Stereotactic Body Radiotherapy (SBRT) for Prostate Cancer (SMART)

Duke University

Status

Completed

Conditions

Prostate Cancer

Treatments

Radiation: SBRT Prostate

Study type

Interventional

Funder types

Other

Identifiers

NCT00941915

Pro00018266

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

Male

Ages

40 to 82 years old

Volunteers

No Healthy Volunteers

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