Comparison of Between ThinSeed™ and OncoSeed™ for Permanent Prostate Brachytherapy
| Status: | Recruiting |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 40 - Any |
| Updated: | 4/2/2016 |
| Start Date: | April 2010 |
Comparison of Health Related Quality of Life and Other Clinical Parameters Between ThinSeed™ and OncoSeed™ for Permanent Low Dose Rate Implantation in Localized Prostate Cancer
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.
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.
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
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