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

NCT01813097 | Completed DMC

• 1 other identifier: D8664C00011
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

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

Keywords

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 Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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).

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subject number: \<\<60\>\>

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director

Study Record Dates

• First Submitted: March 12, 2013
• First Posted: March 18, 2013
• Study Start: February 1, 2008
• Primary Completion: March 1, 2013
• Last Updated: March 18, 2013

Record last verified: 2008-02