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Not Enrolling
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Prostate Cancer

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Trial Information


Inclusion Criteria:



1. Provision of written informed consent

2. T2c-T3b N0 M0 (biopsy、 bone scan、 CT、 MRI)

3. No Metastasis (bone scan、 CT、 MRI)

4. PSA level>10ng/ml

5. Histological or cytological confirmation of prostate cancer

6. Able to understand and comply with the requirements of the study

Exclusion Criteria:

1. Having been treated with external radiation therapy or chemistry therapy.

2. 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.

3. 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)

4. 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).

5. Contra-indications (eg, known or suspected allergy) to GnRH antagonists or
excipients(non-active ingredients of investigational product).

6. Treatment with a non-approved or investigational drug within 30 days before study
entry.

7. Bibulosity or drug abuse.

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

To detective the effect of the treatment of combination iodine 125 seed implants and LHRH agonists for the patients with locally advanced prostate cancer.

Outcome Time Frame:

two years

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

D8664C00011

NCT ID:

NCT01813097

Start Date:

February 2008

Completion Date:

Related Keywords:

  • Prostate Cancer
  • To detective the effect of the treatment of combination iodine 125 seed implants and LHRH agonists for the patients with locally advanced prostate cancer.
  • Prostatic Neoplasms

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