Radiation Therapy in Treating Patients With Stage I, Stage II, or Stage III Prostate Cancer - Full Text View

Sponsored by:	Barbara Ann Karmanos Cancer Institute
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00258466

Purpose

RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells. It is not yet known which type of radiation therapy is more effective in treating prostate cancer.

PURPOSE: This randomized phase III trial is studying different types of radiation therapy to compare how well they work in treating patients with stage I, stage II, or stage III prostate cancer.

Condition	Intervention	Phase
Prostate Cancer	Procedure: radiation therapy	Phase III

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized
Official Title:	Phase III Trial of Neutron + Photon Radiation Versus Photon + Hypofractionated Intensity Modulated Radiation Therapy in Localized Prostate Cancer

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

Primary Outcome Measures:

Occurrence of chronic grade 2 or higher toxicity as measured by RTOG/EORTC late morbidity scoring scheme at 1, 4, 8, and 12 months after treatment, then every 6 months for 5 years, then annually [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Disease free survival at 1, 4, 8, and 12 months after treatment, then every 6 months for 5 years, then annually [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	May 2005

Detailed Description:

OBJECTIVES:

Compare the efficacy of neutron and photon radiotherapy vs hypofractionated intensity modulated radiation, in terms of a lower frequency of chronic complication rate (chronic toxicity and disease-free survival), in patients with favorable to intermediate prognosis, stage I-III adenocarcinoma of the prostate.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to stage of disease (T1 vs T2 vs T3). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients undergo neutron radiotherapy over 15-45 minutes 5 days a week for 2 weeks followed by photon radiotherapy over 15-45 minutes 5 days a week for 5 weeks.
Arm II: Patients undergo photon radiotherapy over 15-45 minutes 5 days a week for 5 weeks followed by hypofractionated photon irradiation over 15-45 minutes 5 days a week for 2 weeks.

After completion of study treatment, patients are followed periodically for 5 years and then yearly thereafter.

PROJECTED ACCRUAL: A total of 300 patients (150 per treatment arm) will be accrued for this study.

Eligibility

Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed adenocarcinoma of the prostate
- Stage I-III disease (T1-T3, N0, M0)
- No clinical or radiographic evidence of metastasis
  - If prostate-specific antigen (PSA) ≥ 10.0 ng/mL and Gleason score is 7, a radioisotope bone scan must show no evidence of metastasis
  - No evidence of lymphatic or visceral metastases of the abdomen or pelvis on CT scan or MRI
PSA ≤ 20 ng/mL
Gleason score ≤ 7 (if stage T3 , score must be < 7)

PATIENT CHARACTERISTICS:

Performance status

Not specified

Life expectancy

More than 10 years

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Not specified

Other

No other malignancy within the past 5 years except basal cell or squamous cell skin cancer

PRIOR CONCURRENT THERAPY:

Endocrine therapy

Prior hormonal therapy allowed provided it was initiated no more than 2 months ago, and may include the following:
- Luteinizing hormone-releasing hormone agonists (e.g., goserelin, leuprolide)
- Anti-androgens (e.g., flutamide, bicalutamide)

Radiotherapy

No prior pelvic irradiation

Surgery

No prior radical prostatectomy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00258466

Locations

United States, Michigan
Barbara Ann Karmanos Cancer Institute
Farmington Hills, Michigan, United States, 48334

Sponsors and Collaborators

Barbara Ann Karmanos Cancer Institute

Investigators

Study Chair:

Jeffrey D. Forman, MD, FACR

Weisberg Cancer Treatment Center

More Information

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

Study ID Numbers:	CDR0000447161, WSU-D-2879, WSU-HIC-047405MP4F
Study First Received:	November 23, 2005
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00258466
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

adenocarcinoma of the prostate
stage I prostate cancer
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