Patients With T1-4 Advanced Prostate CancerPhase 4NCT00293670
FINNPROSTATE Study VII: Intermittent Versus Continuous Androgen Deprivation in Patients With Advanced Prostate Cancer
A Phase 4 study testing Goserelin (Zoladex) in people with Patients With T1-4 Advanced Prostate Cancer, run by Tampere University at 1 site in Finland.
Trial summary
To compare intermittent androgen deprivation (LHRHa treatment) with continuous androgen deprivation (LHRHa treatment or orchidectomy) Read more about this study
- Who is it for?
- Ages 0 years and older, men only
- Conditions the study is for
- Patients With T1-4 Advanced Prostate Cancer
- What is being tested?
- Goserelin (Zoladex)
- How many people
- 573 participants
- Where
- 1 siteFinland
- Study dates
- May 1997to Apr 2015
- Phase
- Phase 4
- 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 0 years and older
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Any previous or concurrent treatment of prostate cancer, except TURP, 5-alpha reductase inhibitor, radical prostatectomy or radiotherapy Any medication/treatment affecting sex hormone status
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intermittent Vs Continuous Androgen Deprivation in Patients With Advanced Prostate Cancer
To compare intermittent androgen deprivation (LHRHa treatment) with continuous androgen deprivation (LHRHa treatment or orchidectomy)
- Being tested
- Goserelin (Zoladex)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goserelin (Zoladex)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Time To Progression (TTP)
Secondary outcomes (1)
Overall and prostate cancer-specific survival, time to treatment failure, 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 posted17 Feb 2006 (estimated)
- Study startMay 1997
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Patients With T1-4 Advanced 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 573 participants
Sponsor and investigators
- Lead sponsor
- Tampere University
- Sponsor type
- University, hospital or other
- Collaborators
- Finnish Prostate Cancer Group
- Investigators
- Teuvo L Tammela, Professor, Principal investigator, Tampere University Central Hospital, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00293670
- Sponsor's protocol ID
- 9393FN/0001
- Status last verified
- Feb 2006
- First submitted
- 16 Feb 2006
- Last updated
- 17 Feb 2006
- Results posted
- No
Publications
Salonen AJ, Taari K, Ala-Opas M, Viitanen J, Lundstedt S, Tammela TL; FinnProstate Group. Advanced prostate cancer treated with intermittent or continuous androgen deprivation in the randomised FinnProstate Study VII: quality of life and adverse effects. Eur Urol. 2013 Jan;63(1):111-20. doi: 10.1016/j.eururo.2012.07.040. Epub 2012 Jul 27.
PubMed 22857983Salonen AJ, Taari K, Ala-Opas M, Viitanen J, Lundstedt S, Tammela TL; FinnProstate Group. The FinnProstate Study VII: intermittent versus continuous androgen deprivation in patients with advanced prostate cancer. J Urol. 2012 Jun;187(6):2074-81. doi: 10.1016/j.juro.2012.01.122. Epub 2012 Apr 11.
PubMed 22498230
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Vs Continuous Androgen Deprivation in Patients With Advanced Prostate Cancer
- ClinicalTrials.gov ID
- NCT00293670
- Acronym / sponsor ID
- 9393FN/0001
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 573 participants
- Lead sponsor
- Tampere UniversityUniversity, hospital or other
- Collaborators
- Finnish Prostate Cancer Group
- Study start
- May 1997
- Study completion
- Apr 2015
- First posted
- 17 Feb 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.
To compare intermittent androgen deprivation (LHRHa treatment) with continuous androgen deprivation (LHRHa treatment or orchidectomy)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 0 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Any previous or concurrent treatment of prostate cancer, except TURP, 5-alpha reductase inhibitor, radical prostatectomy or radiotherapy Any medication/treatment affecting sex hormone status
- -
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 |
|---|---|---|
| Goserelin (Zoladex) | Drug | – |
Primary outcome
Time To Progression (TTP)
1 secondary outcome
Overall and prostate cancer-specific survival, time to treatment failure, 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 17 Feb 2006.
- Derived from this study: PubMed 22857983Salonen AJ, Taari K, Ala-Opas M, Viitanen J, Lundstedt S, Tammela TL; FinnProstate Group. Advanced prostate cancer treated with intermittent or continuous androgen deprivation in the randomised FinnProstate Study VII: quality of life and adverse effects. Eur Urol. 2013 Jan;63(1):111-20. doi: 10.1016/j.eururo.2012.07.040. Epub 2012 Jul 27.
- Derived from this study: PubMed 22498230Salonen AJ, Taari K, Ala-Opas M, Viitanen J, Lundstedt S, Tammela TL; FinnProstate Group. The FinnProstate Study VII: intermittent versus continuous androgen deprivation in patients with advanced prostate cancer. J Urol. 2012 Jun;187(6):2074-81. doi: 10.1016/j.juro.2012.01.122. Epub 2012 Apr 11.
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.
Teuvo L Tammela, Professor principal investigator
Tampere University Central Hospital, Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Goserelin (Zoladex) in people with Patients With T1-4 Advanced Prostate Cancer, run by Tampere University at 1 site in Finland.
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 0 inclusion and 2 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 17 Feb 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 Finland. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Time To Progression (TTP). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00293670, which also lists 2 linked publications.
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 17 Feb 2006.