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

Prostate Cancer Foundation of Chicago

Status and phase: Unknown; Phase 4

Conditions: Prostate Cancer

Treatments: Device: RapidStrand seeds for use with 18g needle; Device: ThinStrand

Study type: Interventional

Funder types: Other

Identifiers

NCT01379742

Thin-1

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: Male

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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240 participants in 2 patient groups

Iodine-125 standard 18 g needle

Active Comparator group

Description:

Rapidstrand

Treatment:

Device: ThinStrand

Device: RapidStrand seeds for use with 18g needle

20 g needle

Active Comparator group

Description:

Thin Strand

Treatment:

Device: ThinStrand

Device: RapidStrand seeds for use with 18g needle