This trial is active, not recruiting.

Condition prostate cancer
Treatment sbrt prostate
Phase phase 2
Sponsor Duke University
Start date November 2009
End date December 2017
Trial size 60 participants
Trial identifier NCT00941915, Pro00018266


The purpose of this study is to evaluate the incidence of urinary and gastrointestinal acute and late side effects in patients treated with stereotactic body radiotherapy (SBRT) to the prostate. Stereotactic radiation therapy is given as five treatments over a 2-3 week period. The prostate is localized and the plan is reoptimized as needed prior to each treatment.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Five fractions of 7.4 Gy each
sbrt prostate Stereotactic body radiation therapy
Five fractions of 7.4 Gy. The total dose will be 37 Gy. A minimum of 36 hours and a maximum of 96 hours should separate each treatment. No more than 3 fractions will be delivered per week. The total duration of treatment will be no shorter than 10 days and no longer than 18 days.

Primary Outcomes

time frame: 3 years

Secondary Outcomes

Disease free survival
time frame: 5 yrs
Quality of Life
time frame: 3 years

Eligibility Criteria

Male participants from 40 years up to 82 years old.

Inclusion Criteria: - Histologically confirmed diagnosis of adenocarcinoma of the prostate within 365 days of study enrollment - History/physical examination with digital rectal examination of the prostate within 8 weeks prior to study enrollment - Gleason score less than or equal to 7 - Clinical Stage T1-T2c - PSA - less than or = 15 ng/ml prior to start of therapy if Gleason < or = 6 or - less than or = 10 ng/ml prior to start of therapy if Gleason = 7 - Zubrod Performance Status 0-1 - Age > 40 Exclusion Criteria: - Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years. (Carcinoma in situ of the bladder or oral cavity is permissible) - Evidence of distant metastases - Regional lymph node involvement - Significant urinary obstruction - Estimated prostate gland > 100 grams - Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer - Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy - Previous hormonal therapy, such as LHRH agonists (e.g. goserelin, leuprolide), anti-androgens (e.g., flutamide, bicalutamide), estrogens (e.g., DES), or surgical castration (bilateral orchiectomy) or planned concurrent androgen deprivation therapy - Previous or concurrent cytotoxic chemotherapy for prostate cancer - Prosthetic implants in the pelvic region that contain metal or conductive materials (e.g., an artificial hip). - Severe, active comorbidity

Additional Information

Official title A Phase II Study of Stereotactic Body Radiotherapy (SBRT) for Prostate Cancer Using Continuous Real-time Evaluation of Prostate Motion and IMRT Plan Reoptimization Based on the Anatomy of the Day
Principal investigator William R Lee, MD
Description This protocol requires radiation treatments to be performed with a stereotactic technique with the use of a 3-D coordinate system defined by implanted transponders (i.e. Calypso) or use of the ExacTrac system and/or use cone-beam CT (CBCT) with fiducial markers.
Trial information was received from ClinicalTrials.gov and was last updated in January 2017.
Information provided to ClinicalTrials.gov by Duke University.