compare the extent of disease eradication using biopsy of the prostate at 2 years after therapy in these patients.
- Compare the quality of life of patients treated with these regimens.
- Determine the impact of these regimens on patient preferences and utilities.
OUTLINE: This is a randomized study. Patients are stratified according to pretreatment prostate-specific antigen (no greater than 10 ng/mL vs greater than 10 to 20 ng/mL vs greater than 20 ng/mL), Gleason score (5-7 vs 8-10), and risk status (high risk vs intermediate risk). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo conventional intensity-modulated radiotherapy (IMRT) 5 days a week for 7.5 weeks in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients undergo hypofractionated IMRT 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity.
Patients with high-risk disease also undergo androgen deprivation therapy for 2 years.
Quality of life is assessed at baseline, every 6 months for 1 year, and then annually for 4 years.
Patients are followed at 3 months, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 300 patients (150 per treatment arm) will be accrued for this study within 3 years.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
-
Histologically confirmed adenocarcinoma of the prostate
- Clinical stage T1b-T3c disease
- No clinical or radiographic evidence of metastasis
- Prostate-specific antigen (PSA) less than 80 ng/mL
- Gleason score at least 5
-
One of the following criteria must be met:
- PSA greater than 10 ng/mL
- Gleason score greater than 6
- T2b or greater palpable disease
- Three or more biopsy cores involved with a Gleason score of at least 5
PATIENT CHARACTERISTICS:
Age
- Not specified
Performance status
- Zubrod 0-1
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Other
- No other medical condition that would preclude study participation
- No other active malignancy within the past 5 years except nonmetastatic skin cancer or early stage chronic lymphocytic leukemia (well-differentiated small cell lymphocytic leukemia)
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- No more than 4 months of prior androgen deprivation therapy
- Neoadjuvant and adjuvant androgen deprivation therapy is allowed for high-risk disease only
Radiotherapy
- No prior pelvic radiotherapy
Surgery
- No prior or planned radical prostate surgery
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00062309
| United States, Pennsylvania | |
| Fox Chase Cancer Center - Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19111-2497 | |
| Principal Investigator: | Mark Buyyounouski, MD | Fox Chase Cancer Center |
More Information
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Fox Chase Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00062309 History of Changes |
| Other Study ID Numbers: |
CDR0000304712 P30CA006927 ( US NIH Grant/Contract Award Number ) FCCC-02602 |
| Study First Received: | June 5, 2003 |
| Last Updated: | March 1, 2016 |
Keywords provided by Fox Chase Cancer Center:
|
stage II prostate cancer stage III prostate cancer adenocarcinoma of the prostate |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on June 28, 2017