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Clinical study about the position verification using gold marker in the external irradiation combined I-125 brachytherapy for localized prostate cancer

Clinical study about the position verification using gold marker in the external irradiation combined I-125 brachytherapy for localized prostate cancer - Clinical study about the position verification using gold marker in the external irradiation combined I-125 brachytherapy for localized prostate cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000011078
Enrollment
40
Registered
2013-06-30
Start date
2013-07-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer

Interventions

Linear gold marker is buried in the connective tissue both side of the prostate at seed implantation. CT imaging is acquired just after seed implantation. One month after seed implantation, the planni

Sponsors

National Hospital Organization Saitama Hosipital
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1) Patients with intermediate/high risk group of localized prostate cancer to satisfy PSA>=10ng/ml or Gleason score>=7 or more than 34% positive biopsy core rate 2) Written informed consent must be obtained from patient

Exclusion criteria

Exclusion criteria: 1) Patients less than 5 years life expectancy 2) Patients with distant metastases 3) Patients with gold allergy 4) Patients whom radiation therapy is contraindicated 5) Patients with bleeding tendency (including anticoagulant therapy) 6) Patients with ascites, pleural effusion 7) Parients suspeted with skin, pleura, peritoneum infection 8) Parients suspeted with abscess, vascular disease 9) Patients who can not be ensured a safe puncture route 10) Patients who can not be transfused 11) Patients whom target site is confusing 12) Patients who are judged inappropriate for the clinical trial by doctors

Design outcomes

Primary

MeasureTime frame
The relative position error between the position coordinate and the reference CT image of the prostate as an index of the linear gold marker

Countries

Japan

Contacts

Public ContactTomoya Kaneda

National Hospital Organization Saitama Hosipital Radiology

tomoya_k54@yahoo.co.jp048-462-1101

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026