Radiation Therapy in Treating Patients With Stage II or Stage III 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:	NCT00091390

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	Procedure: brachytherapy Procedure: radiation therapy	Phase II

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Phase II Trial Of Combined High Dose Rate Brachytherapy And External Beam Radiotherapy For Adenocarcinoma Of The Prostate

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

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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

Detailed Description:

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00091390

Locations

United States, California
Cancer Care Consultants Medical Associates at Daniel Freeman Memorial Hospital
Inglewood, California, United States, 90301
Providence Saint Joseph Medical Center - Burbank
Burbank, California, United States, 91505
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

Sponsors and Collaborators

Radiation Therapy Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

I-Chow J. Hsu, MD

UCSF Helen Diller Family Comprehensive Cancer Center

More Information

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

Publications of Results:

Jacob D, Raben A, Sarkar A, Grimm J, Simpson L. Anatomy-Based Inverse Planning Simulated Annealing Optimization in High-Dose-Rate Prostate Brachytherapy: Significant Dosimetric Advantage Over Other Optimization Techniques. Int J Radiat Oncol Biol Phys. 2008 May 1; [Epub ahead of print]

Study ID Numbers:	CDR0000382120, RTOG-0321
Study First Received:	September 7, 2004
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00091390
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

adenocarcinoma of the prostate
stage II prostate cancer
stage III 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 14, 2009