Prostate CancerNCT01813097
Combination Iodine 125 Seed Implants and LHRH Agonists for Locally Advanced (Stage T3) Prostate Cancer
An observational study of Prostate Cancer, run by Chinese PLA General Hospital.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Prostate Cancer
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Feb 2008to Mar 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subject number: <<60>>
Who may be able to join
- 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
Who cannot join
- 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.
About this study
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.
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
To detective the effect of the treatment of combination iodine 125 seed implants and LHRH agonists for the patients with locally advanced prostate cancer.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2013 (estimated)
- Study startFeb 2008
- Primary completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu Yong, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01813097
- Sponsor's protocol ID
- D8664C00011
- Status last verified
- Feb 2008
- First submitted
- 12 Mar 2013
- Last updated
- 18 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Iodine 125 Seed Implants and LHRH Agonists for Locally Advanced (Stage T3) Prostate Cancer
- ClinicalTrials.gov ID
- NCT01813097
- Acronym / sponsor ID
- D8664C00011
- 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.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Mar 2013 (actual)
- First posted
- 18 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subject number: <<60>>
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Chinese PLA General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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. (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2013.