Comparison of Between ThinSeed™ and OncoSeed™ for Permanent Prostate Brachytherapy

Status unconfirmed · Phase 4

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT01379742

Run by

Prostate Cancer Foundation of Chicago

People needed

240

Starts

2010-04-01

Last updated by the study team

2013-02-13

Who can join

Age: 40 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Chicago Prostate Center — Westmont, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

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