Radiation Therapy in Treating Patients With Stage II or Stage III Prostate Cancer
Recruitment status was Active, not recruiting
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Purpose
RATIONALE: Radiation therapy uses high-energy x-rays and other sources to damage tumor cells. Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving internal radiation therapy together with external-beam radiation therapy works in treating patients with stage II or stage III prostate cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Radiation: brachytherapy Radiation: radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Trial Of Combined High Dose Rate Brachytherapy And External Beam Radiotherapy For Adenocarcinoma Of The Prostate |
- Late severe genitourinary (GU) and gastrointestinal (GI) toxicity as measured by CTCAE v3.0 more than 9 months after starting treatment [ Designated as safety issue: Yes ]
- Acute severe GU and GI toxicity as measured by CTCAE v3.0 within 9 months of starting treatment [ Designated as safety issue: Yes ]
- Biochemical failure [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Disease-specific survival [ Designated as safety issue: No ]
- Clinical progression including local/regional and distant relapse [ Designated as safety issue: No ]
| Estimated Enrollment: | 110 |
| Study Start Date: | July 2004 |
OBJECTIVES:
Primary
- Determine the rate of late grade 3 or greater genitourinary and gastrointestinal toxicity after treatment with external beam radiotherapy and high-dose rate brachytherapy in patients with stage II or III adenocarcinoma of the prostate.
Secondary
- Determine acute grade 3 or greater genitourinary and gastrointestinal toxicity in patients treated with this regimen.
- Determine freedom from biochemical failure in patients treated with this regimen.
- Determine overall survival of patients treated with this regimen.
- Determine disease-specific survival of patients treated with this regimen.
- Determine clinical relapse (local and/or distant) in patients treated with this regimen.
- Develop a quality assurance process for high-dose rate prostate brachytherapy.
OUTLINE: This is a multicenter study. Patients are stratified according to prostate-specific antigen (≤ 10 ng/mL vs 11-20 ng/mL), T stage (T1c-T2c vs T3a-T3b), combined Gleason score (2-6 vs 7 vs 8-10), prior hormonal therapy (no vs yes), and timing of high-dose rate brachytherapy (before external beam radiotherapy vs after external beam radiotherapy).
Patients undergo external beam radiotherapy over approximately 15 minutes once daily 5 days a week for 5 weeks. Patients also receive two fractions (within a 24-hour period) of high-dose rate brachytherapy (delivered through an implant inserted into the prostate) over approximately 5-30 minutes either before or after external beam radiotherapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed at 3, 7, 9, and 12 months, every 6 months for 5 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 110 patients will be accrued for this study within 1 year.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate
- Clinical stage T1c-T3b
- No clinically or pathologically involved lymph nodes (N0 by pelvic CT scan or MRI)
- No distant metastases (M0 by negative bone scan)
Meets one of the following combination criteria:
- Clinical stage T1c-T2c, Gleason score 2-6, and prostate-specific antigen (PSA) > 10 but ≤ 20 ng/mL
- Clinical stage T3a-T3b, Gleason score 2-6, and PSA ≤ 20 ng/mL
- Clinical stage T1c-T3b, Gleason score 7-10, and PSA ≤ 20 ng/mL
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Zubrod 0-1
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Other
- Fertile patients must use effective contraception
- No hip prosthesis
- No major medical or psychiatric illness that would preclude study participation
- No prior invasive malignancy except nonmelanomatous skin cancer (e.g., carcinoma in situ of the oral cavity or bladder) or any other malignancy with a disease-free status ≥ 3 years
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior chemotherapy for prostate cancer
Endocrine therapy
- Prior induction hormonal therapy allowed provided therapy was initiated within 90 days before study enrollment
Radiotherapy
- No prior pelvic or prostate radiotherapy
- No concurrent intensity-modulated radiotherapy
Surgery
- No prior radical surgery for prostate cancer
- No prior transurethral resection of the prostate
Contacts and Locations| United States, California | |
| Providence Saint Joseph Medical Center - Burbank | |
| Burbank, California, United States, 91505 | |
| Cancer Care Consultants Medical Associates at Daniel Freeman Memorial Hospital | |
| Inglewood, California, United States, 90301 | |
| Radiological Associates of Sacramento Medical Group, Incorporated | |
| Sacramento, California, United States, 95815 | |
| United States, Colorado | |
| University of Colorado Cancer Center at University of Colorado Health Sciences Center | |
| Aurora, Colorado, United States, 80045 | |
| United States, Florida | |
| Lynn Regional Cancer Center at Boca Raton Community Hospital - Main Center | |
| Boca Raton, Florida, United States, 33486 | |
| United States, Illinois | |
| OSF St. Francis Medical Center | |
| Peoria, Illinois, United States, 61637 | |
| United States, Maine | |
| Maine Center for Cancer Medicine and Blood Disorders - Scarborough | |
| Scarborough, Maine, United States, 04074 | |
| United States, Michigan | |
| William Beaumont Hospital - Royal Oak Campus | |
| Royal Oak, Michigan, United States, 48073 | |
| United States, New Jersey | |
| Newark Beth Israel Medical Center | |
| Newark, New Jersey, United States, 07112 | |
| United States, New York | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
| United States, Vermont | |
| Fletcher Allen Health Care - University Health Center Campus | |
| Burlington, Vermont, United States, 05401 | |
| United States, Wisconsin | |
| Waukesha Memorial Hospital Regional Cancer Center | |
| Waukesha, Wisconsin, United States, 53188 | |
| Study Chair: | I-Chow J. Hsu, MD | University of California, San Francisco |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00091390 History of Changes |
| Other Study ID Numbers: | CDR0000382120, RTOG-0321 |
| Study First Received: | September 7, 2004 |
| Last Updated: | February 18, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
adenocarcinoma of the prostate stage IIB prostate cancer stage IIA prostate cancer stage III prostate cancer |
Additional relevant MeSH terms:
|
Adenocarcinoma Prostatic Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013