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CompletedNCT01813097Updated Mar 18, 2013

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

An observational study in Prostate Cancer, sponsored by Chinese PLA General Hospital. Completed. Per ClinicalTrials.gov, last updated 2013-03-18.

Sponsored by Chinese PLA General Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
60
Sex
All
01

Study 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.

02

Conditions studied

  • Prostate Cancer

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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.
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 60 is below the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Chinese PLA General Hospital is the lead sponsor of 558 studies on the registry; 202 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Subject number: \<\<60>>

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

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.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
60 participants (actual)
Patient registry
No

Groups and cohorts

  • 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).

06

What researchers measure

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.

    Time frame: two years

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01813097
Lead sponsor
Chinese PLA General Hospital
Responsible party
Xu Yong (director, Chinese PLA General Hospital) — Principal investigator
First posted
Mar 18, 2013
Start date
Feb 2008
Primary completion
Mar 2013
Last update
Mar 18, 2013

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2008. You cannot join it, but the record below documents what was studied.

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