Prostate Cancer
Conditions
Keywords
prostate cancer, prostate brachytherapy
Brief summary
This study will investigate health related quality of life factors in patients undergoing low dose rate prostate brachytherapy. Patients will be randomized to Iodine-125 Thinstrand (for use with 20 g needles) or Rapidstrand (for use with standard 18 g needles). Urinary, bowel, sexual function and bother will be measured by the EPIC questionnaire at various time intervals.
Interventions
DEVICERapidStrand seeds for use with 18g needle
Rapidstrand seeds are standard size and are used with 20 g needles
DEVICEThinStrand
ThinStrand seeds are smaller in diameter and used with 20g needles
Sponsors
Prostate Cancer Foundation of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed adenocarcinoma of the prostate, clinical stage T1c - T2b, N0, M0 * Greater than or equal to 40 years of age * Low and Low- Intermediate Risk prostate cancer * Prostate volumes by TRUS ≤ 60 cc * I-PSS score \< 25 (alpha blockers allowed) * Signed study-specific informed consent form prior to study entry
Exclusion criteria
* Lymph node involvement (N1) * Evidence of distant metastases (M1) * Radical surgery for carcinoma of the prostate * Prior pelvic radiation * Major medical or psychiatric illness, which in the investigator's opinion would prevent completion of treatment and would interfere with follow- up or ability to complete questionnaires * Hip prosthesis * Inability or refusal to provide informed consent * Evidence of Previous TURP * Prior hormone therapy * Prior TURP
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Health related quality of life including urinary, bowel and sexual function as measured by the EPIC questionnaire | 1 year | Randomized |
Countries
United States
Outcome results
None listed