N/A N=60 Treatment

Stereotactic Body Radiotherapy (SBRT) for Prostate Cancer

Prostate Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00941915 ↗

Enrolled (actual)

Serious AEs

1.7%

Results posted

Jan 2022

Primary outcome: Primary: Number of Participants With Genitourinary Acute Toxicity — 44; 15; 0; 0 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: SBRT Prostate (Radiation)
Age: Adult, Older Adult · 40+ yrs
Sex: Male
Sponsor: Duke University
Primary completion: Feb 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Genitourinary Acute Toxicity	44; 15; 0; 0; 0	—
PRIMARY Number of Participants With Genitourinary Late Toxicity	22; 4; 0; 0; 0	—
PRIMARY Number of Participants With Gastrointestinal Acute Toxicity	19; 3; 0; 0; 0	—
PRIMARY Number of Participants With Gastrointestinal Late Toxicity	15; 5; 1; 0; 0	—
SECONDARY Disease Free Survival	—	—
SECONDARY Quality of Life, as Measured by the Expanded Prostate Cancer Index Composite (EPIC-26) Short Form	94.1; 77.7; 90.2; 94.4	—

Summary

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.

Eligibility Criteria

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00941915). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.