Status:

COMPLETED

Combination Iodine 125 Seed Implants and LHRH Agonists for Locally Advanced (Stage T3) Prostate Cancer

Lead Sponsor:

Chinese PLA General Hospital

Conditions:

Prostate Cancer

Eligibility:

All Genders

Brief Summary

Patients with prostate cancer should have the following examination including biopsy, serum PSA volume, prostate CT scan or MRI, bone scan, abdomen ultrasound, chest X ray, blood biochemistry, blood r...

Eligibility Criteria

Inclusion

  • Provision of written informed consent
  • T2c-T3b N0 M0 (biopsy、 bone scan、 CT、 MRI)
  • No Metastasis (bone scan、 CT、 MRI)
  • PSA level\>10ng/ml
  • Histological or cytological confirmation of prostate cancer
  • Able to understand and comply with the requirements of the study

Exclusion

  • Having been treated with external radiation therapy or chemistry therapy.
  • Clinical relevant disease and/or abnormalities (past or present), eg, significant cardiovascular, renal or liver disease, malignancy, gastro-intestinal disorders, or other conditions which could affect the absorption/elimination of drugs.
  • Alanine amino transferase (ALT) or aspartate amino transferase (AST) greater than 2 times the upper limit of normal (ULN) at screening findings that make it undesirable for the patient to participate in the study in the opinion of the investigator(s)
  • In the opinion of the investigator(s), any evidence of severe or uncontrolled systemic disease (eg, currently unstable or unresolved respiratory, cardiac, hepatic, or renal disease).
  • Contra-indications (eg, known or suspected allergy) to GnRH antagonists or excipients(non-active ingredients of investigational product).
  • Treatment with a non-approved or investigational drug within 30 days before study entry.
  • Bibulosity or drug abuse.

Key Trial Info

Start Date :

February 1 2008

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT01813097

Start Date

February 1 2008

Last Update

March 18 2013

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