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

Sponsor

Chinese PLA General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01813097

Collaborator

(none)

Enrollment

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer

Study Design

Study Type:

Observational

Actual Enrollment :

60 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Study Start Date :

Feb 1, 2008

Actual Primary Completion Date :

Mar 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Chinese PLA General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Xu Yong, director, Chinese PLA General Hospital

ClinicalTrials.gov Identifier:

NCT01813097

Other Study ID Numbers:

D8664C00011

First Posted:

Mar 18, 2013

Last Update Posted:

Mar 18, 2013

Last Verified:

Feb 1, 2008

Keywords provided by Xu Yong, director, Chinese PLA General Hospital

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

Additional relevant MeSH terms:

Prostatic Neoplasms

Study Results

No Results Posted as of Mar 18, 2013