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

NCT ID: NCT01813097

Last Updated: 2013-03-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-02-29

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 rout, ECG and testosterone.

Two groups:

First group:30 cases should be treated with iodine 125 seed implants 0.5 mc transperineal prostate implant +Zoladex 3.6mg im 1/28d (LHRH agonist, 3.6mg subcutaneous injection 1/4weeks).

Second group: 30 cases should be treated with Zoladex 3.6mg im 1/28d (LHRH agonist, 3.6mg subcutaneous injection 1/4weeks).

PFS and PSA level will be the primary variables.

Conditions

Prostate Cancer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

combination iodine 125 seed implants

30 cases should be treated with iodine 125 seed implants 0.5 mc transperineal prostate implant +Zoladex 3.6mg im 1/28d (LHRH agonist, 3.6mg subcutaneous injection 1/4weeks).

No interventions assigned to this group

LHRH agonists

30 cases should be treated with Zoladex 3.6mg im 1/28d (LHRH agonist, 3.6mg subcutaneous injection 1/4weeks).

No interventions assigned to this group

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese PLA General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xu Yong

director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

D8664C00011

Identifier Type: -

Identifier Source: org_study_id