Know Cancer

or
forgot password

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


Phase 4
40 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

Health related quality of life including urinary, bowel and sexual function as measured by the EPIC questionnaire

Outcome Description:

Randomized

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Brian J Moran, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chicago Prostate Center

Authority:

United States: Institutional Review Board

Study ID:

Thin-1

NCT ID:

NCT01379742

Start Date:

April 2010

Completion Date:

Related Keywords:

  • Prostate Cancer
  • prostate cancer
  • prostate brachytherapy
  • Prostatic Neoplasms

Name

Location

Chicago Prostate CenterWestmont, Illinois  60559