Prostate CancerNCT00375687
Investigation of Early Hormonotherapy Efficacy of Prostate Cancer
A study testing Triptorelin in people with Prostate Cancer, run by Kaunas University of Medicine at 1 site in Lithuania.
Trial summary
The purpose of this study is to determine whether early hormonotherapy is effective in the treatment of high risk prostate cancer patients after radical prostatectomy. Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Triptorelin
- How many people
- 61 participants
- Where
- 1 siteLithuania
- Study dates
- Aug 2005to Jan 2020
- Phase
- Interventional
- 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 40 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- preoperative PSA>20ng/ml
- postoperative PSA >0.2 ng/ml
- Gleason > 7
- pT3b
- signated infomed consent
Who cannot join
- neoadjuvant hormonaltherapy before RP
- R1 RP
- N+ RP
- unstable cncomitant conditions
Trial locations and contacts
1 site in 1 country.
Lithuania1 site, 1 recruiting
- Recruiting
Urology dep. of Kaunas University of Medicine
Kaunas, 50009
Mindaugas Jievaltas, MD, PhD, +37068730659, minjiev@Yahoo.com
Mindaugas Jievaltas, MD, PhD
About this study
Official title: Investigation of Early Hormonotherapy Efficacy of High Risk Patients for Progression of Prostate Cancer After Radical Prostatectomy
The purpose of this study is to determine whether early hormonotherapy is effective in the treatment of high risk prostate cancer patients after radical prostatectomy.
Read the detailed description
The primary purpose of this study is to evaluate the hypothesis, that early administration of adjuvant hormonotherapy (triptorelin) can prolong survival data for high risk patients. Control group (randomised study) will be treated with hormonotherapy, when PSA recidive appear (on demand treatment). Secondary purposes will be to compare PSA dinamics and quality of life data in the groups.
- Conditions
- Prostate Cancer
- Being tested
- Triptorelin
- Keywords
- 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.
TriptorelinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Secondary outcomes (2)
PSA dinamics
quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2006 (estimated)
- Study startAug 2005
- Study completionJan 2020
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants
Sponsor and investigators
- Lead sponsor
- Kaunas University of Medicine
- Sponsor type
- University, hospital or other
- Investigators
- Mindaugas Jievaltas, MD, PhD, Principal investigator, Urology dep. of Kaunas University of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00375687
- Sponsor's protocol ID
- KMU-Urol1
- Status last verified
- Nov 2005
- First submitted
- 12 Sep 2006
- Last updated
- 13 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Early Hormonotherapy Efficacy of High Risk Patients for Progression of Prostate Cancer After Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT00375687
- Acronym / sponsor ID
- KMU-Urol1
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 61 participants
- Lead sponsor
- Kaunas University of MedicineUniversity, hospital or other
- Study start
- Aug 2005
- Study completion
- Jan 2020
- First posted
- 13 Sep 2006 (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.
The purpose of this study is to determine whether early hormonotherapy is effective in the treatment of high risk prostate cancer patients after radical prostatectomy.
Detailed description
The primary purpose of this study is to evaluate the hypothesis, that early administration of adjuvant hormonotherapy (triptorelin) can prolong survival data for high risk patients. Control group (randomised study) will be treated with hormonotherapy, when PSA recidive appear (on demand treatment). Secondary purposes will be to compare PSA dinamics and quality of life data in the groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- preoperative PSA>20ng/ml
- postoperative PSA >0.2 ng/ml
- Gleason > 7
- pT3b
- signated infomed consent
Key exclusion criteria (4 listed)
- neoadjuvant hormonaltherapy before RP
- R1 RP
- N+ RP
- unstable cncomitant conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triptorelin | Drug | – |
Primary outcome
Survival
2 secondary outcomes
PSA dinamics
quality of life
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2006.
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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.
Mindaugas Jievaltas, MD, PhD principal investigator
Urology dep. of Kaunas University of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triptorelin in people with Prostate Cancer, run by Kaunas University of Medicine at 1 site in Lithuania.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 13 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mindaugas Jievaltas, PhD (+37068730659, minjiev@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival. 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 13 Sep 2006.